S. Korea to aid U.S. stem cell work
New research consortium also will include Britain

By Bruce Lieberman
U/T STAFF WRITER

October 19, 2005

Scientists in South Korea announced today that they'll help American biologists create new stem cell lines and accelerate research - an unprecedented partnership that sidesteps federal restrictions in the United States.

The resulting World Stem Cell Foundation, which includes Britain, will be led by South Korean researchers who have developed highly efficient ways to clone human embryos. The consortium's backers hope to rapidly expand the supply of embryonic stem cells that scientists can use to study cancer, Alzheimer's disease, Parkinson's disease, Lou Gehrig's disease and other illnesses.

Some of that work is expected to take place in San Diego, including projects at the University of California San Diego and The Burnham Institute.

"By overcoming a lot of the technical hurdles, (the Koreans) really have something to offer the international community," said Evan Snyder, a stem cell biologist at Burnham.

The collaboration brings together South Korea's government, South Korean stem cell pioneer Hwang Woo-suk and Pittsburgh biologist Gerald Schatten, the lead U.S. contact. It marks a bold and ambitious venture in a fledgling field. The funding would come from South Korea, private donations and possibly other sources.

The consortium plans to set up labs in the San Francisco Bay Area and England, where South Korean technicians would produce a total of about 100 stem cell lines per year. The lines each would be engineered to carry various genetic defects that trigger diseases. Participants in the United States and Britain would buy these stem cells to study the illnesses.

"When the use of these stem cells is limited to a particular country, it takes much too long to create technologies usable for the whole humanity," Hwang said before the announcement. "By creating a global network, we plan to share stem cells created in each country and share information on those stem cells."

Many details need to be worked out, including how much the consortium will charge scientists for the new stem cell lines, whether South Korean expertise will be shared with American and British scientists, and how the World Stem Cell Foundation will confront ethical issues related to creating embryos for research.

"I think it's generally a good idea," said Fred Gage, a stem cell researcher at the Salk Institute in La Jolla. "In the end, California and other countries will want to incorporate the (South Korean) technology within their own centers rather than have all the core work done somewhere else."

Scientists are eager to experiment with new human embryonic stem cells, which grow in an embryo to become every other cell in the body. Examining how stem cells develop could reveal much about basic biology and the genetics of disease.

To obtain stem cells for the lab, researchers must extract them from an embryo – typically one donated by a couple with embryos stored at a fertility clinic. The process destroys the embryo, so the field is controversial among people who regard an embryo as a human being. In 2001, President Bush halted federal funding for research that destroys human embryos for new stem cell lines.

In California, lawsuits have stalled a $3 billion initiative that voters passed last year to use state tax dollars for creating new stem cell lines and advancing the field.

Scientists continue to conduct stem cell research on animals and with stem cells taken from adult organs.

Many biologists insist there is no substitute for studying human embryonic stem cells. Batches of the cells already in labs when Bush issued his 2001 order have limited value – partly because they are contaminated – and new ones are needed, they said.

"The cells available are not up to the job, so many people are interested in developing new cells that will more accurately reflect the diseases they (study)," said Theodore Friedmann of UCSD, a gene therapy specialist who wants to participate in the new consortium to explore a rare childhood disease called Lesch-Nyhan. The genetic disorder causes mental retardation and a host of other medical problems.

While embryonic stem cell research is restricted in the United States, such studies in South Korea have progressed without government opposition. Hwang and his colleagues have generated batches of stem cells with unrivaled success rates by refining a technique called somatic cell nuclear transfer. In the procedure, scientists clone a person's DNA by placing it inside a fertilized egg taken from a different individual. That egg had its own DNA removed earlier.

By joining the egg and the donated DNA, biologists are able to create an embryo that quickly produces stem cells. Those cells have the same genetic code as the person who donated the DNA.

Somatic cell nuclear transfer has two main advantages, scientists say. First, researchers can generate stem cells that are compatible with the people who donated their DNA. Theoretically, such cells could be used as replacement tissue for the donors if, for example, they suffer a spinal cord injury or degenerative disease.

Second, scientists hope to generate human embryonic stem cells with specific genetic defects. If people who donate their DNA have Parkinson's disease, for instance, the resulting stem cells will show Parkinson's. Through lab work, biologists then would chart how the disease progresses as the stem cells develop into brain cells.

The same approach could apply for the Lesch-Nyhan condition studied by UCSD's Friedmann.

"What we need to do now is to look and see what goes on early on – when a stem cell decides to become a brain cell – and what goes on when this genetic defect prevents it from doing it faithfully," Friedmann said.

The overall desire for stem cell scientists to advance their work despite government restrictions is great, said Schatten, the Pittsburgh researcher.

"In order to move forward, we scientists need some kind of safe haven," he said in a commentary released today in the New England Journal of Medicine.

The Associated Press contributed to this report.

Embryonic state - Committee sorting out ethics (issues) of California's stem cell research program moving slowly

By Sandi Dolbee
RELIGION & ETHICS EDITOR

October 20, 2005

Anyone with children knows what that first year brings. Learning to crawl. Gingerly standing up. Trying to walk. The same goes for tackling the ethics issues of California's fledgling, embryonic stem cell venture.

Nearly a year after voters authorized a $3 billion investment for stem cell research in this state, the committee formed to sort out the ethical and medical details have only taken baby steps.

"Not a whole lot has been done," acknowledged Ted Peters, a Lutheran theologian and bioethicist from the Graduate Theological Union in Berkeley who serves on the Scientific and Medical Accountability Standards Working Group.

"I am happy with the working group," said Peters, who is putting together a book about stem cell ethics. "It's just slow. That's not a criticism. It's just slow."

Under Proposition 71, approved last November by 59 percent of the voters, the standards working group is made up of ethicists, patient advocates and scientists.

The group is one of three advisory panels who make recommendations about various issues to the Independent Citizens' Oversight Committee, the governing board for the California Institute for Regenerative Medicine, the agency created to decide which state universities and research programs will get the money.

