Texas Orthobiologics

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Texas Orthobiologics

* Level 1 RCT: Even Low Dose PRP is Better Than Needling For Greater Trochanteric Pain Syndrome!*
This level 1 study was done in Spain.
41 patients got low dose PRP made from a 24cc blood draw and a concentration of about 2.3X (actually platelet counts not reported) in a 5cc injection of PRP.
The platelet dose was probably in the range of 2 billion to 3.5 billion platelets in a single ultrasound guided injection.
Patients were followed for a year.
**The primary outcome measure was the Hip Outcome Score (HOS-ADL and HOS-SS) and on that metric the PRP patients were statistically significantly better at one year on the sports specific (HOS-SS) subsection only. There was no difference in outcomes in the ACL score subsection of the HOS.

I think the results of this study further support the contention that getting platelet doses above 3.5 Billion platelets in a single injection....and likely even higher than that....is necessary to show the best clinical outcomes.
Thoughts:
If we draw 60cc blood versus the 24cc blood draw in this study, the PRP dose would be higher.
If we use a single or double spin PRP system better than the single spin system used in this study...we could get a platelet concentration of 5-7x baseline instead of just 2.3X like in this study......then the PRP dose will be higher...
Ultimately, it sure seems like we need to stay above 3.5 billion platelets and based on the literature, closer to 5 billion+ platelets in a single injection for maximal soft tissue benefit.
https://journals.sagepub.com/doi/full/10.1177/23259671241249123

This short video shows an ultrasound guided injection into a partially torn rotator cuff (supraspinatus) tendon in the right shoulder.
Patients with these types of tears can often benefit from an ultrasound guided PRP injection done by a shoulder doctor. Questions? Give us a shout! Contact info in our bio.

Ultrasound guided PRP injection for partial rotator cuff tear. This short video shows an ultrasound guided injection into a partially torn rotator cuff (supraspinatus) tendon in the right shoulder.

Do #prp or stem cell injections always work for knee pain from arthritis? Not always! This video shows one example of a patient who had a injection for knee pain from arthritis. Unfortunatlely the knee pain did not get better and she cont...

*PRP is not just for humans!*
Biology works and is similar in most if not all mammals.
A recent pilot study on 6 patients revealed that a single PRP injection helped the felines with joint DJD.
Patients were followed for 6 weeks and all showed improvements in Feline VAS and Feline Musculoskeletal Pain Index (FMPI).

Ready for the last word on Rotator cuff calcific tendinopathy, needling, barbotage, injections, and surgical options? We have a webinar for you next Thursday at 5p PST, 7p CST, 8p EST
The Q&A session is open for Regen Med questions on all topics!

Register here for free:
https://us02web.zoom.us/webinar/register/WN_sSqd4BlVTJSVikYhH8bo6g

* PRP Success TIP*
For soft tissue pathology, get your PRP dose above 3.5 Billion platelets in a single injection IF you want to get a positive response. In our paper we documented 14/14 papers with platelet doses below 3.5 billion platelets did not help patients! on the other hand, 9/11 papers with doses above 3.5 Billion platelets DID help patients! So....check your platelet dosing or make sure somehow that you are above 3.5 billion platelets. The easiest way to be relatively sure if you can't test your doses? Draw 60cc of blood and concentrate down to whatever PRP end volume is appropriate for the area being treated.

I am not sure it is possible to sum up the current state of PRP use in orthopedics better than Peter Everts, PhD did recently.

He is the lead author on this paper as well:
Angiogenesis and Tissue Repair Depend on Platelet Dosing and Bioformulation Strategies Following Orthobiological Platelet-Rich Plasma Procedures: A Narrative Review

The link for the paper is here: https://www.mdpi.com/2227-9059/11/7/1922

*Does help with recovery or healing?*
(Spoiler alert: Look at the PRP dosing!)
According to a recently published study in JAMA, adding PRP to an autologous hamstring double bundle anterior cruciate ligament reconstruction made no difference in recovery at the 1 year mark post surgery.
This level 1 study protocol had two groups.
The treatment group received 3 PRP injections over the first 3 months after surgery. The control group received no PRP.
There was no significant difference in KOOS scores at any time point out to one year.
SO, is that the end of the story here? I don't think so.
The platelet dose in this study averaged 3.4 Billion platelets (678 Plt x 5cc PRP) which is on the low side for sure. We routinely give PRP doses 3-4 times higher in the office when treating knee symptoms. The PRP treatment group trended higher in this study....so maybe the dose is just too low...or maybe there were not enough injections or the interval was off in some other way.

The easiest initial next step would be to see if the outcomes became significant if the dose was tripled to 10 Billion. Anyone takers for a multicenter ACL + PRP trial at PRP dose of 3 x 10 Billion platelets?

