Monday, September 1, 2008

Injections of Hope - washingtonpost.com

Injections of Hope - washingtonpost.com

Injections of Hope
Doctors Promote Offshore Stem Cell Shots, but Some Patients Cry Foul

By Brian Vastag
Special to The Washington Post
Tuesday, September 2, 2008; HE01

Avast human experiment is afoot. And no one is taking good notes.

Fueled by demand from desperate patients, dozens of companies around the globe are peddling stem cell injections for $15,000 to $50,000 and more. Based merely on the claims made by these companies, at least a few thousand patients from the United States have paid for stem cells overseas.

Patients dart across the border to Mexico or jet to the Caribbean, India, China and elsewhere for injections of stem cells from embryos, fetuses, umbilical cords and the patients' own fat, blood and bone marrow. These shots would be illegal in the United States, where the Food and Drug Administration has yet to approve any such treatments.

Online ads promoting this therapy target people with spinal injuries, Lou Gehrig's disease, heart failure and other tough-to-treat conditions, promising improvements and even cures.

"Diseases and conditions such as diabetes, multiple sclerosis, cerebral palsy . . . are all being successfully treated," claims one site, returninghope.com. When asked to support the claims, Brian Dardzinksi, who operates the site from Bangkok and Hong Kong, provided one medical journal article describing the treatment of incontinence with muscle stem cells, an Austrian study now under investigation for possible ethics problems.

Dardzinski has no medical background and acts as a broker, matching U.S. patients with stem cell providers overseas. "Several hundred patient inquiries a month is not uncommon," he said. "I'm just a businessman trying to do some good."

Because the companies operate offshore, they are not subject to the FDA's strict safety regulations. And because they collect little, if any, data, it's impossible to assess whether their treatments work.

The business is drawing sharp concern from academic researchers.

"It's almost evil, because it preys on the fears and the hopes of the most vulnerable people," said Evan Snyder, a stem cell researcher at the Burnham Institute in La Jolla, Calif.

"There are a lot of scams out there," said Wise Young, a spinal cord injury researcher at Rutgers, the state university of New Jersey. "People should be very careful."

Barbara Hanson and Jeannine Richardson discovered the risks after a trip to a stem cell clinic in Tijuana, Mexico, last year.

The women, who met in an online support forum for people with chronic obstructive pulmonary disease, learned of a company called Stem Cell Biotherapy, which has offices in Agoura Hills, Calif., and advertised online. Hanson says one of the company's doctors, Burton Feinerman, told her he had taken 10 COPD patients to Tijuana and all had improved enough to discard their portable oxygen tanks.

Because Hanson and Richardson helped recruit patients for Stem Cell Biotherapy from the online forum, the company dropped its price from $25,000 to about $17,000 for each of them, the women said. Hanson borrowed the money from her mother, and Richardson took cash advances on her credit cards.

But a week after traveling to Tijuana at Feinerman's direction and getting injections, both women spiked fevers and developed flulike symptoms. Richardson was hospitalized for eight days after returning home to New Hampshire.

"It was like the worst pneumonia I'd ever had," said Hanson, who lives near Denver. "It was so bad I honestly thought I was going to die." Hanson believes the injections made her and Richardson sick; Richardson isn't sure.

Feinerman did not return calls asking for comment. But Casey Navabi, Stem Cell Biotherapy's chief executive, said Hanson and Richardson grew embittered after he decided not to use the women's printing business. (Hanson says that the company still owes her money.)

"They wanted our business, and we didn't give it to them," he said. "Now they're putting out a lot of negative comments about us. I view it as extortion."

About 25 patients from the forum eventually visited the Tijuana clinic, Hanson says, with Stem Cell Biotherapy acting as the broker. "None of us has gotten off of oxygen," Hanson said. She and Richardson say the injections might have slowed the course of their illnesses (they both rely on bottled oxygen less than before), but Hanson is furious. "I can't say I didn't get any [benefit]," she said. "But I sure didn't get my money's worth, and I sure didn't get what I was promised."
Patient Complaints

That refrain is common among those who pay for stem cells. Nine years ago, Fia Richmond of Santa Barbara, Calif., took her brain-damaged 3-year-old son, Palmer, to a clinic in the Bahamas run by William C. Rader, a psychiatrist from Malibu, Calif.

Palmer was unable to walk or talk, and Richmond said she decided to take a chance on Rader, who offered to inject Palmer with fetal stem cells for $25,000, telling her the cells might help her son.

When the pair returned home, Palmer began having seizures, Richmond said.

Rader disputes this. "The only communications from Mrs. Richmond [post-treatment] . . . were all very positive," he wrote in an e-mail.

Now 12, Palmer is still unable to walk or talk, his mother said.

"It was devastating to come back and for my son to not do well, to have a lot of seizures where he hadn't had seizures for years," Richmond said. She said she "had taken a step too far with my son being a guinea pig."

Another mother whose developmentally disabled child received Rader's injections, Dianne Caprio of Monterey, Calif., said: "There was no follow-up at all. He never called us. He did nothing but collect money." Caprio said her daughter Courtney received two rounds of injections, one in the Bahamas and one at Rader's clinic in the Dominican Republic. "Initially we thought we saw some improvements, but nothing really substantial," Caprio said. "Looking back, it might have been wishful thinking. I think he's just preying on desperate people." Rader provided notes that show the Caprio family originally thought they saw some initial improvement in Courtney. The notes detail several phone calls from Rader's office to the family to arrange more cell injections.

The government of the Bahamas closed Rader's clinic in 2000 after a critical television report. He moved to the Dominican Republic, where he meets and injects patients on weekends. In a phone interview, Rader said he gets his product from a lab in the republic of Georgia, where technicians extract stem cells from the brains and livers of aborted fetuses. Rader claimed in an interview to have injected more than 1,000 people with such cells since 1997.

Rader recruits patients from his Malibu office and via the Web site of his company, Medra Inc. Earlier in his career, he operated eating disorder clinics and reported medical news for a television station in Los Angeles.

During four hours of phone interviews, Rader described himself as a misunderstood pioneer. He said that he has tried to educate several physicians about the benefits of stem cell injections but that they refuse to accept that he has helped patients. Rader said his treatments have reversed Down syndrome, stopped intractable seizures in children, cured AIDS in at least two patients and boosted the immune systems of cancer patients undergoing chemotherapy. "If I'm telling the truth, it will change the face of medicine," he said.

Rader is not interested in talking to the FDA about conducting fully documented clinical studies. He said that if he opens his work to scrutiny, the FDA and the pharmaceutical industry will squelch him. "I trust no one," he said.
Short on Science?

Quackwatch, a Web site devoted to outing doctors practicing unsafe and unproven medicine, highlighted Rader and other overseas stem cell providers in 2006. "Their theories and methods are simplistic; their treatments may have adverse effects; they offer no credible outcome data; and their promises go far beyond what is now possible," wrote the site's founder, Stephen Barrett.

Rader dismissed the criticism, questioning Barrett's credibility. He and other stem cell providers point to testimonials, posting videos and blogs from patients who say they've improved. Research from Harvard University and elsewhere on patient decision making shows this to be smart marketing: Patients pay far more attention to stories than to statistics.

But when determining whether a medical intervention really works, "testimonials mean absolutely nothing," said Snyder, the Burnham Institute researcher. "They're worthless."

One reason: They don't allow for the possibility of spontaneous recovery. A 2007 study in the journal Spinal Cord found that "almost all" spinal cord injury patients spontaneously regain some feeling and movement.

And then there's the placebo effect: If the brain thinks it's getting a treatment, the body often feels better. Medical journals are littered with descriptions of drugs and other interventions that displayed initial promise only to wilt under the rigors of placebo-controlled studies, where some patients get the intervention and some get a sugar pill or other non-treatment.

Clinical trials in Parkinson's disease offer perhaps the most stunning demonstration of the placebo effect. In the trials, doctors transplanted fetal cells into the brains of some Parkinson's patients, hoping the cells would make the brain messenger dopamine, which diminishes with the disease. Other patients got holes drilled in their heads but no cells. Over a year, both groups showed some improvements, according to a 2004 report in the Archives of General Psychiatry. Further, of the patients who did not receive the cells, those who thought they had fared better than those who thought they had not.

In other words, believing makes the "medicine" work.

Likewise, patients who travel for stem cells are strongly motivated to feel better, said Jamie Heywood, founder of the online support network PatientsLikeMe. "If you spend so much money and sacrifice so much to do something, it's difficult to believe it didn't help," said Heywood, who tracks several offshore stem cell providers.
More Study Needed

The disease that most interests Heywood is amyotrophic lateral sclerosis, or ALS, also known as Lou Gehrig's disease.

In 1999, after doctors diagnosed his brother Stephen with the fatal disease, Heywood organized the first human stem cell trial in the country for ALS. After Heywood won FDA approval for the safety study, his brother and two other ALS patients received spinal injections of stem cells from their own blood at Thomas Jefferson University Hospital in Philadelphia. None of the patients improved. Stephen died in 2006.

Since then, about 20 ALS patients from PatientsLikeMe have received offshore stem cell injections, Heywood said. None has shown lasting improvements, according to patient reports and surveys on the site. "The evidence to date is that the simple 'put them in and they will heal you' model isn't going to work" against ALS, Heywood said.

The only way to know if the injections help patients, academics say, is to subject them to fully documented, placebo-controlled studies. That's why the 2,500-member International Society for Stem Cell Research (ISSCR) is developing guidelines to encourage overseas stem cell companies to collect and share data. A draft of the guidelines says the society "condemns" injections of stem cells outside rigorous studies.

At the same time, a few academics voice regret about overplaying the promise of stem cells. Reams of evidence suggest various types of stem cells do possess healing properties, but figuring out how to harness that power will take years of careful human trials, they say. "There's been extremely high levels of hope and hype" surrounding stem cells, said Laurie Zoloth, a bioethicist at Northwestern University.

"I take as much blame for creating this aura that stem cells can do anything as anyone else," Snyder said. He and other academics offer a rule of thumb: Avoid companies asking for money.