If the bureaucracy sounds dull, the prospects are hot stuff – finding a way to use unprogrammed stem cells extracted from embryos to heal diseased organs and injured bodies.

But the devil is in the details. Which diseases will be researched first? How will scientists share their state-funded discoveries? What guarantees are there that donors and patients will be informed and protected? Who profits? And what about teaming up with other states or other countries who aren't under California's rules?

"A year ago, I think the issue was, do we really want embryonic stem cell research to go forward," said Dr. Bernard Lo, a medical ethicist at the University of California San Francisco and co-chair of the standards working group.

Now, Lo added, "it's time to look ahead to clinical trials, to how we're going to use this in implantation."

The standards working group has only met twice – in July and August. After that second meeting, it was decided that the staff needed to get more information about state and federal requirements.

"In the end, it was felt that it was best for the staff to really pull together, to take some time and do some homework," said Geoff Lomax, who was hired in August to be the institute's staff liaison to the standards working group.

"I've never known a committee of this nature, where everyone can literally parachute into the room and suddenly make great leaps and strides," Lomax said from the institute's San Francisco headquarters.

"It takes a bit of time. I think baby steps are just fine."

The pace is about to pick up significantly.

The institute has interim guidelines for embryonic stem cell research, based on those issued last spring by the National Academy of Sciences. The 11-page document prohibits stem cells from being taken from embryos more than 12 days old (not counting the time they've been frozen in storage), requires grant recipients to have internal review boards, denies payment to donors for their embryos or eggs, and talks about setting up a stem cell bank accessible to state-funded investigators.

However, between now and the end of January, Lomax said the standards working group will be honing the guidelines. Beginning next week, the group will meet three times – Oct. 24 in Los Angeles, Dec. 1 in San Francisco and Jan. 30-31 in Los Angeles – in an effort to have the final recommendations to the oversight board in February.

Among the 15 members currently on the working group are three bioethicist representatives – Lo, Peters and R. Alta Charo from the University of Wisconsin-Madison. Patricia King of Georgetown University is expected to become the fourth bioethicist, after her nomination is confirmed by the citizens' oversight committee next month.

"I don't think we're talking about re-inventing or creating something from nothing," Lomax cautioned. "What we're really looking at is building upon an established tradition of effective research oversight in California. What I think the guidelines are really going to emphasize is what needs to be done in addition to what we believe is already good practice in California."

Minding the gaps

Jesse Reynolds is among the observers who would like to see the standards working group develop more specific rules and safeguards.

"The guidelines by the national academy have some significant gaps and holes in them," said Reynolds, who works for the Center for Genetics and Society, an advocacy and watchdog group in Oakland.

In a separate report issued in September by UCSF's own advisory committee on stem cell research, Lo and a team of colleagues also argued for stronger guidelines in preparation for clinical trials – when and if they happen.

At the top of their concerns: ensuring that the health of donors be tracked, that their confidentiality be guarded and that prospective patients understand the purpose of early trials is more about determining the safety of the therapy than producing cures.

Lo worries that not enough is known about the medical history of the men and women who will be donating leftover embryos from IVF procedures. Some of those spare embryos may have been frozen in storage for years, and before their cells are implanted into another person, complete medical histories need to be taken from the donors. There also need to be follow-up checks in case a disease emerges that may also be coded in those embryonic cells.

"We have to protect those recipients from acquiring genetic diseases or infections," he said.

Steps also need to be taken to ensure confidentiality and privacy. "So we need to be able to go back, they need to agree to that, and we need to assure protection for them," Lo said.

Peters, the only theologian on the working group, raises economic justice questions, like how the poor and uninsured will get whatever therapy is developed. "I don't know yet how we are going from research to product to distribution," he said.

Reynolds warns that an ethical lapse could have dire consequences.

"If there's a headline that says a cloned embryo created with Proposition 71 has been sent to Nevada and implanted in a woman and now there's a clone, or a scandal that says a research facility in California has been caught buying eggs on the international market ... it will just shatter public support for the California stem cell research program," he said.

Lo, for one, said he knows what's at stake.

"This is public money. The public gave us a lot of responsibility," he said. "To do something that flies in the face of thoughtful public opinion would be extremely unwise. It would make the public very cynical about scientists."

Money for research has yet to flow
Many contend issue is still not settled

SANDI DOLBEE
UNION TRIBUNE

October 20, 2005

While Proposition 71 was supposed to turn on the state spigot to counter the federal drought, court challenges have blocked funding - at least for now.

The battle of words isn't settled, either.

"I would stake my entire professional life on the fact that life begins at fertilization," said Dr. William Hurlbut, a physician and ethicist at Stanford University who also serves on the President's Council on Bioethics.

Hurlbut opposes embryonic stem cell research on moral grounds, because the days-old embryos are destroyed by the process of extracting the cells. He is pushing funding for alternative research that would alter eggs in such a way that they would produce unprogrammed stem cells without becoming living beings.

He and another member of President Bush's advisory council gave cautious, if not condemning, appraisals of embryonic stem cell research at a symposium earlier this month at First United Methodist Church in Mission Valley.

While Hurlbut refused to say how he voted on Proposition 71, his colleague said if she lived here, she would have voted against the $3 billion stem cell initiative approved by California voters last November.

"I think it's a misallocation of resources," said Rebecca Dresser, who teaches ethics to legal and medical students at Washington University in St. Louis.

Dresser, who described herself as a liberal Democrat, would rather the $3 billion be spent on providing basic health care to everyone.

Another concern is the hype. "People think it's going to cure everything – even cancer," she said.

The Oct. 8 program was sponsored by the church's San Diego School of Christian Studies, along with a local consortium called the Center for Ethics in Science and Technology and the Values Institute at the University of San Diego.

Michael Kalichman, who heads the research ethics program at UCSD and helped start the local ethics consortium, said listening to Dresser and Hurlbut reminded him that a "significant minority" opposes this science for a variety of reasons.

