LA JOLLA – September 20, 2016 – “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 held on September 12 and 13, 2016, at the National Institutes of Health (NIH) located in Bethesda, MD.
The purpose of the public hearing was to obtain comments on four Draft Guidances of Human Cells, Tissues and Cellular and Tissue-Based Products relating to the regulation of adult stem cell therapies. The event was heavily attended by nearly 500 attendees and 90 speakers which included national health care professionals, researchers, accrediting organizations, and patients. Representatives of StemGenex were overwhelmed by the heartfelt testimonials from patients who have had their lives changed by adipose-derived stem cell treatments.
A majority of the speakers advocated for continued access to safe and effective adult stem cell therapies. Others advocated for adult stem cells to be regulated as a drug, which could potentially delay patient access to life-changing therapies. The regulatory pathway to market a new drug is a very long process, which under the best circumstances can take 10 to 15 years at a cost of tens of millions of dollars.
In his presentation, Dr. Brody asked the FDA to consider the following changes as they finalize the guidances:
- Recognize the structural and non-structural properties of adipose tissue.
- Review and expand the definition of minimal manipulation.
- Regulate human cells, tissues and cellular and tissue-based products in the same manner as blood tissue products within the existing comprehensive standards of organizations such as the American Association of Blood Banks (AABB).
“Organizations such as the AABB are ideally suited to safely guide and regulate the use of adipose-derived stem cells,” said Dr. Brody. “The AABB established regulatory framework would require stem cell treatment centers to meet standards that would ensure public safety.”
Amending the draft guidances as related to the above recommendations would be a positive step towards providing medical professionals with the ability to offer their patients an option where there is little hope for unmet clinical needs.
“StemGenex will tirelessly 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.