FDA has no authority over procedures using adipose-derived stem cells
THURSDAY, Sept. 10, 2015 (HealthDay News) — Hundreds of clinics across the United States are offering unapproved stem cell treatments for conditions from hair loss to heart failure and Alzheimer’s disease, researchers report in the Sept. 10 issue of the New England Journal of Medicine.
“These for-profit stem cell clinics operate outside mainstream regulatory frameworks normally in place to protect patients,” lead author Hermes Taylor-Weiner, Ph.D., of the University of California, San Diego, bioengineering department, told HealthDay. “These clinics are selling stem cell treatments that have not been shown to be safe or effective, so they are unproven,” he said.
Conservatively, Taylor-Weiner estimates hundreds of clinics perform unapproved stem cell treatments in the United States. In reality, he said, thousands may operate throughout the country. The U.S. Food and Drug Administration has only approved a few stem cell treatments. The approved procedures utilize cells from bone marrow to treat diseases of the blood or immune system, the report explained. On the other hand, most of the clinics referred to in the new report use fat cells taken from patients during liposuction, Taylor-Weiner said. The cells are processed, and the stem cells isolated and injected back into the patient. The procedure is packaged as a product called stromal vascular fraction (SVF).
The report calls for tighter federal regulations. However, because these clinics use a patient’s own cells, the treatments are considered the practice of medicine and, as such, beyond the FDA’s authority, said Sarah Peddicord, an agency spokeswoman. “We can only follow the laws that have been created,” she said. “Our oversight of stem cells is to ensure that communicable diseases aren’t transmitted.” Without FDA approval, the SVF treatments aren’t covered by insurance, so a patient’s costs can run from $5,000 to $50,000, according to the report.
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