"There's a standard in clinical research: Patients don't pay for it," said George Daley, president of ISSCR and a researcher at the Harvard Stem Cell Institute. Snyder said this rule might screen out "some legitimate operations," but it will also weed out the scams. Legitimate clinical trials are usually funded by the government or by private companies, he said.

"At the beginning you think, 'I'm going to be cured for life, I'm going to get better every day,' " said Hanson, the lung patient who traveled to Tijuana. "Well, that isn't true."

Brian Vastag is a freelance science writer in Washington. Comments:health@washpost.com.

Bloomberg.com: News

Bloomberg.com: News: "Blood Vessels Made From Human Adult Stem Cells Grown in Mice

By Rob Waters

Blood Vessels Made From Human Adult Stem Cells Grown in Mice

By Rob Waters

July 18 (Bloomberg) -- Stem cells drawn from the blood system of adult humans or the umbilical cord blood of newborns, injected into mice, formed viable vessels that may one day deliver oxygen-rich blood to damaged organs, researchers said.

After one week, the cells spontaneously connected to one another and to the existing blood vessels of the rodents to form extensive networks that continued to transport blood over the next three weeks. The findings from Harvard Medical School were published in the journal Circulation.

If the process can be proven safe and replicated in people, it could provide a way to repair blood-starved regions of organs that have been damaged by heart attacks or other conditions that impair circulation. Unlike other experiments that have coaxed adult cells to perform new functions, the Harvard team didn't perform any genetic manipulation, said Joyce Bischoff, an associate professor at Harvard and Children's Hospital Boston.

``It's kind of a self-assembly process; they do the job on their own,'' Bischoff said in a telephone interview today. ``We mix them together and they talk to each other and give directions on how to form a blood vessel.''

The team drew samples from blood and bone marrow, isolated the stem cells within each, then mixed them with a gel material that is liquid when cold and solidifies at body temperature. The gel, after firming, formed scaffolds the cells could grow on. The materials were combined into a single suspension and injected into mice, Bischoff said.

The cells derived from blood ``form the lining of the blood vessel'' known as the endothelium and the bone marrow cells ``wrap around the endothelial cells to form the smooth muscle layer,'' Bischoff said.

Goal: Two-Day Vessels

Because damaged heart tissue or festering wounds need blood and oxygen quickly to heal, ``our goal is to speed it up to form blood vessels within one or two days,'' Bischoff said.

The advance could propel the emerging field of tissue engineering, which seeks to use stem cells and scaffolds to build replacement tissues and organs for people with various conditions. One closely held company, Tengion, based in East Norriton, Pennsylvania, is testing synthesized bladders in human trials and developing ways to create blood vessels and kidneys.

Before the method can be tested in humans, researchers will need to show that the cells they've isolated and expanded are pure and uncontaminated by other cell types. The technique will need to be proven safe in many more animals and the process will need to be done in a completely sterile environment that's certified by regulators.

``Science moves very slowly,'' Bischoff said.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.
Last Updated: July 18, 2008 16:00 EDT

Bloomberg.com: News

Bloomberg.com: News: "Glaxo Gives Harvard $25 Million for Stem Cell Study (Update2)

By John Lauerman and Brian Kladko

Glaxo Gives Harvard $25 Million for Stem Cell Study (Update2)

By John Lauerman and Brian Kladko

July 24 (Bloomberg) -- GlaxoSmithKline Plc, Europe's largest drugmaker, will give the Harvard Stem Cell Institute at least $25 million over five years to speed development of treatments using the technology.

Grants will support work at the institute and at least four hospitals affiliated with Harvard University, Glaxo said today in an e-mailed statement. Scientists will use the money to explore using stem cells to fight cancer, diabetes and obesity along with nerve, heart, and musculoskeletal diseases, Harvard said in a statement on its Web site.

The funding ``will allow the Harvard Stem Cell Institute to ultimately fulfill its promise of advancing stem cell science to benefit patients,'' said Brock Reeve, the institute's executive director, in the statement. Glaxo, based in London, also said it will fund ``seed'' grants aimed at early stage research.

The stem cell institute, a collection of researchers from schools of the Cambridge, Massachusetts, university and from affiliated institutions in Boston, was created four years ago. It plans to occupy part of a complex being built in the Allston section of Boston, the first step in Harvard's expansion into that neighborhood. The building is expected to be completed in 2011, said B.D. Colen, a Harvard spokesman.

Stem cells from embryos have the ability to become any of the roughly 210 cell types in the human body. Harvard scientists also conduct research with adult stem cells that replenish specific tissues and organ.

Private funding has become more importance since 2001 when President George W. Bush restricted use of federal money for research on embryonic stem cells because embryos are destroyed. Colen, the Harvard spokesman, said the institute had previously raised about $70 million, mostly from individual donors.

The affiliated hospitals collaborating on the research are the Joslin Diabetes Center, Massachusetts General Hospital, Brigham and Women's Hospital and the Dana-Farber Cancer Institute, all in Boston, according to the Harvard statement.

To contact the reporters on this story: John Lauerman in Boston at jlauerman@bloomberg.net; Brian Kladko in Boston at bkladko@bloomberg.net.
Last Updated: July 24, 2008 13:54 EDT

Bloomberg.com: News

Bloomberg.com: News: "Glaxo Gives Harvard $25 Million for Stem Cell Study (Update2)

By John Lauerman and Brian Kladko

Glaxo Gives Harvard $25 Million for Stem Cell Study (Update2)

By John Lauerman and Brian Kladko

July 24 (Bloomberg) -- GlaxoSmithKline Plc, Europe's largest drugmaker, will give the Harvard Stem Cell Institute at least $25 million over five years to speed development of treatments using the technology.

Grants will support work at the institute and at least four hospitals affiliated with Harvard University, Glaxo said today in an e-mailed statement. Scientists will use the money to explore using stem cells to fight cancer, diabetes and obesity along with nerve, heart, and musculoskeletal diseases, Harvard said in a statement on its Web site.

The funding ``will allow the Harvard Stem Cell Institute to ultimately fulfill its promise of advancing stem cell science to benefit patients,'' said Brock Reeve, the institute's executive director, in the statement. Glaxo, based in London, also said it will fund ``seed'' grants aimed at early stage research.

The stem cell institute, a collection of researchers from schools of the Cambridge, Massachusetts, university and from affiliated institutions in Boston, was created four years ago. It plans to occupy part of a complex being built in the Allston section of Boston, the first step in Harvard's expansion into that neighborhood. The building is expected to be completed in 2011, said B.D. Colen, a Harvard spokesman.

Stem cells from embryos have the ability to become any of the roughly 210 cell types in the human body. Harvard scientists also conduct research with adult stem cells that replenish specific tissues and organ.

Private funding has become more importance since 2001 when President George W. Bush restricted use of federal money for research on embryonic stem cells because embryos are destroyed. Colen, the Harvard spokesman, said the institute had previously raised about $70 million, mostly from individual donors.

The affiliated hospitals collaborating on the research are the Joslin Diabetes Center, Massachusetts General Hospital, Brigham and Women's Hospital and the Dana-Farber Cancer Institute, all in Boston, according to the Harvard statement.

To contact the reporters on this story: John Lauerman in Boston at jlauerman@bloomberg.net; Brian Kladko in Boston at bkladko@bloomberg.net.
Last Updated: July 24, 2008 13:54 EDT

Bloomberg.com: News

Bloomberg.com: News: "Brain Cells Made From Skin of 80-Year-Olds With Lou Gehrig's

By Rob Waters

Brain Cells Made From Skin of 80-Year-Olds With Lou Gehrig's

By Rob Waters

July 31 (Bloomberg) -- Researchers at Harvard University have made motor neurons, the brain cells that degenerate in patients with Lou Gehrig's disease, from skin cells taken from two elderly sisters with the condition.

The advance, published today in the journal Science, used a technique developed during the last two years that gives adult cells the same power as those from embryos to turn into any cell type in the body. The disease, also known as amyotrophic lateral sclerosis, or ALS, robs patients of muscular control and may eventually lead to paralysis.

The Harvard team took the first step toward fulfilling one of the promises of the new technology by creating lines of human stem cells from the tissue of patients with a genetic disease. The neurons created may, over time, show early signs of ALS, a disease that normally strikes people in their 50s and 60s, allowing researchers to study its workings and hunt for cures.

``We now have in the culture dish cells which have the same genetic make-up as do the patients,'' said Christopher Henderson, a researcher at Columbia University in New York and co-author of the study, on a call with reporters yesterday. ``They are the very cells that are affected in the disease. This provides us the opportunity to study these motor neurons and see whether they behave in a manner that mimics the disease.''

Yamanaka Method

The neural cells were derived by the team using a method first developed by Shinya Yamanaka, a researcher at Kyoto University in Japan. It involves inserting four different genes into the skin cells, causing them to revert to a primordial state similar to embryonic stem cells.

The immediate potential of the method is that it will reveal the chemical and molecular changes that occur in motor neurons before they degenerate. It also will allow researchers to test libraries of chemical compounds on the cells to see if they can intervene in this process.

Because Yamanaka's method uses viruses to ferry the genes into the cells, it can trigger cancer and other undesired effects. Research teams around the world are now looking for alternative methods of reprogramming cells without using viruses. Unless a safer method is found, the technique can't be used to make treatments.

Kevin Eggan, the lead author of the study, said Yamanaka's technique provided a way to proceed with research that he and his colleagues had hoped to conduct by cloning patients' skin cells, the same method used in 1996 to create Dolly the sheep.

Women as Donors

In that technique, the nucleus of a patient's skin cell is inserted into a woman's egg cell whose genetic material has been removed. Eggan said he and other scientists haven't obtained enough egg cells from women to successfully clone human cells because of ethical rules that bar researchers from paying egg donors for their time.

The Harvard Stem Cell Institute, where Eggan works, has spent about $100,000 on newspaper advertisements asking young women to donate their eggs for research. While the promotion generated hundreds of phone calls from interested women, only one provided an egg.