Meanwhile, Congress is threatening to expand funding, and Bush is vowing to veto any such effort.

As Kalichman puts it, "Even though we approved this in California, we are still a very divided society."

Stem cell transplants to treat children's neural disease get OK

ASSOCIATED PRESS

October 21, 2005

SAN FRANCISCO - Federal regulators yesterday approved what would be the first transplanting of fetal stem cells into human brains, a procedure that if successful could open the door to treating a host of neural disorders.

The transplant recipients will be children who suffer from a rare, fatal genetic disorder.

The Food and Drug Administration said doctors at Stanford University Medical Center can begin the testing on six children afflicted with Batten disease, a degenerative malady that renders its young victims blind, speechless and paralyzed before it kills them.

The stem cells to be transplanted in the brain are immature neural cells that are destined to turn into the mature cells that make up a fully formed brain.

Parkinson's disease patients and stroke victims have received transplants of fully formed brain cells before, but the malleable brain cells involved in this case have never been implanted.

Batten disease is caused by a defective gene that fails to create an enzyme needed in the brain to help dispose of brain cellular waste. The waste piles up and kills healthy cells until the patient dies. Most victims die before they reach their teens.

The idea is to inject the sick children with healthy, immature neural stem cells that will "engraft" in their brains, which will direct the cells to turn into those able to produce the missing enzyme.

Such an experiment showed promise in Batten-afflicted mice, but such an ethically charged test has never been tried in humans.

"I'm sure there is no threat to anyone's identity," said Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics. "But we are starting down that road."

What's more, some of the brain cells to be implanted will be derived from aborted fetuses, which Caplan said raised ethical concerns for some.

Stem Cells Inc., the Palo Alto biotechnology company developing the Batten disease treatment, said it receives its fetal tissue from a nonprofit California foundation that also collects tissue from miscarriages and other surgical processes. Stem Cells chief executive Martin McGlynn declined to identify the foundation.

Tragedies jog GOP shift on stem cells

By Dana Wilkie
COPLEY NEWS SERVICE

October 22, 2005

WASHINGTON - Rep. Jo Ann Emerson, R-Mo., who has repeatedly authored bills that would ban abortion, once told a wheelchair-using young man she could never support the stem cell research that he believed might one day help him walk.

But then her close friends had a baby with muscular dystrophy, her husband developed cancer and died, and her mother-in-law succumbed to dementia. The day after her mother-in-law's death in May, Emerson stood on the House floor and asked: "Do they not have as much right to life as that embryo that is going to be tossed away?"

Much political drama surrounds the Senate's consideration of a plan to ease the stem cell restrictions that President Bush imposed four years ago and yesterday it contributed to the decision to put off a vote until next year.

But perhaps more interesting are the personal stories that shed light on why some conservatives have defied their president on the issue of stem cell research.

"I think personal experiences make a huge difference on issues like this," said Thomas Mann, a scholar at the Brookings Institution. "The promise of breakthroughs in research (on) Parkinson's disease or juvenile diabetes are sufficient for some pro-life politicians to support public funding of stem cell research."

Four years ago, Bush limited federally funded research to about 60 stem cell lines that already existed. After it became clear that fewer than two dozen were suitable for research, advocates began clamoring for fresh stem cell lines.

In a rare defeat for Bush, the House in May voted 238-194 to ease those restrictions, with the support of 50 Republicans. The Stem Cell Research Enhancement Act of 2005, or H.R. 810, would allow federally funded research on stem cells from fertility-clinic embryos that otherwise would be discarded. No federal money would go to scientists using embryos harvested solely for research.

Bush has threatened to veto the legislation.

Intense wrangling over the issue was only part of the reason the vote was put off; the Senate is grappling with hurricane relief, a Supreme Court confirmation and the federal budget. Observers count more than 50 senators who would support the bill and that situation would present Bush with a political dilemma: using the first veto of his presidency on an issue that has strong congressional and public support. But Senate backing isn't yet strong enough to override a veto; that takes 67 votes.

When he was diagnosed in February with Hodgkin's lymphoma, a cancer of the lymph glands, Pennsylvania Sen. Arlen Specter's support for stem cell research was already well known. Months of chemotherapy have solidified his resolve to persuade fellow Republicans to join his crusade. Also, last year Specter lost his 48-year-old chief of staff to breast cancer and a good friend was diagnosed with Parkinson's disease.

"I hate to personalize this, but when I look back at 1970 (when) President Nixon declared war on cancer, if that war had been adequately funded . . . I might not have Hodgkin's lymphoma cancer today," Specter said during a May appearance on ABC's "This Week with George Stephanopoulos."

Longtime abortion foe Bill Frist, the Senate majority leader from Tennessee, referenced his ethical responsibilities as a transplant surgeon when he announced this summer that he would break with Bush and support the House bill.

"I am a physician," Frist told his colleagues. "My profession is healing. I have devoted my life to attending to the needs of the sick and suffering. . . . In all forms of stem cell research, I see . . . great promise to heal."

Rep. Joe Barton, R-Texas, who has opposed abortion for all of his 21 years in Congress, said his support for stem cell research is based partly on family tragedies: His father died of complications from diabetes at 71, his brother died of liver cancer at 44, and his first granddaughter died in the womb because of a crimped umbilical cord.

Other prominent, anti-abortion Republicans who supported the House bill included Bakersfield Rep. Bill Thomas, who is chairman of the Ways and Means Committee, and Utah Sen. Orrin Hatch.

But other opponents of abortion haven't budged, arguing, as Bush has, that embryos not implanted in a uterus are living beings that should not be used for research.

Rep. Duncan Hunter, the only San Diego-area representative who voted against H.R. 810, said through a spokesman that "stem cell research has yielded little success and continues to demonstrate inherent biological problems that make treatment for human disease unlikely."

