At the top of the list of predatory business schemes, direct-to-consumer clinics selling unproven stem cell therapies may well top the list with payday loans and Shkreli-like drug prices. Such clinics can promote dangerous, often exorbitantly priced ‘treatments’. They often target vulnerable and desperate people, including terminal cancer patients, parents of autistic children, and adult children of parents with Alzheimer’s or Parkinson’s disease. And the results can range from placebos to bones in eyelids and scary growths on spinal cord.
We tend to think that this kind of quackery only thrives in countries with lax regulations like China, India or Mexico. The phrase “stem cell tourism” usually conjures up air travel. But stem cell therapies are unexpectedly thriving in the US and may only require a short car ride.
This is according to an analysis published this week in Cell Stem cell, researchers identified as many as 351 companies across 570 US clinics offering stem cell therapies that are largely unproven and unapproved by the Food and Drug Administration. With no peer-reviewed evidence, these companies and clinics claim their therapies can treat dozens of diseases, injuries, and cosmetic indications, including joint pain, autism, spinal cord injury, muscular dystrophy, and breast enlargement. Costs can run into tens, if not hundreds of thousands of dollars for treatments.
“Our analysis should be a valuable resource for the contemporary debate about whether the US marketplace for stem cell interventions is adequately monitored and regulated by the FDA, Federal Trade Commission, state medical boards and other agencies charged with promoting patient safety and accurate advertising. ”, the authors conclude.
Stem cells, some of which can differentiate into almost any type of cell in the body, hold tremendous promise for many types of treatments. But so far, the only type of stem cell treatment that has been scientifically verified and approved by the FDA is bone marrow or blood stem cells used in transplants to treat cancer or other conditions that affect the immune system and blood. Clinics using these approved treatments can be safe and compliant with FDA rules.
However, many clinics probably don’t fall into that category. Seizing on the scientific excitement, these clinics have made exaggerated or false claims that stem cells can treat or cure a wide variety of other conditions. And they’ve drifted to use different cell types. In their analysis, Leigh Turner, a bioethicist at the University of Minnesota, and Paul Knoepfler, a stem cell researcher at the University of California, Davis, found clinics promoting stem cells made from patients’ fat called “placental” stem cells (originally unknown), and cells that are probably not stem cells of any kind, as well as ‘bovine amniotic fluid cells’.
So far, many of these clinics have largely escaped the wrath of regulatory authorities, perhaps because in the past they’ve typically extracted cells from patients, performed minor manipulations on them, and then returned them to the same patient. Procedures such as these can involve relatively few risks. However, with the apparent boom of the stem cell industry, the FDA is now moving forward with a draft guideline that would classify most stem cells used in clinics as drugs, requiring a difficult approval process.
By highlighting the breadth of the stem cell industry currently in the US, Turner and Knoepfler hope to help the FDA and other regulatory agencies curb the dangerous effects of unproven treatments. Last week for example The New York Times wrote about the case of Jim Gass, who spent hundreds of thousands of dollars to get stem cell treatments from Mexico, China and Argentina that would help him recover from a stroke. When he returned to the US, surgeons found a large bloody mass of primitive cells aggressively taking over his lower spine. The cells didn’t belong to Gass. And in another case several years ago, a woman who received a stem cell-based facelift treatment from a California clinic had to have bone fragments surgically removed from her eyelid months later.
Editor’s Note: This story has been updated to clarify that not all stem cells can differentiate into nearly every type of cell in the body.
Cell Stem cell2016. DOI: 10.1016/j.stem.2016.06.007