``When told they couldn't be compensated for their time, they rapidly lost interest,'' Eggan said during the call. Women have to spend about 60 hours to provide eggs, partly to undergo uncomfortable and sometimes risky hormone treatments to stimulate the release of multiple eggs, Eggan said.

The new finding shows the skin cells of older patients can be used to make stem cells, even though researchers had been concerned that their age might prevent the process from working. The cells came from sisters who are 82 and 89 years old and are among the oldest living patients with ALS, according to the study.

Eggan said his team also is trying similar work using cells from patients with other forms of ALS.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.
Last Updated: July 31, 2008 14:00 EDT

Bloomberg.com: News

Bloomberg.com: News: "Advanced Cell Makes Blood From Embryonic Stem Cells (Update1)

By John Lauerman

Advanced Cell Makes Blood From Embryonic Stem Cells (Update1)

By John Lauerman

Aug. 19 (Bloomberg) -- Advanced Cell Technology Inc. scientists said they have developed a way to make human blood from embryonic stem cells, opening the door to a potential new source of often-scarce supplies.

The red blood cells can carry and deliver oxygen, and have other vital features of normal cells, Alameda, California-based Advanced Cell said in the study, published today online by the journal Blood. The research, which involved scientists from the University of Illinois at Chicago and the Mayo Clinic in Rochester, Minnesota, produced as many as 100 billion red cells from a single dish of stem cells.

Blood shortages delay hundreds of surgeries in the U.S. annually, and the military is seeking sources of fresh blood for combat casualties. Embryonic stem cells, which can make any cell type, might offer a fresh blood source for hospitals and the battlefield, said Robert Lanza, vice president of medical and scientific development for Advanced Cell.

``This is a scalable process, and there's virtually no limit to the amount of blood you could produce, given the time and resources,'' Lanza said yesterday in a telephone interview from his office in Worcester, Massachusetts.

Advanced Cell gained a penny, or 23 percent, to 5 cents in over the counter trading at 4 p.m. New York time, and has lost 84 percent in the past 12 months.

About 15 million units of blood were collected in the U.S. in 2004, according to the Nationwide Blood Collection and Utilization Survey Report in 2005, the latest year for which data are available. Regional and local supplies fall short when adequate numbers of donors can't be found.

Mouse Tissue

Lanza's team put the embryonic stem cells on a layer of mouse tissue that provides nourishment, where they grew into blood cells progenitors called hemangioblasts. The scientists used a cocktail of chemicals to get the progenitor cells to make red blood cells.

Crucial to the experiment was making sure the blood cells would load and unload oxygen at the proper times, their normal function in the body. About 60 percent of the red blood cells also lacked a nucleus, the structure that contains DNA in most cells. Normal red blood cells have no nuclei.

The scientists were able to make enough blood to fill a small test-tube. While testing the cells in animals and people would probably take several years, making greater amounts of blood is within reach, he said.

``It's clearly doable,'' he said. ``It's just a matter of improving efficiency and containing costs.''

Need For Blood

At least 546 elective surgeries were delayed in 2004 because of short blood supplies, according to the report. New York issued an urgent appeal for blood donors in 2006 when supplies fell dangerously low, and last year the American Red Cross issued a similar alert for New Jersey and parts of Pennsylvania.

The U.S. Defense Advanced Research Project Agency, the Defense Department's research and development office, is encouraging new ways to generate blood for use on the battlefield. At a workshop last year, defense scientists described their desire to develop an ``in-theater culture system'' to produce fresh red blood cells to treat injured soldiers.

Using embryonic stem cells for this purpose has been hampered by President George W. Bush's policy, which restricts government funding for research to designated existing lines of cells, Lanza said. None of the Bush-approved colonies of stem cells are from embryos with O-negative blood, the universal donor blood type, which is ideal for civilian and military applications, he said.

Alternative Source

An alternative source of safe, fresh blood would be good news for patients and hospitals, said Louis Katz, past president of America's Blood Centers, a Washington-based group of private collection companies. Donated blood must be tested for numerous infections, such as the AIDS virus, and some research suggests that even short-term storage may harm blood vessels in transfused people, he said.

``A robust supply of red blood cells is a great thing,'' Katz said yesterday in a telephone interview. ``I don't care if it comes out of a vat or a donor.''

Katz's Mississippi Valley Regional Blood Center in Davenport, Iowa, charges about $200 for a unit of blood. Each packet undergoes about $55 worth of testing for HIV, liver viruses and other contaminants, he said.

New tests are added as germs, such as West Nile virus, are discovered to be transmitted through transfused blood. Emory University in Atlanta said yesterday that it will receive $8 million over five years from the government to find ways to protect babies with blood cancers from transfusion-related infections.

Blood from embryonic stem cells could be produced free of such infections, and without immune cells that can attack transfusion recipients, Lanza said. He produced his cells from four embryonic lines, one supplied by the government, two made by Advanced Cell, and one from the Harvard Stem Cell Institute in Cambridge, Massachusetts.

To contact the reporter on this story: John Lauerman in Boston at jlauerman@bloomberg.net.
Last Updated: August 19, 2008 16:25 EDT

Bloomberg.com: News

Bloomberg.com: News: "Harvard Team Makes 10 Disease-Bearing Stem Cell Lines (Update2)

By Rob Waters

Harvard Team Makes 10 Disease-Bearing Stem Cell Lines (Update2)

By Rob Waters

Aug. 7 (Bloomberg) -- Harvard University scientists have made lines of stem cells, able to turn into any other cell in the body, from bits of skin or blood of 10 patients with genetic diseases including muscular dystrophy and juvenile diabetes.

The findings will help researchers decipher the workings of these diseases, enabling them to study what happens as cells that carry a condition's genetic seeds develop and age. The lines will be made available for a ``nominal fee'' to researchers around the world, the Harvard scientists said.

Teams at the Harvard Stem Cell Institute in Cambridge, Massachusetts, created the lines using a technique that reprograms cells to give them the same power as those from embryos to become any of the roughly 210 cell types in the body. Their advance was described in a paper appearing today in the journal Cell.

The advance will ``allow researchers for the first time to get access'' to cells that are defective in a particular disease ``and to watch the disease progress in a dish, to watch what goes right or wrong,'' said Doug Melton, a Harvard cell biologist and co-director of the institute.

The Harvard teams created the new lines from tissue taken from 10 patients who ranged in age from a 3-month-old child with a form of immune deficiency sometimes known as ``bubble boy disease'' to a 57-year-old with Parkinson's. Last week, another Harvard team said they'd performed the same feat using the skin of two patients in their 80s with the neurodegenerative condition known as Lou Gehrig's disease.

Yamanaka Technique

The technique used to create the stem cells, developed by Shinya Yamanaka of Kyoto University in Japan, has captivated scientists and transformed the research they're performing. The method involves using viruses to insert four different genes into skin cells. The genes turn on a process that causes the cells to revert to a primordial state similar to embryonic stem cells.

Yamanaka announced his breakthrough two years ago at a scientific meeting in Toronto, when he described how he had been able to endow skin cells from mice with the power of those from embryos. Other advances followed rapidly. Last November, two research teams, one led by Yamanaka and the other by James Thompson of the University of Wisconsin in Madison, announced independently that they'd done the same thing with the skin of living people.

Research teams around the world have rushed to use Yamanaka's technique for creating what he calls induced pluripotent stem cells, or IPS cells, for two key reasons. It is relatively easy and inexpensive to perform and it doesn't require the use of human embryos or unfertilized eggs, both of which can be difficult to obtain.

Ethical Concerns

Because human embryos aren't used or harmed to create the IPS cells, the method sidesteps ethical concerns that have dogged researchers. Religious and political leaders including President George W. Bush have objected to traditional stem cell research because embryos are destroyed in the process of creating the lines.

Still, because Yamanaka's technique uses viruses and genes that are known to cause cancer, lines created with this method can't be used as treatments. They will allow researchers to peer into the complex molecular and genetic processes that occur in defective cells as they develop, giving them a greater understanding of how and why disease begins.

``We are so ignorant at the moment we don't even know if when patients gets diabetes, they all get it the same way,'' Melton said in a conference call yesterday with reporters. ``There could be 50 different ways of getting Type 1 diabetes.''

Next Steps

George Daley, the lead author of today's paper and a researcher at Children's Hospital in Boston who studies blood diseases, said he and his colleagues will now take the newly minted stem cells and coax them to become blood cells of various types.

He said he hopes that by comparing them with normal healthy blood, ``we can find the particular development points where the defects arise and we can look at gene-repair strategies.''

He and other scientists also will be able to test thousands of existing drugs to see whether any of them remedy the defects, he said.

Daley said the new lines, and those developed in the future, will be maintained in a new laboratory at Massachusetts General Hospital in Boston. Setting up the lab will enable other researchers to obtain the Harvard cells for their own experiments, something that didn't happen quickly after embryonic stem cells were first isolated in 1998, he said.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.
Last Updated: August 7, 2008 15:03 EDT

Bloomberg.com: News

Bloomberg.com: News: "Harvard's Cell `Makeover' May Spur Diabetes Therapy (Update1)

By Rob Waters

Harvard's Cell `Makeover' May Spur Diabetes Therapy (Update1)

By Rob Waters

Aug. 27 (Bloomberg) -- Using a kind of biological alchemy, Harvard University researchers have turned one type of cell found in the pancreas of mice into the variety that secretes the hormone insulin.

If the technique can be used safely in humans, it may one day provide a treatment for diabetes, which occurs when the body either can't produce, or else makes too little of, the insulin needed to process blood sugar. The same approach might be used to make heart, brain, or liver cells from other existing cells and treat diseases in those organs, said Jeanne Loring, a stem-cell scientist who wasn't involved in the findings.

The technique marries gene therapy and stem-cell research ``in a completely novel way,'' said Loring, the director of the Scripps Research Institute's Center for Regenerative Medicine, in La Jolla, California. ``It turns the whole field on its head.''