Hunter's four San Diego colleagues all voted for H.R. 810. Rep. Randy "Duke" Cunningham, R-Rancho Santa Fe, had a change of heart about such research after his own battle with prostate cancer. On the House floor in May, he nearly wept as he declared that he didn't "want another 6-year-old to die."

Gov. Arnold Schwarzenegger is perhaps the most well-known Republican to support stem cell research. Personal experiences, which he won't describe, influenced his decision, spokeswoman Margita Thompson said. But she said the biggest impetus was that "he wanted to search for cures to help people."

Schwarzenegger backed California's Proposition 71, a $3 billion initiative for stem cell research that voters passed in November.

Former first lady Nancy Reagan phoned wavering lawmakers just before May's House vote. She reportedly plans to do the same when the Senate votes. The late President Ronald Reagan suffered from Alzheimer's disease.

A 2002 Pew Research Center poll found that 43 percent of Americans said it was more important to conduct embryonic stem cell research than to protect embryos. In 2004, 56 percent of Americans felt this way, according to the center.

Still, conservatives such as Emerson say it was tough for them to break with Bush and with anti-abortion constituents.

"I have met with ethicists, scientists, two priests and my own minister to talk about this agonizing decision," said Emerson, who describes her anti-abortion voting record as "perfect."

Rep. Lane Evans, D-Ill., who has Parkinson's, acknowledged that "this is for many members a very intense issue because they're concerned about their political future.

"It was an act of courage for them . . . because they knew it might hurt them."

Stem cell work proceeds with caution

By Bruce Lieberman
UNION TRIBUNE

October 24, 2005

A single gene mutation causes Lesch-Nyhan syndrome. That one error can wreak havoc on children born with it, triggering mental retardation, muscle stiffness, uncontrollable writhing, kidney failure and a compulsion to violently gnaw on the lips, tongue and fingertips.

The disease may be a perfect candidate for stem cell research.

If scientists can engineer stem cells in the lab so they have the single gene defect, and then coax those stem cells into becoming brain cells, they might learn how this mutation causes the syndrome - and how to stop it.

"If we can understand what goes on in Lesch-Nyhan disease, we may be able to understand what goes on in Parkinson's disease," said Theodore Friedmann, a gene therapy expert at the University of California San Diego who has studied Lesch-Nyhan for years. The cause of Parkinson's is complex, but it leads to similar abnormalities in body movement.

Friedmann and other local researchers are part of the highly dynamic field of stem cell research. They and their colleagues worldwide have generated headlines in recent weeks.

Some are developing ways to take stem cells out of embryos without harming them, and one biologist announced some success this month. On Wednesday, South Korean scientists said they hope to form a partnership with U.S. and British counterparts – including Friedmann – to create new supplies of stem cells.

Despite the bold efforts, biologists acknowledge that stem cell work remains in its infancy.

"Stem cells are not pixie dust," said Evan Snyder, who directs the stem cell research division at the Burnham Institute in La Jolla. "You can't just sprinkle them into an area and think they know what to do."

To make long-term progress, Snyder said, scientists must learn not only how stem cells work, but also about the diseases modern medicine hopes to cure.

Contrary to how many people view stem cell research, the field involves much more than looking for ways to grow replacement cells for the brain, liver, spinal cord and so on. Just studying stem cells in the lab could reveal a lot about basic biology, such as how defective genes lead to disease.

Stem cell scientists must exercise caution as they move toward new clinical trials, Snyder said. The field cannot afford the harsh criticism that gene therapy has experienced since Jesse Gelsinger, 18, died six years ago during an experiment at the University of Pennsylvania.

In 2003, the Food and Drug Administration temporarily banned certain types of gene therapy trials, and the agency has not approved any gene therapy product for sale.

"We . . . don't want to fail and we can't afford to fail. Otherwise we'll end up like the gene therapy field, which has been in the scientific doghouse for a decade," Snyder said. "Stem cell work is too much a fundamental part of human biology to be relegated to sham science."

Technical aspects aside, the field has spawned many ethical and religious questions. One area of study, human embryonic stem cell research, is controversial because so far it requires destroying embryos.

President Bush, who perceives embryos as potential human lives, has shown no signs he will reverse his 2001 ban on federal funding for experiments that require destroying new embryos.

The U.S. Senate decided Friday to postpone, until next year, a debate about loosening Bush's restrictions. Meanwhile, lawsuits have tied up a California initiative to jump-start human embryonic stem cell research with $3 billion in state tax dollars.

In La Jolla, Evan Snyder said the field is consumed with two broad areas of inquiry:

1. What makes a stem cell a stem cell? What genes inside a stem cell's DNA give it the potential to become every tissue in the body? In addition, how can scientists maintain stem cells so they don't spontaneously develop into some type of tissue? And how can researchers prompt a stem cell to become a specific type of tissue?

2. What type of stem cell is best for treating a particular disease? "There's a whole smorgasbord of stem cells people can now use," including those in the brain, blood and pancreas, Snyder said.

"What cell is really best for what disease? That's a huge debate," Snyder said.

Each disease presents vastly different challenges, said Fred Levine, who studies the biology of diabetes at the Burnham Institute.

Researchers have become fairly adept at coaxing stem cells to become brain cells. But where do you put them in the brain to treat Alzheimer's, a degenerative condition that robs people of their memory?

"Unless you put it back into the brain in the precise location, and with hundreds or thousands of connections that an individual neuron can make, it's not going to function properly," Levine said.

For contrast, consider the treatment of diabetes. Biologists know they can put beta cells, which produce insulin, just about anywhere in the body, Levine said. These cells automatically sense blood glucose levels and secrete insulin as needed.

Engineering stem cells to become beta cells is a formidable job.

"It's turned out to be a real bear," Snyder said.

The Burnham Institute hopes to learn more about these and other challenges through a $3 million federal grant it received in August. The National Institutes of Health named Burnham an "Exploratory Center for Human Embryonic Stem Cell Research." The institute was one of three sites chosen nationwide.

