Where are regulators as hundreds offer so-called ‘stem cell’ care?

stemcellBeneficial therapies can topple over to medical nightmares in a blink, especially when regulators seem to have looked askance or even shut their eyes and slumbered. The Food and Drug Administration may need to look into what  is going on with the burgeoning business of so-called stem cell treatments.

Two academics took to the Internet and found “at least 351 businesses in 570 locations …marketing stem cell therapies that have not been fully vetted by medical researchers or blessed by the U.S. Food and Drug Administration,” they reported in the peer reviewed, academic journal Cell Stem Cell.

To be sure, they did not visit the facilities in person, and they use care not to describe any of them as violating state or federal laws or regulations. They used rigorous, robust online means, though, to look at the operations’ Internet pitches, which, as The Los Angeles Times notes:

If the clinics are to be believed, there’s no medical problem that stem cells can’t fix. More than any other type of condition, the websites claimed to treat orthopedic and sports medicine problems, such as wear and tear on muscles and joints. Pain was another common indication for stem cell treatments. Some clinics said they [could] enhance cosmetic procedures such as breast augmentation and … improve sexual function. The cells were also touted for … heart disease, immune system disorders, spinal cord injuries, lung disease and neurological conditions such as Parkinson’s disease, amyotrophic lateral sclerosis (aka Lou Gehrig’s disease) and Alzheimer’s.…Of particular concern … were clinics that targeted parents of children with autism, cerebral palsy and muscular dystrophy.

The researchers conservatively offer that many of these advertised treatments “do not fit FDA criteria,” and many may not be “compliant with federal regulations.” Many of the websites are explicit that their treatments are not FDA approved, while others denied the agency’s OK was needed.

The FDA last fall issued draft guidance for the industry and its staff, and is seeking comment on proposals to regulate stem cell therapy.

So-called stem cell clinics, meantime, seem to cluster in cities like Los Angeles, Beverly Hills, New York, Phoenix, and Scottsdale, and in states like California, Texas, Arizona, Florida, and New York.

Operators, online, varied in their assertions as to where they obtain what they call stem cells, with many claiming they could draw them from patients themselves and some saying they were from amniotic fluid, placental tissue, umbilical cords, “embryonic,” and even bovine in derivation.

If that’s insufficient yuck factor to make prospective, gullible patients run for the door before subjecting themselves to questionable care, the New York Times recently reported on a one-time corporate lawyer, who, after suffering stroke-induced paralysis, used his financial means to try “stem cell tourism.”

He read about his condition, scoured the Internet, and ended up on a global odyssey, traveling to Mexico, China, and Argentina in hopes that tissue injections, purportedly of stem cells, some supposedly from Russia, would ease his partial paralysis and limb atrophy. The travel and treatments cost him almost $300,000, and, he says he briefly improved. Then he sharply worsened.

He fell more, and felt great pain in his lower back. On a visit to Thailand, doctors tried to tap his spinal fluid for diagnosis; they drew none. The lawyer flew to Boston, where he spent much of his life and had family to try to help.

He underwent a back scan, and what surgeons saw prompted them to operate quickly. In doing so, they made a ghastly finding: Growing all around his spine was a mass of bloody tissue–abnormal, primitive, aggressively expanding cells. They were not his. They were somebody else’s, propagated in him during his many “stem cell” treatments.

Doctors were uncertain how to treat the mass, which has paralyzed the patient from the neck down now, and finally decided on radiation. That worked. But he says recent tests show it is growing anew.

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