Dallas PRP and Stem Cell Institute

*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, PRP injections, and surgical options? We have a webinar for you next Thursday at 5p PST, 7p CST, 8p EST
Patient videos, actual ultrasound guided procedure videos, surgery videos, patient results, literature review....
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

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!

*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

* 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!

Looking for an online webinar for PRP analysis and evidence based PRP dosing protocols?

Free Registration: https://us06web.zoom.us/webinar/register/WN_YfqoLWi9TQaFbG-b5IPjkw

Biologics Association Sponsored PRP Webinar
Thursday, February 29th
7:30p EST; 4:30p PST
1 hour
Speakers:
Don Buford, MD of Texas Orthobiologics

Jo-An Tremblay
plymouthmedical.com

Topics:
How to use a hematology analyzer...best practices for accurate results.
How to use a registry for patient reported outcome measures and orthobiologics data.
How to evaluate PRP and calculate dosing and other parameters.
How to translate current orthobiologics literature into clinical practice guidelines.
AMA (ask me anything) time with the speakers in open forum discussion on current practice tips and pearls!

Welcome! You are invited to join a webinar: PLYMOUTH MEDICAL PRP Characterization and Dosing Webinar. After registering, you will receive a confirmation email about joining the webinar. Come learn everything you need to know about PRP cell counting from industry experts at this fast-paced 60min live webinar. Our trailblazing team will instruct attendees on how to transform hematology data into tangible clinical insights at the point of care (POC). Objectives: 1) Review what data to...

Looking forward to AAOS' Annual meeting in San Francisco next week. Give a shout if you will be around!
Tuesday AAOS-BA Symposium
Optimizing the Care of your Patients using Biologics
3:10 PM - 3:20 PM - When is it best to use BMAC D. Buford

Wednesday ICL 383 11:00a - 12:30p
Case-Based, Advanced Decision Making in Complex Shoulder Instability: Anterior, Posterior, Bone Loss, and Revisions (ICL)

My Topic: Failed Bankart with 15% glenoid bone loss and non Engaging Hill Sachs --- what to do?

How do we measure the dose of platelet rich plasma?
Dose = volume of injected times the platelet concentration
We helped a patient today who has knee arthritis and pain. We drew 216cc of blood and the platelet count was 242....making the
starting total number of platelets 52 Billion. After centrifuging and concentrating the platelets we ended up with 12 cc of PRP and the platelet count was 2357! Total ending platelets was 28 Billion. So our protocol concentrated the platelets by a factor of 9.7X. The platelet recovery percentage, a measure of the efficiency of the protocol to make the PRP, was 54% which is reasonable. This is the type of data a clinic serious about regenerative medicine and serious about clinical research should be able to provide every patient in our opinion! All of this information is stored in an online registry so we can refine what works best!

This is what it looks like when you have to demo on the latest technology that may be useful in MSK ultrasound and !!!
At the 2024 Vegas Regenerative Medicine and MSK Ultrasound Course (www.orthosono.com) I talked about using Xreal Air smartglasses as a virtual display while doing ultrasound guided regenerative medicine procedures like and injections.

What could happen if you advertise stem cell therapies in the USA? Well, the State Medical Board Could restrict your license for starters!!!!

We are seeing this nearly every month in Texas. This physician is getting penalized for the infractions listed below including advertising stem cell therapies, not doing an informed consent, and not doing an adequate H&P.
Do these penalties seem enough to discourage this behavior?

10 more days to save $300 on your IOF MAX Experience registration! ATTEND: bit.ly/IOF2024

Last year, IOF became the largest orthobiologics conference in the U.S. You know you're going to have FOMO if you don't attend this year, so make sure you save a little bit of money on the registriation fee!

www.orthobiotexas.com
Texas Orthobiologics is growing up!
Some of our new top secret equipment is packed up and on the way to the USA for our new facilities opening this year. Our and (bone marrow concentrate) options are just some of the ways we help people with joint pain, back pain, and sports injuries.
People like going to one place and getting all of their regenerative medicine and orthopedic surgery options in an evidence based, unbiased consultation with a board certified orthopedic surgeon!

Next location opening: Frisco, Texas
Opening September 1, 2023
We do telemedicine for Texas, Nevada, Arizona, Colorado, and Oklahoma too! Call us at 877-777-8883.

https://www.sciencedirect.com/science/article/abs/pii/S088354031630153X
In this 2016 randomized clinical study...Toradol works just as well as steroid.....so time to retire steroid for intra-articular injections.

Steroids do one thing really well.......they are anti-inflammatory. Virtually every other effect of a steroid injection is not awesome and some are harmful. Patients can have soft tissue atrophy, skin coloration changes, cartilage toxicity, and the big one.....increased risk of infection if surgeries or procedures are done after as few as 1 steroid shot!

There are other safe options to help people with joint pain where a direct injection is indicated.

At Texas Orthobiologics we do a lot of Regenerative Medicine injections for patients with chronic joint pain and activity related pain.

One non-Regenerative medicine option is an intra-articular injection of Toradol. Toradol is a well-studied NSAID most commonly used for pain control. Results of Toradol injections have been compared to results of a steroid injections for patients with knee arthritis. Toradol does not have the potential side effects of a steroid injection and the cost of the medication is under $3 per injection currently.

For patients that want longer term pain relief, and a chance to have additional beneficial effects from an injection....we have our Regenerative Medicine options.

Can cartilage regrow from an injection into an arthritic knee? | Texas Orthobiologics Can cartilage regrow from an injection into an arthritic knee? | Texas Orthobiologics

Platelet Rich Plasma (PRP) for Bone on Bone Knee Arthritis? Yes, Please...... | Texas Orthobiologics Platelet Rich Plasma (PRP) for Bone on Bone Knee Arthritis? Yes, Please...... | Texas Orthobiologics

Video of Stem Cell Injection Alarms Doctors In the video, a wrestler receives an injection in his carotid artery at a clinic in Mexico

TOMORROW! Our first Women in Orthobiologics virtual get-together is taking place at 5 p.m. PT.

This group is dedicated to building a trusted community that women physicians in the orthobiolgoics field can to turn to for support in business, medicine and life.

Attend tomorrow's meeting ⬇️

Zoom Meeting ID: 297 123 0299