*2024 FDA Untitled Letters and what it means for Orthobiologics*
In 2024, there have been 5 Untitled Letters sent out for regulatory noncompliance with biologics. Untitled letters typically give the company or person a chance to correct the variance before any further FDA regulatory action and clearly show the current FDA regulatory stances on various orthobiologics.
Here is 9 year followup from one of the youngest patients I have treated with bone marrow concentrate for a partial ACL tear.
He also had a displaced medial meniscus tear that needed to be repaired so I did that surgically.
After several discussions, the parents, the patient (he was 14 years old) and I all agreed to inject the ACL with BMC.
We were hoping to avoid ACL reconstruction and the potential future arthritic changes that often occur after that surgery, especially when done in a 14 year old
Join us on September 10, 2024, as we welcome Don Buford, MD, from Texas Orthobiologics, and hosted by Amit Momaya, for a Grand Rounds lecture to discuss "Evidence Based Orthobiologics From A-Z."
At Texas Orthobiologics we use a hematology machine to quantify the PRP doses and concentrations we are giving patients. We have an abundance of high level clinical data giving us dosing parameters (from hematology machines) for various orthopedic conditions. It isn't perfect but it is the best we can do in the office at the point of care. Likewise, getting a cell counter so we can determine a total nucleated cell count for a bone marrow concentrate(BMC) procedures make sense. But TNCC also has limitations.....TNCC doesn't directly correlate with the actual MSC or HSC count....but it is a good proxy same day metric for quantifying BMC procedures
This is a 10 minute review on why we need stem cells as a treatment option for knee arthritis.
The talk includes the most recent evaluation of the clinical literature supporting bone marrow, adipose, and bone marrow concentrate as stem cell treatments for knee osteoarthritis.
No need to go to Columbia, Mexico, Costa Rica, Honduras, etc.....until the critical clinical research supports spending 3x-5x more money for the exact same outcomes
Call us for an unbiased eval and personalized treatment options! 877-777-8883
texasorthobiologics.com
PRP is a good treatment option for tennis elbow. Research for using platelet rich plasma is over 10 years old.
I think that a single higher dose PRP injection eliminates the need for a second injection for tennis elbow most of the time. High dose would mean a 60cc blood draw and getting the platelet dose definitely above 3.5 billion and more likely up around the 5 billion range in a 3cc-4cc PRP injection. Platelet count in the PRP would be a 1200-1500 depending on the patient's starting platelet count.
We have many non-steroid alternatives for joint pain and inflammation:
Laser, Shockwave, Platelet rich plasma, bone marrow concentrate, micro-fat, toradol, cryoneurolysis....all come to mind as treatment options without this documented risk of increasing infection rates or potentially accelerating degenerative changes. Other than the cryoneurolysis....none of these are "destructive" and many have documented long term benefits measured in years!
For this patient the best and most predictable long term outcome was to stabilize the shoulder arthroscopically.
For the majority of our orthopedic patients....we can avoid surgery while getting them back to doing the things they love with less pain! Call us for an in person or telemed consult. Check our bio!
s a doctor or patient if the end PRP is the same, would you rather have 30cc or 60cc drawn? 180cc or 60cc? 240cc or 60cc? There are tremendous differences in platelet recovery percentage between PRP kits and homemade protocols. If we only care about the platelet concentration....then the chart below shows one PRP kit's data starting with a whole blood platelet count of 250. The bottom chart shows a more efficient protocol than the top chart....this commercially available kit can create 20x PRP in 2.5cc from a 60cc blood draw! Platelet dose is 12.5 Billion in this example. There are other commercially available kits that would require a blood draw of 180cc (or more!) of blood to get to the same concentration and platelet dose.
The platelet recovery percentage of your system is an important Platelet Rich Plasma metric!
Happy Father's Day Dad!
most don't know that towards the end of dad's career in 1975 he had a near total medial menisectomy in Japan. Today it would have been a meniscal repair.... He went on to have a TKR about 19 years ago by the great Dickie Jones, MD in Dallas....still going strong on the original TKR! The other knee has KL4 changes and enough varus to make an arthroplasty surgeon blush BUT dad does great with high dose intra-articular PRP injections every 6-9 months...no downside.
