Stem cell industry Q&A
How many clinics are there?
No one really knows for sure. Two scientists who have been observing the for-profit industry for years estimate there were 715 clinics operating as of 2017, and they believe there are more now. California has more clinics than any other state.
What treatments do the clinics offer?
None of the treatments are FDA approved. The therapies generally can be divided into three categories: stem cells drawn from a patient’s own fat; stem cells drawn from a patient’s bone marrow; and so-called amniotic stem cells, which come from donated amniotic fluid and tissue. There is some debate over whether the amniotic cells are stem cells at all.
In most cases, the stem cells are condensed and given to patients by injection.
What illnesses do the clinics claim to treat?
Bone marrow stem cells generally are given to people with joint or back pain. Clinics that sell fat and amniotic stem cell products market them for a wide variety of illnesses, including multiple sclerosis, Parkinson’s disease, lung diseases and autism. There is no evidence that the products are effective at treating those maladies.
How much do the therapies cost?
Insurance almost never covers the cost of stem cell therapies provided by for-profit clinics. The outof-pocket cost for patients can range from a few thousand dollars to more than $50,000 per treatment.
How are the clinics regulated?
The FDA issued guidelines in 2017 to clarify what types of stem cell products could be sold directly to consumers. Fat stem cell products were generally not allowed without specific FDA permission. Last year, the FDA requested injunctions to stop two major stem cell providers from selling fat-based products. One of those injunctions, against a clinic based in Florida, was approved earlier this year. The second injunction, against a network based in Southern California, awaits a court ruling.