The money will help scientists explore the most basic questions about stem cells, such as how genes control a stem cell and how molecules in a stem cell move around and change the cell's function.

Human embryonic stem cells offer biologists a direct view into human biology. That might sound obvious, scientists say, but much of basic medical research has been conducted on animals.

"We use animals to test ideas and develop ideas, but animals aren't people. There are many differences," said Larry Goldstein, a stem cell biologist at UCSD who studies Alzheimer's disease. "The hope is that (stem) cells will let us make that jump now from animals to people, to evaluate disease and then develop therapies."

Patient applications flood worldwide stem cell research center

By Jae-Soon Chang
ASSOCIATED PRESS

November 1, 2005

SEOUL, South Korea - A stem cell research center in Seoul was overloaded Tuesday when it began formally accepting applications from patients seeking to benefit from cloning technology.

The World Stem Cell Hub, led by cloning pioneer Hwang Woo-suk, had announced that it would begin receiving patient registration via the Internet and in person Tuesday morning. Its Web site, inaccessible for hours due to a rush of applications, returned to normal around late morning.

"Our Web site was extremely slow for about three hours from 8 a.m. as there were too many access attempts," said Yang Sung-kee, an official in charge of the Web site management at Seoul National Hospital where the stem cell research center is. "It looked like the server went down, but it didn't."

The official said his team had two network experts on standby in case of attacks on the site from those who oppose cloning technology, but there were no such attempts.

Nearly 2,600 applications were received as of Tuesday morning, said Lim Jong-pil, an official at the research center at Seoul National University Hospital. More applications were still being submitted.

"I'm pinning all hopes on this," said Lee Kil-no, 52, sitting in his wheelchair at the registration center, where dozens of other patients were completing registration forms. Lee said he suffered paralysis from the chest down after falling from a five-story construction site.

"I believe my condition will improve if I get this treatment. I wish I could walk again," he said.

The stem cell bank opened Oct. 19 with the aim of serving as the main center for providing scientists around the world with embryonic stem cells, seen as a potential source of replacement tissue for people with a variety of ailments.

The bank planned to receive applications from patients with Parkinson's disease or damaged spinal cords, who are willing to offer their skin tissue for research purposes. Officials have said it doesn't mean the beginning of clinical tests or treatment, yet applications still surged.

The bank – which will have its first branches in Britain and the United States – is expected to provide other scientists room to get around government restrictions on research into embryonic stem cells.

Many scientists are hoping to accelerate research on embryonic stem cells – master cells that can grow into all the other tissues in the body. However, culling stem cells often involves destroying the days-old embryos harboring them and the Bush administration bans U.S. federal funding for research on all but a handful of older embryonic stem-cell lines.

Hwang has received world recognition for cloning the world's first human embryos and extracting stem cells.

In May, Hwang announced he had created the world's first embryonic stem cells that genetically match injured or sick patients – a major step in the quest to grow patients' own replacement tissue to treat diseases.

Instead of using embryos left over from in-vitro fertilization, the Koreans create them from cloned skin cells. That process is favored by some scientists because cloning can create a perfect tissue match for sick patients. But critics say it condones creating human life for laboratory research.

The World Stem Cell Hub: www.worldstemcellhub.org

South Korean patients flock to worldwide stem cell research center

By Kwang-Tae Kim
ASSOCIATED PRESS

November 1, 2005

SEOUL, South Korea - For the past few decades, Kim Young-ja lived with the thought she would never walk again.

Seeking what she sees as a chance for a cure, the 55-year-old South Korean joined hundreds of patients who applied Tuesday to take part in research with a worldwide stem cell center that hopes to cure hard-to-treat diseases with its trailblazing cloning technology.

"I spent the past 22 years in tears and I had no hope," said Kim, who was paralyzed from the chest down in a 1983 traffic accident with a drunken driver.

She is among thousands of people volunteering skin cells to help launch a global center that will grow embryonic stem cells for research. The World Stem Cell Hub, led by cloning pioneer Hwang Woo-suk, aims to one day help those suffering from ailments such as Parkinson's disease or damaged spinal cords and who are willing to offer skin tissue for research.

But the scientists caution that actual treatment for such ailments is years away. Despite the high hopes of those volunteering for research, scientists don't even know for sure if such future treatments will work.

The Seoul-based research hub opened Oct. 19 with the aim of serving as the main center for providing scientists around the world with embryonic stem cells. They are master cells that can grow into all kinds of tissues in the body and are seen as a potential source of replacement tissue for people with a variety of ailments.

On Tuesday, the first day it accepted applications from patients to participate in research, the center received 3,500 responses from patients via the Internet, telephone and fax or in person, said Lim Jong-pil, an official at the center at Seoul National University Hospital. During the day, the center's Web site was inaccessible for hours due to a rush of applications.

No foreigners applied, although the center is open to them, Lim said.

The center, which will have its first branches in Britain and the United States, is expected to provide other scientists room to get around government restrictions on research into embryonic stem cells.

Hwang has garnered worldwide attention for cloning the world's first human embryos and extracting stem cells from them. In May, he announced he had created the world's first embryonic stem cells that genetically match injured or sick patients – a major step in the quest to grow patients' own replacement tissue to treat diseases.

Instead of using embryos left over from in vitro fertilization, the Koreans create them from cloned skin cells. That process is favored by some scientists because cloning can create a perfect tissue match for patients.

Critics say such research condones creating human life for laboratory use. Removing stem cells often involves destroying days-old embryos, and the Bush administration has banned federal funding for research on all but a handful of old embryonic stem-cell lines.

Officials at the center cautioned that their research is not the start of experimental treatment. Also, not everyone will be accepted; candidates will be screened. And it may take 10 years or more to develop a treatment.

For those suffering from paralysis and left without any other apparent chance for a cure, the wait already has been too long.

Kim, the woman paralyzed by an accident, lamented not being able to care for herself and her two sons. Her husband was also severely injured in the car crash.

