Unproven Promotion and Performance of Stem Cell Treatments

In October 2015 the FDA issued the following fraud warning on stem cell therapies:

FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications.

The appropriate, clinically proven and beneficial use of stem cell therapies is updated and published by reliable scientific authorities. However, warning signs of potential fraud were recently published:

The International Society for Stem Cell Research (ISSCR), a group of established stem cell researchers concerned with the proliferation of unproven treatments, has issued a patient handbook on stem cell therapies.

The ISSCR advises patients to seek only stem cell treatments being tested in clinical trials approved by the FDA 9or, if abroad, by a national regulatory agency such as the European Medicines Agency). It also allows for smaller studies approved by an independent Institutional Review Board (IRB) or Ethics Review Board.

The ISSCR lists these warning signs that stem cell treatment is not legitimate:

  1. It makes claims based on patient testimonials.

  2. The same stem cells are used to treat multiple diseases.

  3. The source of the stem cells is not clearly documented.

  4. How the treatment will be done is not clearly documented is a “protocol” that serves as the medical practitioner’s operating manual for the procedure.

  5. Claims there is no risk. All medical procedures carry some risk. High cost or hidden costs. Legitimate clinical trials don’t charge patients. Some even pay them to participate.

Stem cell therapies have been extensively covered in publications in the public domain, as recently documented by the Harvard University Press. Many of the unproven uses of the treatment include incurable, serious diseases, which attracts the understandable interest of desperate patients.

Medicare provides coverage for stem cell therapies under certain limited conditions, as clarified in a National Coverage Determination. Approved indications (in specified circumstances) include reconstitution therapy after treatment for leukemia, aplastic anemia, severe combined immunodeficiency, and myelodysplastic syndromes. All other clinical indications are nationally non-covered.

More information for whistleblowers is located at the Nolan Auerbach & White website.