The research team was led by Douglas Melton, a cell biologist and co-director of the Harvard Stem Cell Institute, in Cambridge, Massachusetts. The scientists injected viruses bearing three genes into the mice, transforming a common pancreatic cell known as an exocrine cell into the much rarer beta cell that makes insulin. Their findings were published in the journal Nature.

Melton said he aims to refine the technique, show that it can be done safely, and begin human clinical trials within two to five years in diabetes patients.

``We were able to flip the cell from one state into another, what one of the younger students in my lab calls an extreme makeover,'' Melton said yesterday in a conference call with reporters.

'Direct Reprogramming'

The Harvard researchers are calling the process ``direct reprogramming.'' Previously, Shinya Yamanaka of Kyoto University turned adult cells into stem cells that can then be made into other cell types for therapy. Unlike Yamanaka, the Harvard scientists converted one adult cell into another without first making it into a stem cell.

The research exploits the fact that every cell in a person or animal contains DNA with the complete set of genetic instructions required to create that individual. By turning select genes on and off, scientists can transform existing cells so they start looking and acting like others.

Melton and his team spent three years searching for so- called transcription factors, which control proteins that in turn switch other genes on and off. They started with 1,100 candidate genes and narrowed the field to 28 that are involved in forming the part of the pancreas where beta cells are found.

Nine Genes, Then Three

Finally, they settled on nine genes they guessed might be involved and began a trial-and-error process, injecting them into the pancreases of mice and eliminating one at a time. Eventually, they found that just three genes were needed and that 20 percent of the exocrine cells they injected turned into beta cells, Melton said.

``Once the switch happens, you're changed from a Celtic to a Laker, if you like,'' Melton said in an interview on June 12. Unlike trades of players between professional basketball teams in the U.S., this represents ``a stable, permanent reprogramming,'' he said.

The two cell types have different appearances under a microscope. Exocrine cells look like cobblestones, while beta cells are smaller and shaped like spindles, the team reported in the Nature paper. To be certain the same cells transformed, they stained the original exocrine cells with special dyes and found the dye in the beta cells.

Safer Viruses

The viruses used to ferry the genes by Melton's team are known as adenoviruses and are considered safer than the retroviruses used in Yamanaka's work, Melton said. Adenoviruses have been widely used in gene therapy trials. Also, none of the three genes used are known to cause cancer, unlike the genes Yamanaka used, according to Melton.

Still, Melton said he aims to find still another method of transforming cells without using viruses at all, to ensure the process is safe.

He and his team will be exploring two different strategies for using the technique as a treatment, Melton said. One would involve directly injecting the genes into a human pancreas, as they did with the mice.

In the other, the scientists would take exocrine cells from the cadavers of organ donors, convert them in the laboratory to beta cells, coax them to congregate into clusters known as islets, and transplant those into patients. This may be the safest way to proceed, Melton said.

Researcher's Children

Melton, who has two children with the Type 1 form of diabetes, said he wakes up every day thinking about how to make insulin-producing beta cells. People with that condition have a defect in their immune system which causes it to attack and destroy their own beta cells.

Most of the almost 24 million people in the U.S. with diabetes have the Type 2 form, which generally develops in adulthood and is linked to obesity. Both forms can damage the kidneys, eyes, heart, limbs and nerves.

The most immediate application of Melton's work would be to replace the depleted stock of beta cells in people with severe Type 2 diabetes whose bodies can no longer make insulin. It wouldn't help people with the Type 1 form, like Melton's children, because the new beta cells would most likely be attacked by the same autoimmune process that causes the disease. Other strategies will be needed to block or reverse the immune attack, Melton said.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.
Last Updated: August 27, 2008 16:50 EDT

Friday, August 29, 2008

Friend or Foe? Crows Never Forget a Face, It Seems - NYTimes.com

Friend or Foe? Crows Never Forget a Face, It Seems - NYTimes.com: "Friend or Foe? Crows Never Forget a Face, It Seems

Friend or Foe? Crows Never Forget a Face, It Seems

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By MICHELLE NIJHUIS
Published: August 25, 2008

Crows and their relatives — among them ravens, magpies and jays — are renowned for their intelligence and for their ability to flourish in human-dominated landscapes. That ability may have to do with cross-species social skills. In the Seattle area, where rapid suburban growth has attracted a thriving crow population, researchers have found that the birds can recognize individual human faces.
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Top, Keith Brust; Jeff Walls

I KNOW YOU John M. Marzluff, a wildlife biologist tested crows’ ability to distinguish between faces.
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The researchers used a simple hat and masks to test the animals' abilities.

John M. Marzluff, a wildlife biologist at the University of Washington, has studied crows and ravens for more than 20 years and has long wondered if the birds could identify individual researchers. Previously trapped birds seemed more wary of particular scientists, and often were harder to catch. “I thought, ‘Well, it’s an annoyance, but it’s not really hampering our work,’ ” Dr. Marzluff said. “But then I thought we should test it directly.”

To test the birds’ recognition of faces separately from that of clothing, gait and other individual human characteristics, Dr. Marzluff and two students wore rubber masks. He designated a caveman mask as “dangerous” and, in a deliberate gesture of civic generosity, a Dick Cheney mask as “neutral.” Researchers in the dangerous mask then trapped and banded seven crows on the university’s campus in Seattle.

In the months that followed, the researchers and volunteers donned the masks on campus, this time walking prescribed routes and not bothering crows.

The crows had not forgotten. They scolded people in the dangerous mask significantly more than they did before they were trapped, even when the mask was disguised with a hat or worn upside down. The neutral mask provoked little reaction. The effect has not only persisted, but also multiplied over the past two years. Wearing the dangerous mask on one recent walk through campus, Dr. Marzluff said, he was scolded by 47 of the 53 crows he encountered, many more than had experienced or witnessed the initial trapping. The researchers hypothesize that crows learn to recognize threatening humans from both parents and others in their flock.

After their experiments on campus, Dr. Marzluff and his students tested the effect with more realistic masks. Using a half-dozen students as models, they enlisted a professional mask maker, then wore the new masks while trapping crows at several sites in and around Seattle. The researchers then gave a mix of neutral and dangerous masks to volunteer observers who, unaware of the masks’ histories, wore them at the trapping sites and recorded the crows’ responses.

The reaction to one of the dangerous masks was “quite spectacular,” said one volunteer, Bill Pochmerski, a retired telephone company manager who lives near Snohomish, Wash. “The birds were really raucous, screaming persistently,” he said, “and it was clear they weren’t upset about something in general. They were upset with me.”

Again, crows were significantly more likely to scold observers who wore a dangerous mask, and when confronted simultaneously by observers in dangerous and neutral masks, the birds almost unerringly chose to persecute the dangerous face. In downtown Seattle, where most passersby ignore crows, angry birds nearly touched their human foes. In rural areas, where crows are more likely to be viewed as noisy “flying rats” and shot, the birds expressed their displeasure from a distance.

Though Dr. Marzluff’s is the first formal study of human face recognition in wild birds, his preliminary findings confirm the suspicions of many other researchers who have observed similar abilities in crows, ravens, gulls and other species. The pioneering animal behaviorist Konrad Lorenz was so convinced of the perceptive capacities of crows and their relatives that he wore a devil costume when handling jackdaws. Stacia Backensto, a master’s student at the University of Alaska Fairbanks who studies ravens in the oil fields on Alaska’s North Slope, has assembled an elaborate costume — including a fake beard and a potbelly made of pillows — because she believes her face and body are familiar to previously captured birds.

Kevin J. McGowan, an ornithologist at the Cornell Laboratory of Ornithology who has trapped and banded crows in upstate New York for 20 years, said he was regularly followed by birds who have benefited from his handouts of peanuts — and harassed by others he has trapped in the past.

Why crows and similar species are so closely attuned to humans is a matter of debate. Bernd Heinrich, a professor emeritus at the University of Vermont known for his books on raven behavior, suggested that crows’ apparent ability to distinguish among human faces is a “byproduct of their acuity,” an outgrowth of their unusually keen ability to recognize one another, even after many months of separation.

Dr. McGowan and Dr. Marzluff believe that this ability gives crows and their brethren an evolutionary edge. “If you can learn who to avoid and who to seek out, that’s a lot easier than continually getting hurt,” Dr. Marzluff said. “I think it allows these animals to survive with us — and take advantage of us — in a much safer, more effective way.”

Wednesday, August 27, 2008

Groundbreaking Advance Allows for 'Reprogramming' of Adult Cells - washingtonpost.com

Groundbreaking Advance Allows for 'Reprogramming' of Adult Cells - washingtonpost.com

Groundbreaking Advance Allows for 'Reprogramming' of Adult Cells
Research Could Lead to Bevy of Cures, Sidesteps Debate Over Embryonic Stem Cells

By Rob Stein
Washington Post Staff Writer
Wednesday, August 27, 2008; 6:05 PM

Scientists have transformed one type of fully developed adult cell directly into another inside a living animal, a startling advance that could lead to cures for a plethora of illnesses and sidestep the political and ethical quagmires that have plagued embryonic stem cell research.

Through a series of painstaking experiments involving mice, the Harvard biologists pinpointed three crucial molecular switches that, when flipped, completely convert a common cell in the pancreas into the more precious insulin-producing ones that diabetics need to survive.

The feat, published online today by the journal Nature, raises the tantalizing prospect that patients suffering from not only diabetes but also heart disease, strokes and many other ailments could eventually have some of their cells reprogrammed to cure their afflictions without the need for drugs, transplants or other therapies.

"It's kind of an extreme makeover of a cell," said Douglas A. Melton, co-director of the Harvard Stem Cell Institute, who led the research. "The goal is to create cells that are missing or defective in people. It's very exciting."

The findings left other researchers in a field that has become accustomed to rapid advances reaching for new superlatives to describe the potential implications.

"I'm stunned," said Robert Lanza, chief scientific officer of Advanced Cell Technology in Worcester, Mass., a developer of stem cell therapies. "It introduces a whole new paradigm for treating disease."

