-Clarification on terminology such as stem cells, regenerative medicine and orthobiologics
-What it means for FDA clearance vs. FDA approval
-Sage advice to surgeons, medical sales reps and patients seeking counsel on orthobiologics
I have been involved in recent discussions with patients and clinicians who were under the impression that there are stem cells in circulating blood and therefore also in platelet rich plasma. They have this impression from well known podcasts, from some doctor and chiropractic clinics, and in one case from a company still in the midst of a class action lawsuit whose business model was selling PRP as a stem cell treatment for severe pulmonary diseases (The Lung Institute).
The FDA maintains a public website of their letters sent to companies in the orthobiologic field. Every company on this slide has received some form of FDA inquiry. Some of the offenses are more egregious than others with patients blinded or given tainted product resulting in septicemia and life threatening illnesses.
There are almost too many red flags to count with the advertising of Stem Cell USA. http://stemcellusa.co
#1 The clinic lists NO doctor or health care, provider
#2 The clinic lists a wide variety of human conditions that they can treat with stem cells
This time, the company is RichSource Stem Cells, whose CEO is Sara Oracle. On November 20, 2019, the FDA sent the company a letter detailed all of the falsehoods in the claims being mad by these companies when they sell their products to clinicians….and all the falsehoods that clinicians are selling patients when then sell these products.
Does having an IRB (institutional review board) approval or a study mean that you DON'T have to abide by the FDA regulations for amniotic fluid, umbilical cord blood, exosomes, Wharton's Jelly, or anything else in regenerative medicine? NO :)
* EXOSOMES * The Final FDA Word On Exosomes For Clinical Use In The USA. A well respected and thoughtful regenerative medicine doctor and educator recently took the time to do what I have been begging distributors and makers of allograft orthobiologics to do….ask the FDA about the regulatory requirements for their products! Thru the end of this year the FDA has a program called “TRIP” that is free and results in a prelim answer in 3 business days.
45 min overview on the 2019 current FDA regulatory landscape for regenerative medicine. I also discuss the ethical concerns and recent regulatory and legal actions in the USA.
A regenerative medicine doctor (Dr. Charles Lee) recently asked the CBER division of the FDA if Wharton’s Jelly products were being correctly regulated and sold for use in humans. Guess what? The FDA said “NO”. All allograft stem cell Wharton’s Jelly products currently on the market in the USA are being sold in violation of FDA regulations. Avoid any company and ALL doctors and clinics selling this stuff. On top of it all….there is no science that it even works for human orthopedic conditions anyway. This is why we only use bone marrow derived stem cells from your own body.
FDA clearly states that umbilical cord blood is NOT exempt from registering as a biologics drug under section 351.
FDA states that “….using the umbilical cord blood products to treat orthopedic conditions is not homologous use as defined in 21 CFR 1271.3(c).”
