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‘Ethical’ stem-cell work advances

- The Washington Times - Sunday, December 6, 2009

BOSTON | Several Massachusetts firms are forging ahead with ambitious stem-cell research plans, circumventing the heated debate over embryonic research by using other, less-controversial methods.

Biocell Center, a European technology firm, has opened the first amniotic-fluid stem-cell bank in the United States in Medford, Mass., near Boston. Another Boston-area biotech firm, Advanced Cell Technology in Worcester, Mass., uses a nondestructive technique that involves working with a single cell from an embryo in a project aimed at preventing blindness.

Massachusetts, which has one of the nation's best-educated work forces, has been at the center of stem-cell research since Gov. Deval Patrick's recent $1 billion, 10-year Life Sciences Initiative, which was intended to make the state a world leader in the field. One of its first successes was the Biocell Center project, which plans to provide cryogenic storage of stem cells for families, medical centers and scientists.

"This builds on our strength - a concentration of brainpower, research, hospitals and other institutions, venture capital and imagination," Mr. Patrick said. "The [biotechnology] cluster is helping to lead Massachusetts out of this recession and give hope to people who are suffering."

Perhaps more significant, the Biocell Center avoids the moral controversy triggered by embryonic stem-cell research. The company harvests and stores stem cells from the amniotic fluid surrounding an unborn child in the uterus, a process that does not interfere with the fetus itself.

"The [stem-cell] controversy involves embryonic stem cells, and we are working with non-embryonic, so we are out of that debate," said Kate Torchilin, Biocell's chief executive officer.

The company, which has built a large stem-cell bank in Europe, collects samples only from women who undergo amniocentesis, a prenatal procedure that requires the removal of a small amount of amniotic fluid to test for specific birth defects. A sample from the extracted fluid, which is normally discarded, goes to Biocell for isolation and storage if the mother requests it.

The preserved cells can potentially be used in the future to repair tissue or treat diseases. Because they are from the individual's own amniotic fluid, the risk of rejection by the body is minimized.

"Stem cells are present and powerful in the second trimester of pregnancy, and we have a chance to collect a sample without interfering with the normal course of clinical care," Ms. Torchilin said.

Amniotic-fluid stem cells underscore the advances in so-called "ethical" stem cells, which hold the potential to revolutionize medical treatment without being contentious. Yet reports of progress in this area tend to stay out of the spotlight.

Massachusetts already has several storage facilities for stem cells derived from umbilical-cord blood, which offer a natural, controversy-free method of acquiring stem cells, said Lucy Bayer-Zwirello, chief of maternal-fetal medicine at St. Elizabeth's Medical Center in Boston.

Advanced Cell Technology is currently applying to the Food and Drug Administration to start human trials to prevent blindness with a single stem cell taken from an embryo without harming it. The company is targeting macular degeneration and has had complete success in animal trials, said Robert Lanza, ACT's chief scientific officer.

"We took one cell and let the remaining embryo develop with no harm," Mr. Lanza said. "We know how to routinely generate stem-cell lines without harming or destroying the embryos.

"This may be the first human embryonic stem-cell therapy in patients, ever," Mr. Lanza said. "We desperately need big clinical success."

Stem cells hold the potential to become a repair kit for the human body, as well as a way to treat a long list of debilitating diseases, including Alzheimer's, diabetes and heart disease.

Various types of stem-cell research exist. Embryonic, fetal, induced pluripotent (adult stem cells regressed to an embryonic state) and adult are the main types, each with its own limitations.

"This is not a one-size-fits-all," Mr. Lanza said. "There will be a combination of approaches depending on the disease."

Public debate specifically targets embryonic stem-cell research. These stem cells are primitive and potent, thus offering the greatest promise because they are able to become virtually any cell in the human body.

But the usual process of harvesting the stem cells destroys the human embryo (or human clones), a practice condemned as immoral by many religious and conservative groups. In 2001, President Bush prohibited federal funding for research into new embryonic stem-cell lines, though he did not ban funding for the existing 21 lines.

The funding ban was seen as a profound setback in U.S. stem-cell research by many scientists. Several states, including Massachusetts, responded by passing laws to permit human embryonic stem-cell research using state funds.

In March, President Obama lifted restrictions on federal funding for research on new stem-cell lines.

The National Institutes of Health has issued guidelines that allow federally funded research on stem cells derived from embryos specifically donated for that purpose by fertility clinic patients. The NIH received $10.4 billion in stimulus funds and intends to fund additional embryonic research under its new guidelines.

Opposition to embryonic stem-cell work remains, but most groups distinguish it from other stem-cell work.

"We enthusiastically support all avenues of stem-cell research that do not require the destruction of human life and that do not require the creation of new human life by cloning to produce embryos to be destroyed in research," said Gene Tarne, spokesman for Do No Harm, the Coalition of Americans for Research Ethics, based in Washington.

Embryonic stem cells have specific-use drawbacks as well. They have not yet yielded treatments approved for the market, and they can also produce genetic abnormality.

"Embryonic stem cells occasionally form tumors when they grow," said Ms. Torchilin, from Biocell Center. "Data from our company shows that amniotic-fluid stem cells remain healthy."

Research on non-controversial stem cells is producing dramatic results that are virtually unknown to the public, said Jean Peduzzi-Nelson, associate professor at Michigan's Wayne State University, who is involved with stem cell work on spinal-cord injury.

She described a recent European trial of adult stem-cell therapy combined with intense rehabilitation that allowed a quadriplegic patient to walk using a walker.

"These are fantastic results that most people don't know about," Ms. Peduzzi-Nelson said. "It's a silent explosion in the medical field."

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