"I think it's hugely significant," said George Q. Daley, a stem cell researcher at Children's Hospital in Boston. "This is a very spectacular first."

Even the harshest critics of embryonic stem cell research hailed the development as a major, welcome development.

"I see no moral problem in this basic technique," said Richard Doerflinger of the U.S. Conference of Catholic Bishops, a leading opponent of embryonic stems cells because they involve destroying human embryos. "This is a 'win-win' situation for medicine and ethics."

Melton and other researchers cautioned that many years of research lay ahead to prove whether the development would translate into cures.

"It's an important proof of concept," said Lawrence Goldstein, a stem cell researcher at the University of California, San Diego. "But these things always look easier on the blackboard than when you have do them in actual patients."

Although the experiment involved mice, Melton and other researchers were optimistic the approach would work in people.

"You never know for sure -- mice aren't humans," Daley said. "But the biology of pancreatic development is very closely related in mice and humans."

Melton has already started experimenting with human cells in the laboratory and hopes to start planning the first studies involving people with diabetes within a year. "I would say within five years we could be ready to start human trials," Melton said.

Other scientists have already started trying the approach on other cells, including those that could be used to treat spinal cord injuries and neurogenerative disorders such as Lou Gehrig's disease.

"The idea to be able to reprogram one adult neuron type into another for repair in the nervous system is very exciting," said Paola Arlotta, who is working in the Center for Regenerative Medicine at the Massachusetts General Hospital-Harvard Medical School, in Boston.

The research is the latest development in the explosive field of "regenerative medicine," which is trying to create replacement tissues and body parts tailored to patients. That dream appeared within reach after scientists discovered human embryonic stem cells, which can develop into any type of cell in the body. But stem cell research has been plagued by political and ethical debates because the cells can only be obtained by destroying embryos, which has been opposed by President Bush and others who believe that even the earliest stages of human life have moral standing.

Scientists last year shocked the field when they announced they had discovered how to manipulate the genes of adult cells to turn them back into the equivalent of embryonic cells -- entities dubbed "induced pluripotent stem" or "iPS" cells -- which could then be coaxed into any type of cell in the body.

The new work takes further advantage of the increasing prowess scientists have developed in harnessing the once mysterious inner workings of cells -- this time to skip the intermediary step of iPS cells and directly transform adult cells.

"This experiment proves you don't have to go all the way back to an embryonic state," Daley said. "You can use a related cell. That may be easier to do and more practical to do."

Doerflinger argued that the discovery was the latest evidence that research involving human embryos was no longer necessary.

"This adds to the large and growing list of studies helping to make embryonic stem cells irrelevant to medical progress," Doerflinger wrote in an e-mail.

But other researchers disputed that, saying it remains unclear which approach will ultimately prove most useful.

"Embryonic stem cells offer a unique window in human disease and remain a key to the long-term progress of regenerative medicine," Melton said.

For their work, Melton and his colleagues systematically studied cells from the pancreas of adult mice, slowing winnowing the list of genes necessary to make a "beta" cell that produces insulin. After narrowing the candidate genes to nine, the researchers genetically engineered viruses known as adenoviruses to ferry the genes into other pancreatic cells, known as exocrine cells, which normally secrete enzymes to help digest food. That finally enabled the researchers to identify the three crucial genes needed take control of the rest of the cell's genes to convert an exocrine cell into a beta cell.

"It was a mixture of work, luck and guessing," Melton said. "We achieved a complete transformation, or re-purposing, of cells from one type to another. We were delighted."

When the scientists tried the approach on diabetic mice, the animals became able to control their blood sugar levels.

"It didn't cure the mouse, but they were able to reduce their blood sugar levels to near normal," Melton said.

Melton and others said it remains to be seen whether it will be necessary to use genetically engineered viruses, which could face obstacles getting regulatory approval because of concerns about unforeseen risks, or whether chemicals might be found to do the same thing.

If preliminary studies in the laboratory are promising, Melton said he might first try converting liver cells to insulin-producing pancreatic cells because that would be safer than the pancreas. An alternative strategy would be to use the approach to grow beta cells in the laboratory and transplant them into patients.

Lanza said he was optimistic.

"One day, this may allow the doctor to replace the scalpel with a sort of genetic surgery," Lanza said. "If this can be perfected, it would represent one of the Holy Grails of medicine."

Tuesday, August 19, 2008

About New York - One Protest, 52 Arrests and a $2 Million Payout - NYTimes.com

About New York - One Protest, 52 Arrests and a $2 Million Payout - NYTimes.com: "One Protest, 52 Arrests and a $2 Million Payout

One Protest, 52 Arrests and a $2 Million Payout

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By JIM DWYER
Published: August 19, 2008

The city has agreed to pay $2,007,000 to end a lawsuit brought by 52 people who were swept up in a mass arrest along a Midtown sidewalk during a protest against the invasion of Iraq.

They were charged with blocking pedestrians, but videotapes show that at their most annoying, they might have slowed a few people carrying coffee into work. Public order did not seem to be in unusual danger that morning — certainly nothing that called for rounding up 52 people, or spending millions of dollars.

Only two people were tried; they were acquitted, and charges against the other 50 were dismissed.

The arrests were made on April 7, 2003, during the opening days of the invasion of Iraq and right after the city persuaded the Republican Party to hold its 2004 convention in New York. The people arrested said their rights to free speech had been abused, and sued the city and the police.

Now, five years later, the $2 million settlement is only part of the bonfire of legal expenses. And only some of the costs from this episode involve money.

Of the $2 million paid to the people who were arrested, $1,057,000 is for legal fees and expenses owed to their lawyers. The Law Department could not provide an estimate on Tuesday of how much it spent on the defense, said Laura Postiglione, a spokesman for Michael A. Cardozo, the city’s chief lawyer.

Just about every Tuesday and Thursday for over a year, witnesses were deposed under oath, part of the pretrial process in civil cases, according to Sarah Netburn, a lawyer with the firm Emery Celli Brinkerhoff Abady, which, along with the Center for Constitutional Rights, represented many of the people arrested that morning. The deposition transcripts cost over $100,000, said Matthew Brinkerhoff, another lawyer for the plaintiffs.

Among those deposed were 55 police officers and their supervisors. Between preparation and testimony, many would have lost two days of regular police work.

The city had five lawyers handling the case over the last four years, along with a special appellate team. A conservative estimate is that the city spent $1 million on the defense, including the salaries and benefits of police officers and lawyers, before running up the white flag.

“Although defendants believe that they would ultimately have prevailed at a trial, the costs of going forward weighed in favor of a settlement at this time,” said Susan Halatyn, a city lawyer.

But why were the arrests made in the first place?

That morning, two groups gathered on West 56th Street, outside the offices of an affiliate of the Carlyle Group, a private equity firm that has holdings in defense industries and employs many world figures, including the first President Bush.

One group of about 10 people planned to commit civil disobedience by sitting in front of the building, on the south side of 56th Street. The other group, of about 100 people, stood on the north side of the street, chanting.

Sarah Kunstler, 31, a lawyer, a filmmaker and the daughter of the renowned lawyer, said she had gone to see if there were possibilities of making a film about war protests. “I found out I could get arrested for absolutely no reason,” Ms. Kunstler said.

A film editor, Ahmad Shirazi, 70, said he was in the group on the north side of the street and had just finished speaking with reporters for the BBC when he saw officers beginning to mass.

“All of a sudden, from the Fifth Avenue side, a huge number of police officers entered 56th Street,” Mr. Shirazi said. “The protest was on the south side of the street. We were standing on the north side of the street. They came directly to us, they were in riot gear, and they surrounded us. They made a semicircle around us, shoulder to shoulder, with their batons.”

“Then they started arresting us, one by one. At that point, I got emotional — I could not believe in my country, in my city, I could get arrested for doing absolutely nothing and standing on the sidewalk,” Mr. Shirazi added.

Are there any lessons from the day? The Law Department said the $2 million payout did not mean the police had done anything wrong. “This settlement was reached without any admission of liability on behalf of the city and the individual defendants,” said Ms. Halatyn, the city lawyer.

The Police Department did not respond to a request for comment on the settlement.

Mr. Shirazi said that as he was being handcuffed for the first time in his life, he told the officer that the plastic cuffs were squeezing him. “He said, ‘You should have thought about that before you came out this morning.’ It was like a dagger in my heart, that a police officer of my city would come up with anything like that.”

E-mail: dwyer@nytimes.com

Pastor Rick's Test

Pastor Rick's Test: "Pastor Rick's Test
The Candidates Submit, and a Principle Suffers

By Kathleen Parker
Wednesday, August 20, 2008; A15

Pastor Rick's Test
The Candidates Submit, and a Principle Suffers

By Kathleen Parker
Wednesday, August 20, 2008; A15

At the risk of heresy, let it be said that setting up the two presidential candidates for religious interrogation by an evangelical minister -- no matter how beloved -- is supremely wrong.

It is also un-American.

For the past several days, since mega-pastor Rick Warren interviewed Barack Obama and John McCain at his Saddleback Church, most political debate has focused on who won.

Was it the nuanced, thoughtful Obama, who may have convinced a few more skeptics that he isn't a Muslim? Or was it the direct, confident McCain, who breezes through town-hall-style meetings the way Obama sinks three-pointers from the back court?

The candidates' usual supporters felt validated in their choices. McCain convinced and comforted with characteristic certitude those who are most at ease with certitude; Obama convinced and comforted with his characteristic intellectual ambivalence those who are most at ease with ambivalence.

The winner, of course, was Warren, who has managed to position himself as political arbiter in a nation founded on the separation of church and state.

The loser was America.

In his enormously successful book "The Purpose-Driven Life," Warren begins: "It's not about you." Agreed. Nor is this criticism aimed at Christians, evangelicals, other believers or nonbelievers -- or at Warren, who is a good man with an exemplary record of selfless works. Few have walked the walk with as much determination or success.

This is about higher principles that are compromised every time we pretend we're not applying a religious test when we're really applying a religious test.

