-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
Don Buford, MD is an orthopedic surgeon and regenerative medicine expert who specializes in the best way to get patients back to health in the fastest, safest way possible!
The 2021 Las Vegas MSK Ultrasound And Orthobiologics Course
July 29-31, 2021 at the Cosmopolitan Hotel
www.orthosono.com
Las Vegas MSK Ultrasound and Orthobiologics Course is back!
July 29-31, 2021 at the Cosmopolitan Hotel
www.orthosono.com
*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)
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 is starting to get even more aggressive in enforcing their HCT/P regulations. The FDA statement yesterday makes it clear that what many of us have been saying for years is in fact true. #1 Stem cells, SVF, umbilical cord blood, amniotic fluid, Wharton’s Jelly, exosomes, and orthobiologics are all considered biologic drugs and ALL are improperly registered under section 361 for orthopedic applications.
*When is a level 2 scientific study NOT a level 2 scientific study?*
Answer: When it is a retrospective review of an insurance company database.
A recently published 2021 study by Dr. James Pritchett, is titled “The debit side of stem-cell joint injections: a prospective cohort study” and is listed as a Level 2 study by the journal…Current Orthopedic Practice.
just received our monthly report from Web MD and Healthgrades These websites are the two of the largest websites with verified reviews from real patients…..and we care that we are providing good orthopedic and regenerative medicine care. We have 391 5 star reviews on Web MD and 377 5 star reviews on Healthgrades.com Thanks sincerely to our patients for helping us fine tune our practice to serve them.
Chris Centeno, MD, founder of Regenexx and past President of the Interventional Orthobiologics Foundation, has collated and linked worldwide research on bone marrow stem cells. Each circle in the pic represents a hyperlink to the article! This amazing project shows the explosive research interest in bone marrow derived stem cells for many clinical uses.
