Is Creska an off the shelf regenerative medicine product with living cells that is legit?
Is there an off the shelf regenerative medicine product with living cells that is legit in the USA?
*The Final (Current) Story On Using And Advertising Orthobiologics Legally In The USA
-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 orthobiologicsCan A Doctor Advertise Platelet Rich Plasma Treatments? Is PRP a Drug?
*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)Critical Regenerative Medicine/Orthobiologics Webinar Monday 6/14/21
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.Allograft Orthobiologics Wall Of Shame
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 are biologic drugs and not cleared for sale OR use in the USA
* 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.
FDA Confirms that Wharton’s Jelly products are biologic drugs….must be registered as such!
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.
Mounting legal problems for clinics using fat/adipose stem cells in orthopedics
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.