It is true that no one was forced to participate in the Saddleback Civil Forum on the Presidency and that both McCain and Obama are free agents. Warren has a right to invite whomever he wishes to his church and to ask them whatever they're willing to answer.

His format and questions were interesting and the answers more revealing than what the usual debate menu provides. But does it not seem just a little bit odd to have McCain and Obama chatting individually with a preacher in a public forum about their positions on evil and their relationship with Jesus Christ?

The past few decades of public confession and Oprah-style therapy have prepared us perfectly for a televangelist probing politicians about their moral failings. Warren's Q&A wasn't an inquisition exactly, but viewers would be justified in squirming.

What is the right answer, after all? What happens to the one who gets evil wrong? What's a proper relationship with Jesus? What's next? Interrogations by rabbis, priests and imams? What candidate would dare decline on the basis of mere principle?

Both Obama and McCain gave "good" answers, but that's not the point. They shouldn't have been asked. Is the American electorate now better prepared to cast votes knowing that Obama believes that "Jesus Christ died for my sins and I am redeemed through him," or that McCain feels that he is "saved and forgiven"?

What does that mean, anyway? What does it prove? Nothing except that these men are willing to say whatever they must -- and what most Americans personally feel is no one's business -- to win the highest office.

Warren tried to defuse criticism about staging the interviews in his church by saying that though "we" believe in the separation of church and state, "we" don't believe in the separation of faith and politics. Faith, he said, "is just a worldview, and everybody has some kind of worldview. It's important to know what they are."

Presumably "we" refers to Warren's church of fellow evangelicals. And while, yes, everybody has some kind of worldview, it shouldn't be necessary in a pluralistic nation of secular laws to publicly define that view in Christian code.

For the moment, let's set aside our curiosity about what Jesus might do in a given circumstance and wonder what our Founding Fathers would have done at Saddleback Church. What would have happened to Thomas Jefferson if he had responded as he wrote in 1781:

"It does me no injury for my neighbor to say there are twenty gods, or no God. It neither picks my pocket nor breaks my leg."

Would the crowd at Saddleback have applauded and nodded through that one? Doubtful.

By today's new standard of pulpits in the public square, Jefferson -- the great advocate for religious freedom in America -- would have lost.

Kathleen Parker is syndicated by theWashington Post Writers Group. Her e-mail address iskparker@kparker.com.

Candidates' Abortion Views Not So Simple - washingtonpost.com

Candidates' Abortion Views Not So Simple - washingtonpost.com



Candidates' Abortion Views Not So Simple

By Jonathan Weisman
Washington Post Staff Writer
Wednesday, August 20, 2008; A01

The narrative of the presidential campaign appeared to be set on the issue of abortion: Sen. Barack Obama was the abortion-rights candidate who was reaching out to foes, seeking common ground and making inroads. Sen. John McCain was the abortion opponent whose reticence about faith and whose battles on campaign finance laws drew suspect glances from would-be supporters.

But both those impressions have been altered since the Rev. Rick Warren's Saddleback Civil Forum in California on Saturday.

Obama's hesitant statement at the forum that defining the beginning of life is "above my pay grade" took even some supporters by surprise. Since then, the National Right to Life Committee has challenged him on an obscure law that protects babies born alive after failed abortions, saying that his opposition to the measure in the Illinois state legislature proves he is an extremist.

McCain's performance at the forum seemed to hearten many conservatives, not only because of his firm, uncompromising stand against abortion but his broader appeals on global warming, genocide and the embrace of causes greater than self. But the clarity that McCain exhibited at Saddleback has been somewhat diminished with his suggestion that his running mate might favor abortion rights.

"Since Saturday night, I've seen a lot of confusion in the younger Christian voting bloc because they thought they had figured this thing out," said Cameron Strang, editor of Relevant magazine, which is aimed at a new generation of evangelicals. "There's no absolutely right candidate for an evangelical, and there's no absolutely wrong candidate. They're both right, and they're both wrong."

On paper, this campaign looks fairly standard. Obama, an Illinois Democrat, is staunchly in favor of abortion rights, while McCain, an Arizona Republican, has compiled a solid record over four Senate terms of opposing abortion.

But McCain has repeatedly been at odds with the National Right to Life Committee and other antiabortion groups over his efforts to limit their ability to run pointed "issue advocacy" advertisements in the closing weeks of campaigns. Although his voting record is strictly antiabortion, he has never made religiosity or social issues centerpieces of his political persona. And his 2000 labeling of evangelists Pat Robertson and the late Jerry Falwell as "agents of intolerance" deepened evangelical suspicions.

"To be perceived as authentic on this issue, you need to have some grounding in it, and usually that grounding is faith," said Douglas W. Kmiec, a Pepperdine University professor of constitutional law who opposes abortion but supports Obama.

As McCain moves toward naming a running mate, he has not backed off a suggestion to the conservative Weekly Standard that his pick could favor abortion rights. Speculation on whom that could be has centered on former Pennsylvania governor Tom Ridge and independent Sen. Joseph I. Lieberman of Connecticut.

Similarly, Obama has made a show of reaching out to abortion opponents to find common ground on pregnancy prevention and adoption. He has urged evangelicals and Catholics to expand the definition of "pro-life" to include opposing torture, poverty and unnecessary war. In the Democratic primary, Obama was criticized by Sen. Hillary Rodham Clinton's campaign and others for being insufficiently committed to abortion rights because he did not cast some votes on the issue in the Illinois legislature.

Abortion foes are now accusing Obama of being an abortion-rights extremist. In recent days, the National Right to Life Committee has charged that Obama is misrepresenting his record to broaden his appeal. At issue is a measure in both Illinois and Congress called the Born-Alive Infants Protection Act, which defines as a protected human any life expelled from a mother. Abortion foes championed the cause when an Illinois nurse and antiabortion activist said some pre-viable fetuses were being aborted by inducing labor and then being allowed to die.

Obama, then a state senator, opposed the measure in 2001, saying it crossed the line of constitutionality and "essentially says that a doctor is required to provide treatment to a pre-viable child, or fetus."

As a committee chairman in the state Senate in 2003, Obama supported GOP efforts to add language to the act, copied from federal legislation, clarifying that it would have no legal impact on the availability of abortions. Obama then opposed the bill's final passage. Since then, he has said he would have backed the bill as it was written and approved almost unanimously the year before.

Douglas Johnson, legislative director of the National Right to Life Committee, charged that Obama is trying to have it both ways because the Illinois bill he opposed was virtually identical to the federal law he said he would support.

Obama aides acknowledged yesterday that the wording of the state and federal bills was virtually identical. But, they added, the impact of a state law is different, because detailed abortion procedures and regulations are governed by states. Johnson and others are oversimplifying the situation, aides said.

"They have not been telling the truth," Obama told the Christian Broadcasting Network in response to a question on the matter. "And I hate to say that people are lying, but here's a situation where folks are lying."

At Saddleback, McCain won plaudits from conservatives when he said that life begins "at the moment of conception," especially after Obama deflected the question.

But the inroads McCain made are now threatened by his flirtation with a running mate who supports abortion rights.

"I think that the pro-life position is one of the important aspects or fundamentals of the Republican Party. And I also feel that -- and I'm not trying to equivocate here -- that Americans want us to work together," McCain told the Weekly Standard.

Conservative commentator David Limbaugh slammed the idea yesterday, warning that McCain "would make a fatal mistake to assume that social issues, especially abortion, are ever off an equally blazing front burner for an inestimable number of social conservatives."

Abortion remains an important issue to a large portion of the electorate, but it is not the biggest. An early August poll for Time magazine found that one in five likely voters would not consider voting for a candidate who did not share their views on abortion. Twenty-six percent of Republicans saw the issue as decisive, compared with 18 percent of Democrats.

Polling analyst Jennifer Agiesta contributed to this report.

Bloomberg Offers Windmill Plan - NYTimes.com

Bloomberg Offers Windmill Plan - NYTimes.com: "Bloomberg Offers Windmill Plan

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Bloomberg Offers Windmill Plan

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By MICHAEL BARBARO
Published: August 19, 2008

In a plan that would drastically remake New York City’s skyline and shores, Mayor Michael R. Bloomberg is seeking to put wind turbines on the city’s bridges and skyscrapers and in its waters as part of a wide-ranging push to develop renewable energy.

The plan, while still in its early stages, appears to be the boldest environmental proposal to date from the mayor, who has made energy efficiency a cornerstone of his administration.

Mr. Bloomberg said he would ask private companies and investors to study how windmills can be built across the city, with the aim of weaning it off the nation’s overtaxed power grid, which has produced several crippling blackouts in New York over the last decade.

Mr. Bloomberg did not specify which skyscrapers and bridges would be candidates for windmills, and city officials would need to work with property owners to identify the buildings that would best be able to hold the equipment.

But aides said that for offshore locations, the city was eyeing the generally windy coast off Queens, Brooklyn and Long Island for turbines that could generate 10 percent of the city’s electricity needs within 10 years.

“When it comes to producing clean power, we’re determined to make New York the No. 1 city in the nation,” Mr. Bloomberg said as he outlined his plans in a speech Tuesday night in Las Vegas, where a major conference on alternative energy is under way.

He later evoked the image of the Statue of Liberty’s torch, saying he imagined it one day “powered by an ocean wind farm.”

But the mayor’s proposal for wind power faces several serious obstacles: People are likely to oppose technologies that alter the appearance of their neighborhoods; wind-harnessing technology can be exceedingly expensive; and Mr. Bloomberg has less than 18 months left in office to put a plan into place.

Turning New York City into a major source of wind power would likely take years, if not decades, and could require a thicket of permits from state and federal agencies. Parts of New York’s coastline, for example, are controlled by the federal government, from which private companies must lease access.

Mr. Bloomberg is known for introducing ambitious proposals that later collapse, as did his congestion-pricing plan for Manhattan.

But aides said he was committed to developing alternative energy sources in the city, and wanted to jump-start the discussion now.

