Nearly 100 individuals traveled from all over the United States to Washington, D.C. to speak face-to-face with the Food and Drug Administration (FDA) about the future regulation of stem cell treatment at the FDA Public Hearing on draft guidances regulating cells and tissues.
The packed public hearing, which according to the FDA’s website was “sold out” in less than one week of opening registration, was held for two full days on September 12th and 13th of this year at the National Institutes of Health. In addition to the public hearing, thousands of individuals posted their comments about stem cell therapies on the FDA online docket. Comments can be read here: “Public Hearing; Request for Comments; Correction OPEN”.
Several stem cell patients treated at StemGenex Medical Group shared their extraordinary testimonials with the FDA about how stem cell treatment has dramatically improved their quality of life and emphasized the urgent medical need to allow patients suffering with incurable illnesses, who have little or no other available treatment options, to have continued access to the amazing regenerative properties of their own stem cells.
Kristen, a 51-year-old mother of two suffering with Multiple Sclerosis got to the point where she became unable to take care of her children. Within weeks after stem cell treatment, Kristen was able to take her kids to school, help with homework and be a “normal” mom again. Kristen noted, “There are no drugs on the market to slow or cure MS,” and pleaded, “Please give me the power and capability to use my own stem cells to regenerate and help my body heal.”
Carl, diagnosed with Multiple Sclerosis in 1997 was unable to sit in a chair, bathe or feed himself due to the uncontrollable tremors and numbness in his hands and feet. After stem cell treatment, Carl could stand up, sit up for extended periods of time and independently bathe and feed himself. “I was able to tie my shoes for the first time in years. We’re in the beginning stages of stem cells being used on a regular basis. Please do not regulate my own stem cells as a drug,” urged Carl.
Tim, diagnosed with Parkinson’s Disease in 2013 had stem cell treatment at StemGenex Medical Group. “Stem cell treatment has given me a lot more energy, my focus has been much more clear and I’m back to being social again. How sad is it that the best drug for Parkinson’s on the market was approved in 1967? Let that sink in… We have been treating this disease with the same medicine for 50 years. I am asking the FDA to not overregulate the usage of stem cells and allow my chosen medical professional to have the ability to treat me as they, and I see fit,” said Tim.
“Stem cells have arrived and have captivated the scientific and medical communities. With this excitement comes responsibility and with this responsibility comes regulation,” said the Chief Scientific Officer of StemGenex, Steven A. Brody, M.D., Ph.D., in his presentation to the Food and Drug Administration (FDA) at the Public Hearing.
Given the sizeable amount of information submitted for stem cell approval that will need to be carefully reviewed and considered, the time frame for finalization of a regulatory pathway for safe and effective stem cell therapies is unknown. Amending the draft guidances, however, to allow for continued access to stem cell regulated therapies would be a positive step towards providing medical professionals and patients a viable option where there is otherwise little hope for meeting clinical needs.
In the meantime, “StemGenex will continue to advocate for stem cell treatment and access to the healing benefits of their own cells,” said Chief Administrative Officer Rita Alexander. “We believe that stem cells are key to advancing the future of medicine.”
If you or someone you know is interested stem cell treatment, visit www.stemgenex.com, or call (855) 742-STEM to speak with a Patient Advocate.