Is stem cell therapy regulated?

Louis A. Cona M.D.

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

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 centers 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.

3 DAYS POST TREATMENT

Tyler explains his experience at DVC Stem in the Cayman Islands.

Tyler is optimistic that he will see positive results post treatment.

"The cool thing about the Cayman Islands besides being beautiful, it was an opportunity to get some rest and relaxation allowing my body to heal and restore. I'm back in the US now and feel like I am ready to conquer the world."

- Tyler Heid

2 WEEKS POST TREATMENT

2 weeks post treatment, MS patient Tyler is beginning to see amazing progress. He has been wheelchair bound for the last year and has not been able to move his legs unassisted before now.

2 MONTHS POST TREATMENT

Tyler updates about his progress, explaining the amazing response he has been receiving from his friends and family.

"People coming up to me saying I am moving, talking and smiling so much better. They are noticing a lot of things that have improved over the course of 3 months."

"This morning I was able to do things that I was unable to do before, I was able to stand up and lift my leg higher than I ever have before."

5 MONTHS POST TREATMENT

5 months post treatment Tyler sends us an update on his progress.

"I'm able to smile better, I have more control over the left side of my face."

"I have an increased ability to grip, lift my legs higher and higher which has gone well."

Tyler is optimistic and on the right track to recovery. We are ecstatic to see his progress and look forward to more updates from him.

"I have an increased ability to grip, lift my legs higher and higher which has gone well."

Tyler Heid - 5 months post treatment

David Lyons

Multiple Sclerosis

Although David Lyons was able to successfully fight Multiple Sclerosis through a strict regimen of diet and exercise, he wanted to ensure he was doing everything he could to stay fit. Multiple Sclerosis can be managed with treatment, but there is currently no cure for the disease. For that reason, David came to DVC Stem years ago to use the regenerative and anti-inflammatory attributes of stem cells to aid in his fight for fitness.

The positive results he experienced enabled David to stay strong in the gym, now into his 60s, and that is why he continues to support our clinic to this day.

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