“In New York,” he said in his speech, “we don’t think of alternative power as something that we just import from other parts of the nation.”

Asserting the seriousness of his intentions, aides said, Mr. Bloomberg met privately with T. Boone Pickens, the oil baron who is trying to build the world’s largest wind farm in Texas, to discuss possibilities for such technology in New York.

And on Tuesday afternoon the city issued a formal request to companies around the country for proposals to build wind-, solar- and water-based energy sources in New York. “We want their best ideas for creating both small- and large-scale projects serving New Yorkers,” Mr. Bloomberg said.

Rohit Aggarwala, the director of the city’s Office of Long-Term Planning and Sustainability, said that turbines on buildings would likely be much smaller than offshore ones. Several companies are experimenting with models that look like eggbeaters, which the Bloomberg administration says could be integrated into the spires atop the city’s tall buildings. “”You can make them so small that people think they are part of the design,” Mr. Aggarwala said.

“If rooftop wind can make it anywhere, this is a great city,” he said. “We have a lot of tall buildings.”

Creating an offshore wind farm, he said, requires “pretty much the same level of difficulty as drilling an oil rig, but you don’t have to pump oil.”

“You could imagine going as much as 15, 20, 25 miles offshore, where it’s virtually invisible to land,” he said.

Mr. Aggarwala said that developing renewable energy for New York would take considerable time. “Nobody is going to see a wind farm off the coast of Queens in the next year,” he said.

But “the idea of renewable power in and around New York City is very realistic,” he said. “The question is what type makes the most sense and in what time frame. That is what we are trying to figure out.”

The city has experimented with wind power before. It put a turbine on city-owned land at 34th Street and the East River several years ago, but found that the technology was not efficient enough to expand.

The mayor’s plan includes the widespread use of solar panels, possibly on the roofs of public and private buildings. One proposal is to allow companies to rent roofs for solar panels and sell the energy they harvest to residents.

The city is already using tidal turbines under the East River that provide energy to Roosevelt Island. That technology could be widely expanded under the mayor’s proposal.

Beijing Beat: A Blog of the 2008 Olympic Games : What Chinese Stars Like Liu Xiang Earn From Sport

Beijing Beat: A Blog of the 2008 Olympic Games : What Chinese Stars Like Liu Xiang Earn From Sport: "What Chinese Stars Like Liu Xiang Earn From Sport
Tuesday, August 19, 2008 11:44 AM
By Newsweek

What Chinese Stars Like Liu Xiang Earn From Sport
Tuesday, August 19, 2008 11:44 AM
By Newsweek

The injury that cost Liu Xiang his chance to defend his Olympic gold in Beijing is likely to cost the Chinese hurdle star financially as well. It is unclear how much the athlete will lose in terms of endorsements and ad revenue, but what is clear is that his earnings show just how much China has changed over the years. Olympic stars who once could not have expected to make a living from their sports are now finding that there is money to be made from their prowess--but that bureaucracy often takes a cut, too. NEWSWEEK’s Chinese-language partner, Newsweek Select, takes a look at how fame has brought fortune to some of the nation’s stars.

By Diao Ying
NEWSWEEK SELECT IN CHINA

Xu Haifeng was the first Chinese to win an Olympic gold medal. That was in the 1984 free pistol shot competition in Los Angeles, and it earned Xu the first national prize money for an Olympic champion--9,000 RMB (about $1,312) and a salary increase from 51.5 RMB ($7.50) to 98 RMB ($14) per month. "At that time, that was already considered a lot of money," says Xu, now the deputy director of China’s Cycling and Fencing Sports Administrative Center.

No longer. While Xu Haifeng might have been one of the first athletes to make any money out of his sport, China’s top-earning athlete is now NBA star Yao Ming, whose estimated income for 2007 was 380 million RMB ($55.4 million). The country’s second biggest earner is Shanghai’s Liu Xiang, whose 2004 Olympic gold medal in the 110-meter hurdles earned him 160 million RMB (about $23 million) last year. Both are beneficiaries of China’s changing economic system. Wei Jizhong, a consultant to the Beijing Olympic Organizing Committee, and former national sports official who led the women's volleyball team to five consecutive championships, points out that during Xu Haifeng's era, people around the country were still discussing whether or not China should adopt a free-market economic system, not the commercialization of sports. "Xu Haifeng won in 1984, but the formal decision to adopt a market economy was made after [former Communist Party leader] Deng Xiaoping's 1992 southern tour," says Wei.

The changing stakes have led to changing attitudes too. While older athletes saw their sports as more about the glory of themselves and their nation, the new generation has learned the value of packaging itself. One example of an athlete ‘on message’ is Liu Xiang as spokesman for Amway’s nutrition supplement Nutrilite. At one press conference for the brand, Liu Xiang’s first comment was a plug for the brand. "It's been my dream to represent Amway,” he said as he took his seat. “From a young age, I used Amway products my father's work unit gave to him and felt they were great." When a journalist asked about Liu's dreams for the future, the athlete did not speak about hurdles or life, but instead resolutely said, "I hope everyone will use Nutrilite."
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Olympic medals don’t always bring in the money. Lu Hao, a high profile sports agent whose clients include Yao Ming, says that athletes’ market values are closely related to their media exposure and the type of sport they play. That’s why the gorgeous young athletes on the national badminton team--featured last year on a magazine cover that presented them dressed like Hollywood stars--have signed contracts with Federal Express, Bank of China, Pepsi and L’Oreal. The Chinese Ping-Pong team, by contrast, lags behind in these deals, in spite of its excellent match performances.

Most athletes, also, are still managed by state organizations. While sports like basketball and soccer are more commercialized than others, most still fall under a system called Sports for the Nation, where the value of an athlete’s brand falls largely under the domain of “state assets”. Yao Ming, who moved abroad to play, has an international team of professional money managers. Liu Xiang's "state owned" business activities, on the other hand, are managed by the Chinese Athletics Association. Intermediary organizations must pass through the Association to discuss advertising representative business. Under the state-owned athletic system, athletes' advertising earnings are allocated by provisions of China’s State General Administration of Sport. Accordingly, Liu Xiang keeps 50 percent of his earnings, with 15 percent going to his coach Sun Haiping, and 20 percent to his hometown Shanghai's sports bureau. The remaining 15 percent is allocated to the Chinese Athletics Association. Although there isn't a vast difference between the number of ads done by Yao Ming and Liu Xiang, the hurdle star’s income is less than half of the basketball star. “Yao Ming is already a professional athlete,” says Wei. “He only participates in national training for a short time when there's to be a match. Under the national system, athletes receive government subsidy and are financially taken care of by the state. So they don't entirely answer to themselves."

Chinese athletes who disobey the rules can pay a heavy price. In 2005, Sydney Olympic diving champion Tian Liang was removed from the Olympic team for participating in too many commercial events. The decision forced Tian out of the Beijing Olympics and also saw the sponsorships for the former “Sunshine Boy” fade into the twilight.

The next generation of sports stars is likely to be even savvier about marketing their achievements. Where Yao Ming’s parents refused to let him go to sports school because they felt he would not be able to make a living from his athleticism, parents like Ding Wenjun are now making enormous financial sacrifices to promote their children’s talent. Ding is the father of snooker player Ding Junhui, winner of the 2005 World Snooker China Open and the world’s Number 11 ranked player. Ding Wenjun, a former cigarette salesman, risked ruin by selling his family’s house to support his son’s career. The gamble paid off. Last year, the 21-year-old champion made 4.8 million RMB (almost $700,000) in ad and endorsement money--more than 500 times the award money Xu Haifeng received back in 1984.

Stem Cells and Breast Surgery - WSJ.com

Stem Cells and Breast Surgery - WSJ.com: "Stem Cells and Breast Surgery
New Procedure Uses Fat to Augment Women,
but Some Are Wary of Effects
By RHONDA L. RUNDLE
August 19, 2008

Yokohama, Japan

Stem Cells and Breast Surgery
New Procedure Uses Fat to Augment Women,
but Some Are Wary of Effects
By RHONDA L. RUNDLE
August 19, 2008

Yokohama, Japan

Researchers around the world are seeking ways to regenerate damaged hearts, spines and skin with stem cells. At an operating table here recently, Kotaro Yoshimura leaned over a 51-year-old woman and put stem cells to use for a different purpose: cosmetic breast surgery.
[popular procedure]

Dr. Yoshimura jabbed the underside of the woman's left breast with a thick, long needle, drawing it in and out. At his side, an assistant slowly cranked the handle of a canister filled with an orange-colored mixture, pumping it into the needle through a tube. The substance was a fat concoction from the woman's own body -- which had been processed in an adjoining laboratory to fortify the stem cells it contained. Then it was injected into the patient to enlarge her breasts.

The combination of fat and stem cells -- used to either make breasts larger or repair them after cancer surgery -- has become one of the hottest, and most controversial, corners of cosmetic medicine. Breast surgeries that rely on a person's own fat are being performed in Japan and Europe and are hurtling toward the U.S., where some surgeons are already experimenting.

The "genie is out of the bottle," says Grant Carlson, a plastic surgeon and surgical oncologist at Emory University in Atlanta. He worries that commercialization of the procedure is moving too fast, before data are collected about long-term consequences.

This is uncharted territory for the U.S. Food and Drug Administration, which regulates products and devices but not procedures. However, the FDA says fat augmented with stem cells creates a "biologic product" that would require regulatory approval.

The surgery relies on an old idea: the use of human fat to make a woman's breasts larger. Attempts to use fat transplantations in such a way date back more than a century, but they usually failed because most of the fat grafted onto the breast died, turning into hard lumps or calcifications. The concept has long been frowned upon in the U.S., although fat transfer has been used with limited success in other parts of the body.

Now, surgeons are returning to the idea, spurred by the discovery over a decade ago that fat contains a rich supply of cells similar to the stem cells found in bone marrow.

