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Dozens of Research Trials Explore Use of Stem Cells Against Diseases

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Tuesday, September 2, 2008

As academic researchers fret about overseas stem cell providers, some 50 human trials of various types of stem cells are underway in the United States. Most involve so-called adult stem cells plucked from the blood or bone marrow. The studies, approved by the Food and Drug Administration, are testing the cells' utility in the battle against heart disease, the digestive disorder Crohn's disease and other conditions.

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One small study, launched last year, implants fetal brain stem cells in children with a rare metabolic disorder, Batten disease.

As for embryonic stem cells, those grown from embryos just a few days old, human testing has not yet been approved in the United States. A California company, Geron, hoped to begin implanting nerves grown from embryonic cells into people with spinal cord injuries this summer. But in May the FDA put a hold on the study.

Several studies of blood and bone marrow stem cells taken from a patient, grown in a lab and then injected back into the patient's heart show a "modest benefit" for some patients, concluded an article in the Feb. 27 Journal of the American Medical Association. The article recommended further testing.

Developing stem cells into viable treatments is a long, expensive process, said Randal Mills, chief executive of Osiris Therapeutics Inc. The Columbia-based company began human testing of its adult stem cell product, Prochymal, in 1998. After a decade and "several hundred million dollars," Prochymal is still being tested. Each vial of cells undergoes "at least 100" safety and purity checks, Mills said. Osiris hopes to win full FDA approval next year for Prochymal to treat graft-vs.-host disease, an often-fatal consequence of organ and bone marrow transplants.

Stem cell researchers expect a proliferation of FDA-approved stem cell trials in the coming years, and they caution that patients who travel and pay for stem cells won't qualify. Jeannine Richardson learned this firsthand when she tried to join a trial of Prochymal for chronic obstructive pulmonary disease. Osiris turned her down because she had gotten a stem cell injection in Mexico.

Fia Richmond, whose developmentally disabled son did not improve after offshore stem cell injections, encourages patients to donate to research instead of paying for offshore stem-cell treatments. After her disappointing experience, Richmond founded the Children's Neurobiological Solutions Foundation, which funds stem cell research in the United States.

Although experts say stem cell research is speeding ahead, the pace seems devastatingly slow for patients. "I couldn't wait 10 years while they fiddled around," said Barbara Hanson, who has chronic obstructive pulmonary disease and traveled to Mexico for stem cells. "I don't have the time."

Searchable listings of FDA-approved clinical trials are available at www.clinical trials.gov.

-- Brian Vastag


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