Stem cell science is moving forward rapidly, with potential therapies to treat intractable human diseases on the horizon. Clinical trials are now underway to test the safety and effectiveness of stem cell–based treatments for blindness, spinal cord injury, heart disease, Parkinson’s disease, and more, some with early positive results. A sense of urgency drives the scientific community, and there is tremendous hope to finally cure diseases that, to date, have had no treatment.
But don’t believe everything you hear about stem cells.
Advertisements and pseudo news articles promote stem cell treatments for everything from Alzheimer’s disease, autism and ALS, to cerebral palsy and other diseases. The claims simply aren’t true--they’re propagated by people wanting to make money off of a desperate and unsuspecting or unknowing public. Patients and their families can be misled by deceptive marketing from unqualified physicians who often don’t have appropriate medical credentials and offer no scientific evidence of their claims. In many cases, the cells being utilized are not even true stem cells.
What to Believe?
Advertisements for stem cell treatments are showing up everywhere, with too-good-to-be-true claims and often a testimonial or two meant to suggest legitimacy or efficacy. Beware of the following:
• Claims that stem cell treatments can treat a wide range of diseases using a singular stem cell type. This is unlikely to be true.
• Claims that stem cells taken from one area of the body can be used to treat another, unrelated area of the body. This is also unlikely to be true.
• Patient testimonials used to validate a particular treatment, with no scientific evidence. This is a red flag.
• Claims that evidence doesn’t yet exist because the clinic is running a patient-funded trial. This is a red flag; clinical trials rarely require payment for experimental treatment.
• Claims that the trial is listed on ClinicalTrials.gov and is therefore NIH-approved. This may not be true. The Web site is simply a listing; not all are legitimate trials.
• The bottom line: Does the treatment sound too good to be true? If so, it probably is. Look for concrete evidence that the treatment works and is safe.
Hundreds of clinics offer costly, unapproved and unproven stem cell interventions, and patients may suffer physical and financial harm as a result.
A Multi-Pronged Approach to Deal with Bad Actors
The International Society for Stem Cell Research (ISSCR) has long been concerned that bad actors have co-opted the hope and promise of stem cell science to prey on unsuspecting patients and their families.
We read with sadness and disappointment the many stories of people trying unproven therapies and being harmed, including going blind from injections into the eyes or suffering from a spinal tumor after an injection of stem cells. Patients left financially strapped, with no physical improvement in their condition and no way to reclaim their losses, are an underreported and underappreciated aspect of these treatments.
Since late 2017, the Food and Drug Administration has stepped up its regulatory enforcement of stem cell therapies and provided a framework for regenerative medicine products that provides guidelines for work in this space. The agency has alerted many clinics and centers that they are not in compliance and has pledged to bring additional enforcement action if needed.
A Multi-Pronged Approach to Deal with Bad Actors
In recent weeks, a federal judge granted the FDA a permanent injunction against U.S. Stem Cell, Inc. and U.S. Stem Cell Clinic, LLC for adulterating and misbranding its cellular products and operating outside of regulatory authority. We hope this will send a strong message to other clinics misleading patients with unapproved and potentially harmful cell-based products.
The Federal Trade Commission has also helped by identifying and curtailing unsubstantiated medical claims in advertising by several clinics. Late in 2018 the FTC won a $3.3-million judgment against two California-based clinics for deceptive health claims. And just this week, Google announced a new policy that bans advertisements from unproven stem cell clinics and other speculative medical interventions. This policy is much-needed and will hopefully stem the marketing of unproven products, which are a threat to public health.
These and other actions are needed to stem the tide of clinics offering unproved therapies and the people who manage and operate them.
Improving Public Awareness
We’re hopeful that the FDA will help improve public awareness of these issues and curb the abuses on ClinicalTrials.gov, a government-run Web site being misused by rogue clinics looking to legitimize their treatments. They list pay-to-participate clinical trials on the site, often without developing, registering or administering a real clinical trial.
The ISSCR Web site A Closer Look at Stem Cells includes patient-focused information about stem cells, with information written and vetted by stem cell scientists. The site includes how and where to report adverse events and false marketing claims by stem cell clinics. I encourage you to visit and learn about what is known and unknown about stem cells and their potential for biomedicine.