Using Fat as a Cosmetic Tool

A stem cell is a cell from which other types of cells develop. The theory behind the new procedures is that fat may be processed or handled in a way that allows fragile stem cells to create a blood supply for the transplant that helps the fat survive. During a single operation, fat is siphoned from a woman's thigh or abdomen and then processed using various techniques. The fat is injected back into the breasts. Because the patient is the donor, there is no risk of tissue rejection.

Harvesting stem cells from fat doesn't present the ethical issues that arise when stem cells are retrieved from human embryos. In fact, fat is routinely discarded by plastic surgeons after liposuction, one of the most popular cosmetic procedures. Research is increasingly looking into the therapeutic potential of adult stem cells taken from blood, bone marrow or fat.

The possibility of creating soft, natural-looking breasts has incited interest among cosmetic surgeons. Artificial implants, filled with saline or silicone gel, can rupture, and some say they don't look natural. A small San Diego company, Cytori Therapeutics Inc., says it has invented a machine that combines fat with a mixture of stem cells and other regenerative cells. The device is being used by some hospitals in Europe and Japan. Cytori is sponsoring human tests in Europe and talking to the FDA about similar efforts in the U.S.

Some doctors worry the fat, when reinjected in the breast, could calcify and interfere with mammographic cancer screening. Another concern is that fat injections could increase the risk of breast cancer, because certain anticancer drugs work in postmenopausal women by inhibiting the production of estrogen, a hormone in fat tissue.

Regardless, some U.S. surgeons are showing before-and-after pictures of breasts they have enlarged, reshaped or repaired using fat grafting. There is no proven technique, but some surgeons say they have been encouraged to experiment after successfully grafting fat to other parts of the body, including faces and hands.

Jafar Koupaie, a cosmetic surgeon in Brookline, Mass., says he performed breast surgeries on two women April 1, using a Korean cell-processing device. He says he is using a patient's own cells and isn't adding anything from outside the human body. One of the patients, he says, was his wife.

The FDA says it has only sketchy details about Dr. Koupaie's procedure. "If you're mixing stem cells with fat cells, that requires FDA approval," said Karen Riley, an agency spokeswoman. When told of the FDA's comment, Dr. Koupaie said, "If they want more information, they can come and see we put only the patient's fat into the machine."

Sydney Coleman, a New York plastic surgeon, published a breast study last year about fat grafting in Plastic and Reconstructive Surgery, a medical journal. He has been grafting fat to the breast, without adding a stem-cell mixture, for many years, although other doctors have had difficulty adopting his technique. Cytori has begun working with plastic surgeons in Japan, Israel, Italy and France who are using its device.

Even the medical establishment is revisiting the issue: The American Society for Aesthetic Plastic Surgery's research arm is funding a breast-augmentation study. Patients are being recruited at ClinicalTrials.gov.

The cost of fat-grafting procedures for cosmetic breast surgery ranges widely, from $15,000 to $30,000 or more depending on the surgeon and clinic.

Fat transplantation "has moved into center stage from the backroom," says Scott Spear, a plastic surgeon at Georgetown University in Washington, D.C., who is conducting the study. He says he hopes it will validate the safety and efficacy of fat grafting in the breast. But Dr. Spear says the study won't answer a key question: how much the processing of fat-derived stem cells contributes to the success of the surgery. It is possible that the transplanted fat alone contains enough stem cells to do the job, he says.

So far, neither Cytori nor Dr. Yoshimura -- who uses his own, manual process to supplement stem cells in fat -- has provided sufficient evidence to demonstrate that bolstering fat with more stem cells improves graft survival, Dr. Spear says. Dr. Yoshimura and Cytori, who are working separately, both say their studies are promising but agree more research is needed.

'Natural Looking Forever'

Dr. Yoshimura says he began testing his technique in patients in 2003. He has performed about 200 operations, mostly on Japanese women, but also on some from the U.S. and Canada. He operates on Saturdays out of the luxurious, wood-paneled Cellport Clinic in the Tokyo suburb of Yokohama.

The clinic, which includes a cell-processing laboratory, was built two years ago at a cost of $26 million by Japan's Biomaster Inc. The venture-capital-backed company's chairman, Ryuji Kuwana, says he is talking with potential partners about constructing similar clinics outside Japan.

Dr. Yoshimura, who calls his operation "cell-assisted lipotransfer," starts with a liposuction procedure to obtain fat, typically from a woman's thigh. He divides the fat in two: Half is processed through a centrifuge, yielding a concentrated stem-cell mixture that is then recombined with the other half. The cell-supplemented graft is delivered through a syringe at four injection sites into the breast. The surgery takes three to four hours, he says.

Like other surgeons who perform fat-transfer procedures, he can't predict exactly how much of a graft will survive, but says most of the tissue volume stabilizes within three months. Dr. Yoshimura says his average graft survival rate is 54%. That makes it difficult to give a woman an augmentation of more than one bra-cup size, from an "A" to a "B," for instance. But the procedure can be repeated. A handful of Dr. Yoshimura's patients have returned for a second augmentation surgery. One Canadian woman says she paid about $20,000 for the first operation and $15,000 for the second.

Such surgeries are also being done at two other clinics in Japan, the Seishin Cosmetic Clinic in Tokyo and Kyushu Central Hospital in Fukuoka. Surgeons at both places process stem cells using the machine developed by Cytori.

By automating the cell-processing procedure at bedside during a surgery, Cytori hopes to make fat transplantation easier, faster and more predictable. It says it is aiming for a total procedure time of about one hour with new machines developed with its partner, Olympus Corp., the Japanese maker of cameras and medical equipment.

To tout its procedure, the Seishin clinic recently ran pictures of a bikini-clad woman showing how her natural bust was augmented by surgery. Speaking through a translator, the woman, Erika Igarashi, said in an interview she was unhappy about her flat chest and began researching Internet sites last fall. She found the Seishin clinic and volunteered. After a consultation, she stopped dieting to have enough body fat for the operation, which was performed Nov. 7. Ms. Igarashi said she didn't pay for the procedure.

When she woke up, she says, "I looked down and saw big breasts." She felt pain in her thighs where fat was harvested and her breasts initially felt "hard and heavy." Now, more than nine months later, her breasts are a bit smaller, but the size has stabilized, she says. Her new form gives her "lots of confidence," she says, adding she can wear "a greater variety of clothing," including low-cut dresses. The 22-year-old university graduate works part-time in a nightclub and is looking for a job in the cosmetics industry.

Cytori says it has invested about $100 million in researching and developing its device, which looks like a portable dishwasher and is priced between $75,000 and $100,000.

With commercialization moving ahead in Japan and Europe, Cytori is now taking aim at the U.S. It hopes the FDA will allow it to begin human tests with its device next year to reconstruct breasts damaged by cancer surgery. It has also retained Dr. Coleman, the New York surgeon, as a consultant. Cytori hopes its device will eventually be used to regenerate tissue for treating cardiovascular disease, orthopedic damage, gastrointestinal disorders and pelvic health conditions.

Write to Rhonda L. Rundle at rhonda.rundle@wsj.com
[stem cells]

Researchers produce blood in lab from stem cells - Los Angeles Times

Researchers produce blood in lab from stem cells - Los Angeles Times


Researchers produce blood in lab from stem cells
The discovery marks a technical advance but has a long way to go before it can be considered an alternative to donor blood.
By Karen Kaplan, Los Angeles Times Staff Writer
1:07 PM PDT, August 19, 2008
Scientists said today that they have devised a way to grow large quantities of blood in the lab using human embryonic stem cells, potentially making blood drives a relic of the past.

But experts cautioned that although it represented a significant technical advance, the new approach required several key improvements before it could be considered a realistic alternative to donor blood.

The research team outlined a four-step process for turning embryonic stem cells into red blood cells capable of carrying as much oxygen as normal blood. The procedure was published online in the journal Blood.

The ability to make blood in the lab would guarantee that hospitals and blood banks have access to an ample supply of all types of blood, including the rare AB-negative and O-negative, the universal donor.

It would also ensure that patients are never at risk of contracting diseases such as hepatitis C or HIV, which can be acquired from donor blood, said Dr. Dan Kaufman, associate director of the University of Minnesota's Stem Cell Institute, who wasn't involved in the study.

"People don't usually think about these types of cells when they talk about human embryonic stem cell therapy, but it is important," Kaufman said. "There's more infections all the time, and the number of donors is more and more limited."

Researchers have tried to harness the so-called adult stem cells that are responsible for making blood in the body, but their methods were far too inefficient to be put to practical use, experts said.

In the new study, researchers were able to make up to 100 billion red blood cells -- enough to fill two or three collection tubes -- from a single plate of embryonic stem cells.

After allowing the stem cells to begin the earliest stages of embryonic development, the researchers prompted some of them to grow into red blood cells by exposing them to a variety of proteins.

Up to 65% of the resulting cells matured to the point at which they shed their nucleus, which allows them to take on the distinctive doughnut shape of circulating red blood cells, said Dr. Robert Lanza, chief scientific officer at Advanced Cell Technology Inc. and the study's senior author. The team, which also included researchers from the University of Illinois at Chicago and the Mayo Clinic in Rochester, Minn., produced blood of types A-positive, A-negative, B-positive, B-negative and O-positive+.

The method was 100 times more efficient than previous efforts, said Eric Bouhassira, a professor of stem cell biology and regenerative medicine at Albert Einstein College of Medicine in New York. But most of the cells had embryonic or fetal versions of globin, the compound in red blood cells that carries oxygen. Only a relative handful appeared to contain the adult globin that would be needed by patients, he said.

"Whether they would be good enough for transfusion is very unclear," said Bouhassira, who was not involved in the research.

Lanza said the research team is conducting additional experiments to see whether the stem cells will produce more adult globin if given more time to mature in the lab.

Even with substantial improvements, the method faces another big hurdle.

Roger Dodd, vice president of research and development at the American Red Cross' Holland Laboratory in Rockville, Md., said producing blood in the lab could cost thousands of dollars per unit -- far too expensive to replace the 14 million pints of red blood cells that are transfused every year.

"It's a rather ambitious goal," Dodd said.

karen.kaplan@latimes.com