The Promise

It is all too common today to come across ads declaring that stem cells can cure your [insert disease/condition here]. In fact, these marketing claims made by so-called “stem cell" clinics are everywhere: in newspapers, on billboards on your way to and from work, on the television and radio, and littered all over the internet. “Suffering and in pain? Have you heard of stem cells? Come by our clinic today— bring money.”

The Reality

In reality, there are currently very few stem cell treatments that are both proven safe and effective and/or approved by regulatory authorities, most of which involve the transplantation blood stem cells (such as bone marrow transplants) to treat certain blood and immune system disorders and some blood cancers. However, this fact has not stopped nefarious stem cell clinics from preying upon suffering and desperate patients by falsely marketing their own stem cell “treatment” as a silver bullet for any and all diseases, despite the absence of any scientific rationale supporting their approach and evidence of their safety or effectiveness. The growth of unethical stem cell clinics is a worldwide phenomenon, including a concentration of 716 clinics in the US alone. Importantly, the unproven “therapies” provided by bad-acting clinics can have exorbitant costs to both your finances and health.

What do you have to lose?

After having undergone unproven stem cell interventions, which can cost thousands of dollars, many patients discover they have not gained any medical benefit to accompany their bill.  Even worse, these “treatments” can have very real negative health repercussions. Numerous adverse events from unproven interventions have been reported in the press, ranging from mild to severe infections, to blindness, and even tumors (including one on a patient’s spine).

What you can do

Importantly, regulatory agencies in countries around the world, including Heath Canada, Australia’s Therapeutic Goods Administration , and the US Food and Drug Administration, have strengthened their regulations or stepped up their enforcement of clinics selling unapproved therapies. There are also actions you can take to support these efforts. Whether you have experienced medical harm from these interventions or are simply outraged by the injustice of false marketing claims of stem cell clinics, there are proactive steps you can take to help fight bad acting clinics.

Reporting false marketing claims and adverse events to regulatory agencies

The ISSCR has recently published an online guide on How to Report False Marketing Claims and Adverse Events from Clinics Offering Unapproved Stem Cell “Therapies” for several countries around the world. This resource includes contact information and direct links for submitting reports to medical regulatory boards, marketing and commercial trade regulators/oversight committees, and governmental health regulators. The list of countries with actionable links will continue to grow. If you have additional actionable links for countries not currently listed on that webpage, you can contact the ISSCR (cbarry@isscr.org).

Make sure you are part of an informed consent process before undergoing treatment

Recently, the ISSCR released a Professional Standard for Informed Consent for Stem Cell-Based Interventions meant to help ensure patients know what information should be disclosed to them prior to undergoing unproven stem cell “therapies.” Specifically, clinicians are required to adequately inform patients about the potential risks and benefits of the procedure before proper informed consent can be given. The new ISSCR standards can be used as a resource to gauge what constitutes proper informed consent and what information should be ethically provided preceding any stem cell-based intervention.

Educate yourself and others about red flags of stem cell “treatment” claims

The ISSCR has developed several important resources to help inform the public about the current clinical outlook of stem cell therapies and help spot unproven or unapproved therapies. These resources, located on the A Closer Look at Stem Cells webpage, include What to Ask, Nine Things to Know About Stem Cell Treatments, the Patient Handbook, and overviews of the current state of stem cell research relevant to several diseases.

Clinics selling unproven and unapproved stem cell “therapies” are an international problem and regulatory agencies have had difficulty keeping up, but the momentum is slowly shifting. There is a wave of increasing vigilance against these clinics and enforcing the laws that protect patients from them. And you can help.