*Two Orthobiologic Questions*
#1 Is PRP (platelet rich plasma) considered a drug (or HCT/P)? NO
#2 Can a doctor advertise PRP treatment for orthopedic conditions?*
Yes, as long as the advertisement is based on accepted medical evidence (ie. studies showing beneficial human outcomes)
This is just my opinion :) (Based on some solid data though)
*Two Orthobiologic Questions*
The Interventional Orthobiologics Foundation is having a free webinar this coming Monday night, 6/14/21 at 6pm Pacific and 9p Eastern.
*What does the recent FDA Consumer Alert on Orthobiologics mean for Doctors, Manufacturers, and Patients?*
The panel has over 100 years combined experience in regenerative medicine AND in direct dealings with the FDA and other regulatory authorities. Sign up and listen to Andrew Ittleman Esq., Scott Bruder, MD, PhD, and Matthew Murphy, PhD as they interpret the current regulatory state of regenerative medicine in the USA.
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.
* 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.
A 45 min. talk on the 2019 Current USA Regulations for Stem Cells and the regulatory and legal actions
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.
The FDA just won a summary judgement against adipose tissue clinics under the umbrella of US Stem Cell
A federal court just affirmed the FDA’s claims and injunction against against US Stem Cell and two of its employees/principals.
The Park Avenue Stem Cell clinic is a former Cell Surgical Network affiliate which is a network whose founders (Drs. Mark Berman and Dr. Elliot Lander, are currently entangled with their own legal struggles with the USA Justice department over their stem cell clinic claims and activities.
FDA Just Reaffirmed That You Can’t Use Umbilical Cord Blood in Orthopedics Without A Drug License Or Specific Permission Thru a RMAT Or Other FDA Program
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).”
Ok, just kidding, FDA doesn’t endorse any stem cell sources….BUT the FDA doesn’t regulate bone marrow as a stem cell source when used in orthopedics and they DO regulate adipose(fat), amniotic fluid, umbilical cord blood, placental tissues, and other stem cell sources used in orthopedics as biologic drugs. So, stick with the one source that is given the “top-line” exemption for use by the FDA. Here is a 15 minute video on why the FDA doesn’t regulate bone marrow in orthopedics.