"I could not do anything by myself. The feeling of desperation I had was beyond description," she said.

Lee Ae-ja, who registered Tuesday, can walk only a short way with a cane before her pain becomes too intense. The 64-year-old has used a wheelchair since a virus damaged her nervous system more than a decade ago.

"My only wish is to walk with my legs even for some months before I die," she said as her husband filled out an application.

World Stem Cell Hub: www.worldstemcellhub.org

Cytori in stem cell deal with Olympus
Big Japanese firm to put in $30 million

By Penni Crabtree
UNION TRIBUNE

November 5, 2005

Cytori said yesterday it signed a deal with Japan-based Olympus Corp. to jointly develop a device that would allow doctors to treat heart patients with their own healing adult stem cells.

In the nascent field of stem cell therapy, the joint venture is sizable: Olympus will put $30 million into the venture and pay the San Diego adult stem cell company an $11 million upfront fee.

So far, research into embryonic stem cells, which are taken from human embryos, has grabbed more headlines and fueled the $3 billion stem cell research initiative in California. But the quest for therapies from adult stem cells, derived from bone marrow and other sources, is also forging ahead.

A handful of adult stem cell companies are creating potential therapies, including Baltimore's Osiris Therapeutics. Osiris is enrolling patients in a clinical trial to test adult stem cells derived from bone marrow as a way to repair damaged heart tissue.

Cytori, which has headquarters in San Diego but whose shares trade on the Frankfurt Stock Exchange, is working on a similar heart repair treatment that uses adult stem cells extracted from a patient's fat.

Chris Calhoun, Cytori's chief executive, said the deal with Olympus gives the biotech a partner with development and manufacturing expertise to bring a commercial device to market.

The Japanese company, best-known for its line of cameras but also a force in the medical-device business, generated about $8 billion in revenue last year.

"It's an excellent deal for us," said Calhoun, whose company employs 130. "The timing is right, and the partner is right."

Cytori already has developed a prototype device, dubbed the Celution System, for transforming human fat into potential therapies. A small amount of a patient's fat is taken from the thigh or belly and put in the device, which extracts the stem cells and processes and purifies them.

What emerges is a small pellet of concentrated adult stem cells that can be injected into the patient

In rodent studies, fat-derived adult stem cells have been shown to heal damaged heart tissue and bone defects. Last year, in a landmark case, German surgeons used fat-derived adult stem cells to repair severe damage to a child's skull.

Cytori and UCLA scientists have studied heart function in pigs that were injected with fat-derived stem cells. Several months after induced heart attacks, the pigs had significantly better heart function than pigs given a placebo.

Calhoun said the stem cells appear to provide several heart benefits. Not only can they create new heart muscle, but they can induce the formation of new blood vessels and make growth factors that can keep heart cells from dying.

Cytori plans to launch a small clinical trial in Europe next year to test the stem cell treatment in heart patients.

Under terms of the joint venture, Cytori and Olympus will establish a joint venture company called Olympus-Cytori, which will be owned equally by the two companies.

Olympus will license some of its device-related technology and provide $30 million to the venture. Cytori will license its Celution System technology and certain patents.

In addition to the $11 million upfront licensing fee to Cytori, the company will earn an additional $11 million from Olympus if it receives clearance in Europe for the Celution System prototype.

Study: Stem cells help heart after attack

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me@rescam.org

Egg Ethics Spark Stem-Cell Rift

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Missouri priests urge opposition on stem cells

By Alan Scher Zagier
ASSOCIATED PRESS

November 28, 2005

JEFFERSON CITY, Mo. - The battle over embryonic stem cell research moved into the pews yesterday, as Roman Catholic priests across Missouri urged churchgoers to oppose a petition seeking a constitutional amendment that would protect the controversial work.

The petition drive was announced last month by a group of business leaders, patient advocates and researchers as a response to legislative efforts to ban therapeutic cloning, a type of stem cell research.

Missouri's Catholic dioceses oppose it, and urged their priests statewide to begin a campaign yesterday aimed at keeping Catholics from signing the petition.

At St. Peter Catholic Church, across the street from the state Capitol, the Rev. James Smith quoted Nazi propaganda chief Joseph Goebbels and compared the cultivation of human embryos for research to the gruesome experiments performed on concentration camp prisoners during World War II.

"The similarities of the arguments behind the destruction of life by the Nazis and the use of human embryos (for stem cell research) are scary," he told hundreds of worshippers at a morning Mass. "There are real human lives that need our support and protection."

The petition seeks to put a measure on the 2006 ballot to amend the state Constitution to say that stem cell research, therapies and cures allowed under federal law also are permitted in Missouri. The measure would prohibit human cloning, defined as the effort to create a baby by implanting an embryo not fertilized by sperm.

Supporters argue that stem cells may have the potential to cure spinal cord injuries, Parkinson's, Alzheimer's and other life-threatening diseases.

Opponents contend that the use of embryonic stem cells involves creating human life to destroy it. "Human embryos are not potential human beings. Human embryos are human beings with potential," John Weaver, deacon of Sacred Heart Catholic Church in Columbia, told worshippers.

Donn Rubin, chairman of the petition coalition, Missouri Coalition for Lifesaving Cures, said surveys show that most Missouri Catholics support stem cell research. Republican Gov. Matt Blunt and former U.S. Sen. John Danforth, an ordained Episcopal priest and former U.N. ambassador, are among the measure's supporters. The petition drive must have about 145,000 valid signatures by May 9 to qualify for the November 2006 ballot.

A constitutional amendment would require a simple majority of voters to be enacted and would supersede any state laws.

Stem cells survive challenge - But judge will let foes of initiative try again

By Terri Somers
Union-Tribune

November 30, 2005

California's stem cell initiative survived another legal challenge yesterday when an Alameda County judge declined to rule it unconstitutional based on papers already filed with her court.

In a preliminary ruling, Superior Court Judge Bonnie Sabraw left the door open for challengers to make one final argument, but she set a high bar that they would have to meet to persuade her that the initiative is unconstitutional.

