In April 2019, the Federal Trade Commission returned almost $515,000 to consumers who bought deceptively marketed “amniotic stem cell therapy” between 2014 and 2017. That came after the agency found that osteopath Dr. Bryn Jarald Henderson and the companies he owns and operates, Regenerative Medical Group and Telehealth Medical Group, deceptively advertised that their amniotic stem cell therapy could treat serious diseases, including Parkinson’s disease, autism, macular degeneration, cerebral palsy, multiple sclerosis and heart disease.

A drop in the bucket

Across the country and around the world, the proliferation of unproven cellular therapies is a $2 billion business, according to a recent paper in Cytotherapy, co-authored by an impressive international team of stem cell experts who were at a symposium for the International Society for Cellular Therapies in 2018. Another study, in the journal Perspectives in Biology and Medicine, looked at the marketing claims of 716 stem cell clinics in the U.S. and found that “what at first glance might appear to be credible and compliant clinical research often is highly problematic.”

According to the International Society for Stem Cell Research, to date the only scientifically verified (and reliable) use of “stem cell treatments are blood stem cells to treat diseases of the blood, such as leukemia, and for tissue grafts to treat diseases or injury to the bone, skin and surface of the eye. Important clinical trials involving stem cells are underway for many other conditions, and researchers continue to explore new avenues using stem cells in medicine.”

How did we get here?

According to Pro Publica, around 15 years ago the Food and Drug Administration decided that human tissue (including stem cells) — if it was “minimally manipulated” and used in the same way it originally functioned in the body — didn’t need FDA approval as a drug. However, if the cells were modified in a lab or given a new purpose, such as using cells from the placenta to ease arthritic joints, they would be considered a drug and would have to undergo FDA review. The catch: Manufacturers got to decide if their products were drugs or not. Saying “not” saved them millions of dollars, and went largely unchallenged by the FDA.

Finally, in 2017 guidelines were established that may tighten up the oversight on tissue such as amniotic stem cells, but they don’t go into effect (if they do) until 2020.

The risks

Stem cell treatments are enormously expensive, and out-of-pocket costs can hit tens of thousands of dollars with little benefit. They flop in part because all stem cells are not created equal and are not equally effective in stimulating creation of new tissue. Shady clinics offer everything from autologous fat stem cells from your thigh to ones obtained from amniotic fluid and the placenta. Says Jeanne Loring, the director of the Center for Regenerative Medicine at the Scripps Research Institute and chief scientific officer at Aspen Neuroscience: “If a stem cell from one organ is put into another, like a placenta or umbilical cord cell into a knee, it will die. It can’t become something else.” Only cells from embryos or ones that are manipulated in the lab before injection can become any kind of cell and at least in theory be used to repair any tissue or organ.

But the damage to your pocketbook is the least of it. Last December, the Centers for Disease Control and Prevention reported that 12 people contracted bacterial infections from contaminated stem cell treatments using umbilical cord blood. That’s just one example of the hazards, which include death.

If you’re interested in stem cell therapy, your smart move is to look for a university or reputable medical center clinical trial to join — but only after talking to your doctors about your particular health issue and the risks involved. The ISSCR stresses that not all clinical trials are equal, and offers step-by-step guidance to joining one on stem cells. Go to www.closerlookatstemcells.org and search for “clinical trials.”

The You Docs’ column runs in Wednesday’s Extra.

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