Is stem cell therapy regulated?

Louis A. Cona, MD
Updated on
Sep 5, 2022

minute read

This post aims to explore the processes behind stem cell regulation.

Learn more about stem cell therapy and the science behind it.

Stem cell therapies have advanced in recent decades and have only begun to enter the mainstream, as many are seeking alternative treatments to major ailments. However, prior notions about stem cells and their still experimental nature have led to tight regulation and restriction concerning their use. Many are still unsure or unaware of what exactly the regulations are concerning stem cell usage. Laws vary from nation to nation and have caused thousands of patients to seek treatment from centres all around the world.

Are stem cells regulated in the United States?

Beginning in the 1970s, the US Government began heavily regulating the use of human embryos for research purposes. As stem cells were largely seen to be derived from fertilized embryos, called embryonic stem cells, the use of stem cells was largely seen as an unethical practice. Since then, advances in medicine have led physicians to sources of stem cells other than human embryos. Stem cells can now be harvested from a patient's fat tissue (adipose), from donated umbilical cords, and even donated from other patients. Despite the more ethical sourcing of stem cells, their usage in the United States has not been allowed to spread. 

Some treatments are available within the US, they are heavily regulated, only allowed for very specific usages, and only in their lowest effective dosages. Moreover, recent reports from the FDA have shown their desire to further restrict what treatments are available for patients in the US, not showing hopeful signs for the future. This is despite hundreds of studies showing the positive effects of stem cell therapy and little to no shown negative reactions.

Is stem cell therapy governed worldwide?

Although restrictions remain tight in the US, other first world nations have allowed treatments to develop. The therapies shown to be most effective from umbilical cords, due to the high number and potency of stem cells, are authorized for use internationally. Laws still vary from country to country; however, many patients have begun traveling abroad to receive the best form of stem cell treatment available. There have been several high profile cases in recent years, with Peyton Manning traveling to Germany to receive treatment on his spine, and Mel Gibson heading down to Panama to treat his shoulders. This drive has created an emerging market for medical tourism. 

With available stem cell treatments, medical centers have begun competing to offer prospective patients a better experience for their money. What was once a trip to receive medical care has become a full-fledged destination experience, complete with paradise locations, luxury fittings, and first-class customer service.

Note: This post is intended to provide general information about regenerative medicine, and related areas. All content provided in this blog, website, or any linked materials, including text, graphics, images, patient outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you.

About the author

Louis A. Cona, MD

Medical Director | DVC Stem

Dr. Cona has been performing stem cell therapy for over 12 years. He is a member of the World Academy of Anti-Aging Medicine (WAAAM). He is also a recognized member of the British Medical Association, the General Medical Council (UK), the Caribbean College of Family Physicians, and the American Academy of Family Physicians. He is the Medical Director for DVC Stem a world-renowned stem cell therapy clinic located in Grand Cayman.

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