House Committee Raises Concerns with FDA Over Stem Cell Products
What prompted this Blog subject matter is an inquiry I received from a colleague concerning the use of Stromal Vascular Fraction (Adipose Derived Stem Cells) as an injection option for an arthritic knee. I know something about this alternative as I am an investigator in PSC-CP-001, a Current Clinical Trial for which we will soon be announcing enrollment. The benefits from participation in this trial is 1) your cells are quality tested before use 2) Processing meets FDA standards 3) The clinical trial is approved by the FDA 4) Storage of stem cells for potential future use without another fat collection 5) treatment is offered in the US.
On July 25, the House Energy & Commerce (E&C) Committee sent a letter to the Food and Drug Administration (FDA) outlining concerns over the slower than expected rate of compliance among manufacturers and providers of stem cell therapies. At least 20 manufacturers and providers who may be offering unproven stem cell therapies have already received letters from the FDA. In 2018, the agency filed injunctions against two clinics to stop the marketing of unproven and unregulated stem cell therapies. Now the FDA has until August 15 to address the Committee’s questions, including how it is coordinating with other state and federal agencies. AAOS continues to monitor the FDA’s actions on stem cells and to share information that helps members comply with the evolving regulations governing these therapies. Read E&C Committee’s letter to the FDA…
The letter from The Congress of the United States, House of Representatives, Committee on Energy and Commerce is a must read -ctrl+click on that in red above will get you there-and you will learn how those victimizing an uninformed public and those uninformed or misinformed physicians will soon pay a severe price. Our Trial to the contrary, Personalized Stem Cells, Inc (“PSC”), a human adipose-derived stem cell company, has received FDA approval for a New Drug (IND) application for use of a person’s own adipose-derived stem cells to treat their osteoarthritis. The first clinical trial, expected to begin in several weeks, uses stem cells as a treatment of osteoarthritis in the knee.
This is the first of several planned clinical trials which will enable qualified PSC-enrolled physicians to provide FDA compliant, regulated quality cell therapy to patients suffering from osteoarthritis. PSC plans to conduct a series of FDA approved clinical trials starting with uses in orthopedics and expanding to other medical conditions in the future.
PSC is working with the FDA to provide alternatives to unregulated, in-clinic stem cell processing and unapproved “regenerative” therapies. The current environment of in-office, unregulated manufacturing of stem cells by physicians has come under serious regulatory action by the FDA, FTC, and the Federation of State Medical Boards. It is clear that the only allowed use of stem cells will be through legitimate FDA clinical trials with manufacturing in a controlled FDA inspected, GMP compliant facility.