Anyone interested in a doctor level presentation appropriate for general public too (15min) on how doctors should be dosing for and knee and ....here is the free link!
NO sales...not asking for anything 🙂 Just free info.
https://youtu.be/l0AehXr8Z4E
https://youtu.be/l0AehXr8Z4E

QR code is a link to the latest handout from an upcoming talk on office injection options for knee arthritis! Hot off the press and free for anyone interested in the latest research and clinical uses for , from bone marrow aspirate and sources too. is definitely here to stay and the high level clinical research is growing daily!

How to Aspirate Bone Marrow For Regenerative Medicine Procedures (2024 AOAO Talk) This 8 minute presentation was first given by Don Buford, MD at the Spring AOAO meeting in Las Vegas in 2024. Don Buford MD is the founder of Texas Orthobio...

*Creska? An off-the shelf adipose product with living cells registered under FDA section 361? Questions pop to mind...*
Q> Have I seen a regenerative medicine company claim that I should use their product in orthopedics and that their product has living cells before? Despite being frozen, shipped and then immediately thawed in a my office?
A> Yes... And subsequent independent publications proved those claims of living cells to be 100% false
(https://lnkd.in/g8BmzwSv)
Additionally, the FDA sent out more Warning and Untitled Letters to companies marketing those products to take them off the market than I can remember to count (plus what happened in 2021)
Now we have "Creska™"
The company claims:
#1 "Creska is an FDA Compliant Live Cellular Adipose Derived Allograft that can be used subcutaneously, in the dermis or topically where skin or fat naturally exists to act homologously..."
#2 "Creska™ meets all the criteria established by the U.S. FDA for HCT/Ps that are regulated solely under Section 361 of the PHS Act, and subject to 21CFR 1271."
#3 "Creska™ is not intended for transplantation and is not HLA type matched between a donor and a recipient for any type of transplantation or intravenous use. .. Mismatched donor and recipient tissues can lead to rejection of the tissues. Creska™ is strictly for topical, cosmetic and subcutaneous use. This product is not intended for use in the treatment of any disease or condition.

The company clearly has no "on-label" FDA approved indication and they have registered the product under the free, "scout's honor", 30 minute, on-line FDA section 361 pathway. So, how could I use this in orthopedics? I don't know.
The company's claim of having a living cellular product would seem to automatically make their product regulated under section 351. I say that only because I have heard FDA officials say that in public forums and webinars over the past 5-8 years.....especially when amniotic fluid companies and Wharton's jelly companies and Placental tissues companies used to claim they had living cells in their products. The FDA has stopped companies from selling cosmetics with claims of living stem cells before!
Why would Creska not also be a misbranded and misregulated section 361 product claiming live cells?
I am not an attorney and I don't work for the FDA.....so ask the your health care regulatory attorney and the FDA for their opinion on this new product claiming to have living cells in an off the shelf allograft adipose product.

By their own web site.....it shouldn't be used any deeper than subcutaneously anyway 😉
And all of this before we even have safety data (oand obviously no outcomes data!!!) on human orthopedic uses....so there is no way I could use this product over PRP....and to use it with PRP would likely make my PRP run afoul of the FDA too!! DYOR.
hashtag hashtag hashtag hashtag

The FTC is voting on the 23rd on the issue on noncompetes in contracts....potentially affecting thousands and thousands of physician/hospital contracts....physician group contracts.....and company/representative contracts.
Get your popcorn ready!
https://lnkd.in/gqsAR2NV

* Bench Test Of the Globus/Harvest Medical Smartprep3 60cc Kit*

If you are in at all you have heard of Globus Medical. Back in 2022, Globus expanded their Biologics with the acquisition of Terumo (Harvest PRP). Some friends came by with a couple 60cc Smartprep3 PRP kits and we tested them in our lab setup.
Protocol: 56cc blood draw to which 4cc of ACD-A is added.
2cc ACD-A put into the blood container. It is essentially a two spin protocol with a 4 min first spin followed by a 10 min second spin. Harvest is a bit unique in that the clinician doesn't have to do anything between the first and second spin...the centrifuge just slows down enough for the container to transfer some blood and plasma over and then the second spin starts back up.
RESULTS (we did two identical trial runs)
Platelet recovery percentage average: 85%
Avg. Platelet dose from 56cc blood -->> 6 cc PRP: 8 Billion
Average starting platelet count: 169 Avg PRP count: 1340
Average Concentration Factor: 7.9X
This was a very leukocyte rich PRP.
Avg. WBC from 4.6 in blood to 34 in PRP (7.4x incr. in WBC)
This is one of the best LR-PRP kits we have tested in terms of platelet recovery % and concentration, consistency of output, and leukocyte concentration.
Another bit of info we would could add in would be the Cost/Billion platelets. For example....if this kit costs $1000 for the 8 Billion platelet dose the metric is $125/Billion platelets. BUT if this kit costs $200 for this 8 Billion platelet dose, then the metric is $25/Billion platelets. This is a nice summary of kit efficiency and true cost to the clinician. It isn't perfect as it does not capture the consistency (ie. 6 cc PRP every time from 60cc blood input) or the spin time or the ease of use OR the quality of the coffee brought in by the company rep!

