Feb 2016

FDA to crack down on clinics peddling unproven stem cell treatments

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Federal regulators in the United States are about to crack down on hundreds of clinics peddling pricey stem cell therapies to treat a laundry list of diseases and conditions without scientific evidence to back them up.

According to a report by STAT, an online health and medicine news service, some 200 stem cell clinics have cropped up in recent years, selling injections, facelifts, and treatments that have not undergone clinical trials.

Many of the clinics use a procedure called stromal vascular fraction (SVF) in which cells are extracted from a patient by liposuction, run through a centrifuge to collect the adipose (fat) stem cells and returned to the patient intravenously or injected at the site of the condition. Clinics promote the SVF procedure to treat a variety of conditions such as arthritis, Parkinson’s disease, pulmonary fibrosis, chronic obstructive pulmonary disease, multiple sclerosis, cerebral palsy, and amyotrophic lateral sclerosis. Treatments can cost anywhere from $5,000 to $25,000.

The American Food and Drug Administration (FDA) recently issued draft guidelines on the use of human cells, tissues, or cellular or tissue-based products and will hold a public hearing on April 13 at Silver Spring, Maryland to help finalize its stand on such treatments.

As STAT reported,  the FDA already sent a warning letter  to a network of stem cell clinics in California, New York, and Florida advising the owner that he needed FDA approval to sell and use stem cells, which the agency classified as biological drugs.

FDA approval requires evidence that stem cell treatments are safe and effective, which, as the article points out, “takes drug companies many years of clinical trials to obtain, at a cost of millions of dollars.”

Canadian bioethicist Dr. Leigh Turner of the University of Minnesota has long criticized the FDA for failing to crack down on the clinics as the mushroomed across the U.S. “If it’s not safe and it’s not going to help patients,” Dr. Turner told STAT. “It’s just predatory behavior.”

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