Unproven Stem Cell “Treatments”

Stem cell research is an active field with the potential to help identify new therapies that may be able to repair or replace damaged cells or tissues. At this time there are very few conditions for which stem cell-based therapies are proven and widely accepted by the global medical community. These are primarily limited to blood stem cell transplantation to treat diseases of the blood, such as leukemia and sickle cell anemia. Although research is ongoing, stem cell-based treatments for most other conditions are experimental and have not been shown to be safe and effective.

Beware of ‘Snake Oil’

Perhaps you’ve heard of “snake oil,” which comes from the 19th century practice of advertising a single elixir as a remedy for all sorts of ailments without clear evidence of quality or health benefit. Unfortunately, false advertising and exaggerated claims are still a problem, and unproven stem cell “treatments” are among the miracle cures being sold today. Be aware of these things to know if you are considering a stem cell treatment.

An unproven stem cell “treatment” is an experimental treatment that is new, untested, or different from standard medical treatment and has not undergone the proper regulatory process. This is in contrast with investigational treatments which are being tested in clinical trials with proper regulatory oversight, and approved stem cell treatments that have been shown to be reasonably effective and safe for treating a particular disease or condition through a formal, regulated process of clinical trials.

The fact that a treatment is experimental does not automatically mean that it is part of a research study or clinical trial. Patients should be aware that many stem cell clinics and providers are currently marketing and administering unproven stem cell “treatments,” which are not supported by valid science and have not been shown to treat the particular disease or be safe.

Before a stem cell therapy should be considered for use, it requires clinical trials and a rigorous peer review process to show that it is safe and effective. Individuals undergoing unproven treatments are taking on physical and financial risk as with any medical procedure, even if the treatment uses one’s own cells.

The marketing of unproven stem cell treatments raises major ethical and integrity concerns and may jeopardize the safety of patients. The International Society for Stem Cell Research (ISSCR) engages in global advocacy efforts to ensure the integrity of stem cell science and its translation to medicine.

We strongly encourage patients and their families to discuss any treatment they may be considering, including an experimental treatment, with a physician who is familiar with their individual circumstances and able to critically assess the experimental treatment and clinical trial.

Did you receive an informed consent or treatment consent form?