June 1, 2011
Critics say the stem-cell infusion can be expensive, costing $10,000 or more, and is not covered by insurance. The treatments have never been through clinical trials mandated by the Food and Drug Administration to test their safety and effectiveness, and as a result are not FDA approved.
“We don’t have any approved stem-cell therapy for heart patients in the U.S. or anywhere in the world,” says Wael Jaber, a Cleveland Clinic heart specialist. Jaber says he learned of the stem-cell clinics from a patient who told his doctors he paid thousands for stem infusions for coronary artery disease.
Stem cells hold promise because they are the precursors of other cells in the body and offer hope for regenerative medicine. The only currently approved use for stem cell therapy are bone marrow transplants, used for 40 years to treat patients with leukemia and sickle-cell anemia. Virtually every other stem-cell therapy is highly experimental, doctors say.
No one knows exactly how many doctors in the U.S. and abroad provide patients with untested stem-cell therapies. But the phenomenon has provoked concern among such groups as the International Society for Stem Cell Research and the non-profit ALS Therapy Development Institute.
“It’s a concern of the entire research and medical community,” says Steven Perrin, chief science officer for the ALS group. “They’re being hyped around the world.”
The International Cell Medicine Society, a professional group for doctors who provide stem-cell therapies to patients, claims more than 1,000 members. And an online patients’ discussion forum called Stem Cell Pioneers has 1,200 members who say they have had stem-cell therapy or are seeking it.
U.S. doctors who use the purported stem cells for treatment contend they’re not subject to FDA regulation because they simply collect patients’ stem cells from blood, bone marrow and fatty tissues and reinfuse them without altering them much. FDA regulations allow doctors to infuse patients with their own cells, so long as the cells are only “minimally manipulated” and not significantly altered.
“Unfortunately, there are many loopholes in FDA regulations,” says George Daley, director of stem-cell transplantation research at Children’s Hospital in Boston. The FDA declined to comment for this story because the agency is mired in litigation over its power to regulate stem-cell clinics.
FDA’s adversary in that litigation is Colorado orthopedist Christopher Centeno, who treats joint ailments with stem cells. Centeno argues that FDA regulations give doctors latitude to develop new procedures for treating patients. As soon as this fall, he says, a federal judge will decide.
Daley says he sympathizes with the desperation expressed by critically ill patients —and with their doctors’ eagerness to try new things. Still, he says, it pays to be cautious.
“Lots of patients have been harmed,” Daley says, “by otherwise well-intentioned but misinformed practitioners.”