"The Supreme Court has stated that it is the court's solemn duty to uphold an initiative, resolving all doubts in its favor, unless its unconstitutionality clearly, positively and unmistakably appears," the judge wrote in a 22-page ruling issued late yesterday.

"This is a substantial test, and one which (one of the plaintiffs) has not satisfied here," the judge wrote.

Robert Klein, an author of the initiative, saw the ruling as "a triple, although not the home run we had hoped for."

"I'd like to proceed in any and every trial in this position," said Klein, who is chairman of the committee set up to oversee the initiative's implementation.

Lawyers representing the California Institute for Regenerative Medicine, which was created by the initiative, had argued that the judge should throw out the legal challenges based solely on legal papers filed with the court and arguments made in a two-hour hearing earlier this month.

Three groups claiming to be consumer advocacy organizations have challenged the initiative on several legal grounds. The groups have ties to anti-abortion groups that object to embryonic stem cell research because it requires the destruction of a human embryo. But the lawyers and the groups they represented have repeatedly said this case is not about moral objections.

Lawyers challenging the initiative could not be reached for comment last night.

The legal wranglings have prevented the state from selling $3 billion in bonds to fund the initiative that was approved by 59 percent of the voters a year ago and allocates $300 million annually to controversial stem cell research.

Sabraw's ruling does not eliminate the legal hurdles and allow the state to begin selling those bonds. But Klein said it sends a positive message to philanthropic groups that might lend the initiative money to fund its operations until the case is settled.

Currently, the California Institute for Regenerative Medicine is operating on a $5 million donation from Ray and Dagmar Dolby, who have made a fortune from sound systems. That money is expected to run out around May, Klein has said.

Sabraw noted that some of the legal challenges are similar to those made against Proposition 10, the 1998 measure that levied a 50-cent-a-pack tax on cigarettes to finance children's health and education programs.

In that case, she said, the judge first considered written arguments and the text of the ballot initiative and the explanatory pamphlet sent to voters. But then that judge also agreed to review more evidence.

Sabraw believes the Proposition 10 case set legal precedent, and now she will consider additional evidence from both sides in this case.

Scientists can keep ownership of stem cell work
State institute amends policy

By Terri Somers
UNION-TRIBUNE

December 7, 2005

DUARTE – Scientists who make a patentable discovery with grant money from California's fledgling stem cell institute will be able to retain ownership of that discovery under an interim policy approved yesterday by the committee overseeing the institute.

The institute's policy governing the discoveries it funds, which are referred to as intellectual property, is similar to the federal policy that dictates how scientists and research institutes are to handle discoveries they make with funds from the National Institutes of Health.

But California's policy departs from federal law by stressing that the results of all research conducted with stem cell institute funds should be shared as broadly as possible. It would allow scientists at nonprofit institutes around the world to try to build upon those discoveries without having to pay for them.

And, unlike the federal policy, it says the state should receive a portion of any money that a company pays a researcher or his organization to license a patent that results from California taxpayer-funded research.

Exactly where that money will be put – perhaps in a nonprofit foundation that would make stem cell therapies available to people who can't afford them – is among the issues that will be worked out in coming months before a final policy is adopted.

It is an intricacy that taxpayer advocates will be watching closely.

"Taxpayers did not mean to write you a blank check," John Simpson of the Foundation for Taxpayer and Consumer Rights told the oversight committee yesterday at its monthly meeting.

Simpson's organization, other consumer advocates and elected state officials have been lobbying for the oversight committee to adopt a policy that would return at least a portion of the profits from any new therapies to the taxpayers. Some have argued for a program to make new therapies available to Californians who cannot afford them.

Many taxpayer advocates don't like the federal research funding policy because it does not require that any of the money made from government-funded research to be returned to the government agency that issued the grant.

"California is setting a new model. So why is it looking to a flawed national model?" Simpson asked. "We can set a new standard for everyone else."

The committee overseeing the stem cell institute, known as the California Institute for Regenerative Medicine, has been working for months on developing an intellectual property policy. It has held numerous public hearings on the subject.

And the California Council on Science and Technology, an ad-hoc group of academics and professionals, researched the matter and said the institute should closely follow the federal intellectual property policy known as the Bayh-Dole Act of 1980.

Bayh-Dole was designed to encourage drug companies and venture capitalists to invest the millions of dollars needed to turn discoveries made at universities and research institutes into new drugs and therapies.

Although litigation has stopped the stem cell institute from actually distributing any money, institute President Zach Hall said the institute must have in place policies governing how the money is to be used.

Stem cell research funding is wrapped up in legal bills

Terri Somers
Union-Tribune

December 8, 2005

A year and a month after California voters resoundingly approved a plan to spend $300 million annually on stem cell research, not one dime has been given to scientists.

But the legal bills are mounting.

Of the $772,000 the state's fledgling stem cell institute has earmarked for paying its law firm through June 2006, about one-fourth of the money has been spent on lawyers defending the initiative against constitutional challenges, said Zach Hall, the institute's president.

The institute also has a $240,000 legal bill from the state attorney general's office for legal services, which include defending it in the court challenges. "I don't think the voters who so clearly supported this initiative realize that not a dime has been spent on the science and trying to get new cures to people who need them," one of the stem cell proposition's authors, Robert Klein, said Tuesday.

The California Institute for Regenerative Medicine, which was created by Proposition 71 to manage the research grant money, cannot obtain the bond money to fund the research while the legality of its existence is being challenged.

The legal challenges aren't expected to end anytime soon.

"We'll take this all the way up the chain if we have to," said Dana Cody, one of the lawyers arguing against the stem cell initiative.

A Superior Court Judge in Alameda County on Tuesday set Feb. 27 as the date of the trial during which California's stem cell organization must fight for its life.

Cody has argued on behalf of her client, The People's Advocate, that the stem cell initiative is unconstitutional because no elected officials have direct control over the $3 billion in taxpayer dollars that it calls for spending over the next decade.