What is the price range for or in the USA? All PRP is not the same so make sure that you are comparing apples to apples. We can help you with a proper comparison which includes knowing the dose of the PRP and how many injections you will need....at Texas Orthobiologics most of the time it is just 1 injection because we use high dose PRP.

How much should Platelet Rich Pasma (PRP) Cost? Texasorthobiologics.com America's #1 Regenerative Medicine and Orthopedic Surgery ClinicTiffany Franks, PA-C discusses the price range for PRP in the USA. A...

Don Buford, MD has been a staple at OSET for years and years, sharing his wisdom with the next generation of orthopaedic practitioners so they can better improve patient outcomes.

Join Dr. Buford for our new Musculoskeletal Ultrasound Course Friday-Sunday, September 13-15, 2024 only at . Register today at orthosummit.com/2024-registration!

* for Partial Ulnar Collateral Ligament Tears*
This is a diagnosis that has risen in frequency in a younger and younger population. Single sport specialization at a young age carries some potentially damaging consequences..... Anyone with a symptomatic partial thickness UCL tear absolutely needs to have 1 or 2 high dose PRP injections before ever considering surgery. There is no downside and a very very high percentage will heal (ie. 85-90% in 3 months) as good or better than surgery in my experience. In this just published systematic review....even including some studies where the PRP wasn't fully defined or could have been higher dose...the evidence that PRP was an excellent treatment option for this dx is undeniable.

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NEXT WEEK: Join us as Rowan Paul, MD discusses orthobiologics for ligament laxity and joint instability during our last IOF NOW! Webinar of the year. Don't miss this one: https://bit.ly/47U3gE1

*Results from a Handcrafted Protocol*
Recently we had a chance to test a PRP protocol used overseas by colleagues without ready access to PRP kits. They have to make PRP with a centrifuge and test tubes and syringes and needles that they source and put together separately.
The stats:
108 cc blood draw with 12cc of ACD-A (two 60cc syringes with 6cc ACD-A in each) and ultimately 8 cc of PRP was made.
The 120cc was divided into 4 centrifuge test tubes....30cc in each.
First spin was 2.5 minutes.
Decanted the yellow (plasma+platelets) from each of the four test tubes and left the red (RBCs)
Second spin (just two test tubes of Plasma) was 5 minutes.
At the end of the second spin the platelets are at the bottom of the test tube and we removed plasma from each to leave 4cc of plasma in each test tube (8cc total). We then resuspended the platelets in each test tube using the plasma and gentle "swirling".
We combined the PRP to end up with 8cc and below are the results.
Concentration: 8.69x (1747 PRP versus 201 Blood)
Platelet recovery %: 58% (14.0 Billion PRP /24.1 Billion Blood)
Platelet dose for 8cc: 14.0 Billion platelets
(remember we started with a 120cc Blood draw ...not a 60cc!)
Seems like another way to get a reasonable PRP result in parts of the world where kits are not readily available for whatever reason!

*The Cervos Key Bench Test*
Having an in house hematology analyzer means we test every single patient's blood and PRP and record the results in a registry. Very few clinicians can compare real world PRP results from different companies....we love the science!
Last week we got a chance to test the Key PRP system from Cervos Medical.
We used two of the Cervos 40ml kits so that we could process 60ml of Blood to match what we have done with other kits.
The instructions stipulate using the Eppendorf model 5702a which happens to be the same swinging bucket centrifuge that Emcyte uses so we had one on site already.
The kit includes ACD-A. We used a total of 6cc of ACD-A which meant we had 64cc of blood....matching what we did with other PRP protocols for consistency.
The first spin was at 3800 for 2 minutes.
We the used their unique plastic threaded rod to gently extract the plasma/platelet portion, leaving behind the RBCs.
We then added another 2cc of ACD-A to another canister, added the plasma and spun a second time at 3800 rpm for 6 minutes.
After the second spin we recovered 5cc of PRP.
The initial platelet count was 316 (60cc blood)
The PRP platelet count was 1617 (5cc PRP)
Concentration was 5.12X.
Platelet dose was 8.09 Billion platelets (1617 Plt x 5cc)
Platelet recovery % was 43%
You can see the other numbers below....essentially leukocyte neutral, no RBCs, good decrease in granulocytes.