StemGenex Comments on FDA Docket to Support Stem Cell TherapyNovember 29, 2016
LA JOLLA – November 29, 2016 – StemGenex recently submitted comments to the Food and Drug Administration (FDA) docket on the future regulation of adult adipose-derived stem cell treatments, “Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products.”
StemGenex is dedicated to ensuring that people with unmet clinical needs have access to safe and effective stem cell treatment. We believe that a collaboration between the FDA and existing accrediting organizations can result in a regulatory pathway that ensures patient safety while simultaneously accelerating access to stem cell treatment for patients.
Dr. Steven A. Brody, Chief Scientific Officer of StemGenex said, “the FDA’s future regulation of stem cell treatments is a topic of considerable interest throughout the U.S.”
“The future regulatory pathway for stem cell therapies is vital for patients who feel they have run out of options, said Dr. Brody. “There are many different opinions regarding the regulation of stem cells and we hope the recent public hearing and thousands of submissions to the FDA docket will demonstrate the overwhelming demand for access to life-altering stem cell treatments.”
The FDA’s current Guidances relating to HCT/P’s (Human Cells, Tissues or Cellular or Tissue-Based Products) propose that adipose-derived stem cells from a patient be regulated in the same manner as a manufactured drug. The approval process for a new drug can take 10 to 15 years and cost a minimum of tens of millions of dollars. If the Guidances are finalized as they are currently written it will delay access to stem cell therapies in the United States and cause many Americans who are struggling with degenerative disease to seek treatment outside of the country.
StemGenex proposes that adult adipose-derived stem cell therapies be regulated within the same comprehensive standards of organizations such as the American Association of Blood Banks (AABB). The AABB standards are recognized nationally and internationally and are based on the core principals of quality, scientific research and patient safety. Organizations such as the AABB have successfully set standards for the safe use of blood and tissue products for over 20 years. Ideally, the high standards of accrediting organizations such as the AABB are suited to guide and monitor the safe use of adipose-derived stem cells.
StemGenex is also in support of stem cell research, treatment providers, and clinics being required to be registered on a National Directory. The development, participation and designated requirements of such a clinical registry would provide a reasonable alternative to regulating adult adipose-derived stem cell treatment as a drug.
“Stem cell therapies are one of the most promising areas for the next generation of treatments,” said Chief Administrative Officer Rita Alexander. “The availability of these therapies is imperative for people battling these devastating diseases.”
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.