"This is a taxpayer issue and Bob Klein managing to have access to taxpayer money that he isn't entitled to, no matter how Bob Klein spins it," Cody said.

Lawyers representing the stem cell initiative have argued that Proposition 71, a constitutional amendment, is the will of the people. It passed with 59 percent of the votes in November 2004.

Cody's employer, the Life Legal Defense Fund, is against abortion and represented the parents of comatose Florida woman Terry Schiavo in a failed attempt to keep her on life support.

Cody and the other lawyers and their clients challenging the stem cell initiative have said their problem with Proposition 71 has to do with oversight of taxpayer dollars and accountability, not their anti-abortion views.

A first at Salk: human stem cells in brains of mice

Mice grow human brain cells after stem cell injections

I think it is sad that there are so many people trying to stop this research.
My grandad had Alzheimer's and it was terrible the way he just disappeared inside himself.
He was lost to us a long time before he actually died.

Surely the lives of people who we love and value are worth more than the rights of a bundle
of cells that aren't even human, that can't feel, think or love.

The critics of this science are people who don't really understand it.

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Reality Internet Personality

Ex-collaborator challenges work by stem cell scientist

ASSOCIATED PRESS

December 14, 2005

SAN FRANCISCO – Some of stem cell researcher Hwang Woo-suk's high-profile human cloning work announced earlier this year may have been "fabricated," a former top collaborator charged as he attempted to distance himself from the groundbreaking research.

University of Pittsburgh researcher Gerald Schatten has demanded that the journal Science remove him as the senior author of a report it published in June to international acclaim. The report detailed how individual stem cell colonies were created for 11 patients through cloning.

"My careful re-evaluations of published figures and tables, along with new problematic information, now casts substantial doubts about the paper's accuracy," Schatten wrote in a letter to Science released late yesterday by Pitt. "Over the weekend, I received allegations from someone involved with the experiments that certain elements of the report may be fabricated."

Pitt spokeswoman Jane Duffield said Schatten wouldn't make any further comment while the university investigated the matter.

Schatten's highly unusual demand, in a letter that Science confirmed receiving yesterday, adds to growing skepticism over Hwang's findings and places the entire cloning and stem cell field under a cloud.

Many stem cell scientists had stood by Hwang's work even as he admitted to ethical lapses and minor data reporting errors.

Now, a significant number are calling on Hwang to submit his cloning research to independent analysts to bolster public confidence, which they perceive as eroding because of the continued controversy over Hwang's work.

Schatten set off the ethics furor last month when he publicly accused Hwang of collecting eggs from subordinate scientists, a practice many consider unethical, and lying about it to him.

But until now, even Schatten has maintained that the main findings of the paper – that tailor-made stem cells were extracted from embryos cloned from the DNA of sick volunteers – were valid.

Science has said he has no reason to believe Hwang's primary finding "is any way fraudulent or questionable."

Stem cell scientists hope to clone embryos to extract stem cells in order to better learn how diseases develop and even perhaps rejuvenate failing organs. The basic idea of cloning is to take a patient's genetic material and inject it into an unfertilized human egg. The implanted DNA then drives the egg to develop into an embryo.

Hwang is considered a national hero in South Korea for his cloning prowess. He has publicly apologized for the ethical lapses and quit as head of the World Stem Cell Hub, an international project he had launched in October that envisioned California and British labs in addition to a facility in South Korea.

At the time, Hwang defended his work as scientifically sound.

Human stem cell culture research by S. Korean scientists called fake

By David Brown
THE WASHINGTON POST

December 16, 2005

WASHINGTON – Most and possibly all of the human embryonic stem cell cultures reportedly made by a South Korean research team this year were fake, a member of the team told Korean news outlets yesterday.

Roh Sung-il, an executive at MizMedi Hospital in Seoul, said stem cell pioneer Hwang Woo-suk told him nine of 11 reported cell lines were faked. Roh reportedly said he had doubts about the remaining two lines.

Hwang apologized today for the controversy but stood by his work, saying it would be authenticated after tests performed within days.

Roh also said Hwang told him that his stem cells had died and that he had presented ones from Roh's laboratory as his own in their research paper in the journal Science.

Hwang acknowledged at a news conference today that the cells created for the Science article had all died after being contaminated.

According to the Korean news reports, the two agreed they would ask the journal to retract the paper, which was published May 19.

That paper and another landmark report by Hwang's group, published last year, had documented the first successful creation of embryonic stem cells from cloned human embryos – a big step toward the ability to grow customized tissues for transplantation into people with failing organs.

If the work does prove to be largely fraudulent, it will be a major scientific setback for one of the most talked-about new avenues of biomedical research. It could also be a major political setback for the field, which has long been mired in controversy because it depends on the creation and destruction of human embryos.

Most such research is being done outside the United States because federal law prohibits the public funding of it here, but Congress is poised to consider loosening restrictions.

Roh's statements were reported by three TV networks and in the Korea Times. Neither he nor Hwang nor their sole U.S. collaborator, Gerald Schatten of the University of Pittsburgh, could be contacted directly.

The four top editors of Science sent e-mails yesterday to all of the paper's authors seeking clarification.

Suspicions about the accuracy of some details in the May paper arose before yesterday.

On Nov. 12, Schatten, who holds faculty appointments in reproductive sciences and cell biology at Pittsburgh, announced he was severing his 20-month collaboration with the Korean scientist. On Monday, Schatten asked Science to remove his name as an author on the May article. The journal refused.

On Dec. 4, Hwang told Science's editors that four pictures of stem-cell-derived tissue published online with the May paper were duplicates. That happened unintentionally, he said.

On Dec. 1, the chairman of the institutional review board that reviewed Hwang's research proposals for ethical and scientific integrity told the editor of Science that two junior scientists in Hwang's laboratory had provided the eggs and had been paid $1,145 for expenses, although earlier papers said donors had not been paid.