How to Report False Marketing Claims and Adverse Events from Clinics Offering Unapproved Stem Cell “Therapies”
The marketing and administration of unproven and unapproved stem cell treatments raises major ethical concerns and jeopardizes the safety of patients. These treatments, which are often sold under the guise of cutting-edge advances, have not been shown to be safe and/or effective and have not received regulatory approval. The list of diseases for which stem cell treatments have been proven to be beneficial and/or have obtained regulatory approval for use is still very short:
- The transplantation of hematopoietic (or blood) stem cells (such as bone marrow transplants) to treat certain blood and immune system disorders, and to rebuild the blood system after treatments for some kinds of cancer.
- Specific genetic modification of one’s own blood stem cells to treat beta-thalassemia or gene therapy of immune system cells for the treatment of certain blood cancers.
- Some bone, skin and corneal (eye) injuries and diseases can be treated by grafting or implanting tissues in which stem cells are essential for the healing process.
As of 20 June, 2019 other applications of stem cells have not yet been proven safe or effective for patient use through clinical trials and have not been approved for use by regulatory authorities. Claims that stem cell interventions can treat or cure diseases other than those mentioned above should be approached with skepticism, and claims that these treatments are approved by proper regulatory agencies, or that they don’t need regulatory approval, are likely to be untrue.
Several countries are now strengthening their regulatory oversight of cell and tissue products to rein in unscrupulous clinics marketing unproven stem cell “therapies.” However, clinics around the world continue to provide unproven stem cell treatments and often market them as cures for a variety of diseases and conditions without sound scientific evidence or regulatory approval. These so-called treatments have, in some cases, caused patients great harm physically, and at great expense financially.
If you were harmed by a stem cell “treatment” or encounter clinics offering suspicious stem cell “therapies” that you suspect may not be approved by the FDA or other national regulatory agencies, you can report clinics and practitioners involved to the proper authorities. More information about reporting in certain countries is listed below.
More information about warning signs of unproven stem cell treatments is available on A Closer Look at Stem Cells.
Australian Department of Health, Therapeutic Goods Administration (TGA)
You may send the TGA complaints about false advertising and adverse outcomes from the administration and marketing of unproven medical products.
Report a concern to Health Canada if you suspect a clinic is advertising or offering unauthorized stem cell therapies in Canada, or you want to report any adverse events you have suffered from such administrations. You can also submit official complaints using Health Canada’s Health Product Complaint Form (FRM-0317).
Unsubstantiated advertising claims for unproven stem cell products can be filed online with Canada’s Competition Bureau Complaint Form.
Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)
This agency handles complaints about the administration of unapproved cell therapies or reporting adverse events that have resulted from them.
Commerce Commission New Zealand:
The Commission has information on this site to register a complaint regarding offering unlawful therapies or making unfounded marketing claims for unproven cell therapies.
U.S. Food and Drug Administration (FDA)
The FDA has a reporting form for patients who experience adverse events related to human medical products, including unauthorized ‘treatments’ from stem cell clinics.
Federal Trade Commission (FTC)
You can submit a consumer complaint about clinics making unsubstantiated marketing claims of the stem cell products they offer.
State Medical Boards
If you live in the U.S., you may contact the Medical Board of your state, which regulates physician activities and can take actions to intervene in illegal practices.
Or, you can Report a doctor through the Federation of State Medical Boards.
The Advertising Standards Authority (ASA)
Report unproven medical claims in advertising.
As additional information becomes available from other regions of the world, the ISSCR will post it on this page.