BMAC vs Adipose for RTC Tears

[drusso]

Which do you use and why?

Arthroscopy. 2019 Dec 2. pii: S0749-8063(19)31160-0. doi: 10.1016/j.arthro.2019.11.120. [Epub ahead of print]
Intratendinous Injection of Mesenchymal Stem Cells for the Treatment of Rotator Cuff Disease: A 2-Year Follow-Up Study.
Jo CH1, Yoon KS2, Chai JW3, Jeong EC4, Oh S5.
Author information
1Department of Orthopedic Surgery, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea; Department of Translational Medicine, Seoul National University College of Medicine, Seoul, Korea. Electronic address: [email protected].2Department of Orthopedic Surgery, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea.3Department of Radiology, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea.4Department of Plastic Surgery, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea.5Department of Biostatistics, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea.
Abstract
PURPOSE:
To assess the mid-term safety and efficacy of an intratendinous injection of autologous adipose tissue derived MSCs (AD MSCs) for rotator cuff disease at 2-year follow-up.
METHODS:
The first part of the study consists of 3 dose-escalation groups; the low- (1.0x107 cells), mid- 5.0x107), and high-dose (1.0x108) groups with 3 patients each for the evaluation of the safety. The second part was planned to include nine patients receiving the high-dose for the evaluation of the exploratory efficacy. Clinical outcomes were assessed according to pain, range of motion, muscle strength, functional scores, overall satisfaction and function, and the presence of failure. Structural outcome included changes of volume of tendon defects measured using MRI.
RESULTS:
Nineteen patients (9 for the first study, and 10 for the second) with a partial-thickness rotator cuff tear were enrolled. There were no treatment-related adverse events at minimum 2-year follow-up. Intratendinous injection of AD MSCs reduced shoulder pain by approximately 90% at 1 and 2 years in the mid- and high-dose groups. The strengths of the supraspinatus, infraspinatus, and teres minor significantly increased greater than 50% at 2 years in the high dose group. Shoulder function measured with the six commonly used scores improved for up to 2 years in all dose groups. The structural outcomes evaluated with MRI showed volume of the bursal-side defect in the high-dose group nearly disappeared from 1 year, and did not recur up to 2 years. There were no failures defined as occurrence of any kind of shoulder surgery or the return of the SPADI score back to preinjection level during the follow-up.
CONCLUSIONS:
This study demonstrated continued safety and efficacy of intratendinous injection of AD MSCs of for the treatment of a partial-thickness rotator cuff tear over 2 years through regeneration of tendon defect.

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[lobelsteve]

So how does it play out with just time and PT?

 

[willabeast]

Did everyone do the same PT program? Reason i ask is that is how one boosts one's results - different groups get different PT. BTW this happens a lot in all sorts of situations in the real world. Sometimes the only way to get competent PT is if you see a surgeon.

 

[Ferrismonk]

You forgot to add PRP to your questionnaire.

 

[drusso]

You forgot to add PRP to your questionnaire.

Great point. What’s your threshold for bumping up from PRP or a cytokine based treatment to a cellular one?

 

[Ferrismonk]

Great point. What’s your threshold for bumping up from PRP or a cytokine based treatment to a cellular one?

Honestly, if money weren't an issue, I'd use BMAC for every tendon tear. If there is a defect, arguably the cellular therapy is better. If its simply tendinosis though, I'd argue PRP is good enough.

 

[Ducttape]

critiques:
1. very small group of patients.
2. as lobel mentions, no control of standard therapy and no control of placebo based procedure.
3. encouraging results, but....

 

[drusso]

critiques:
1. very small group of patients.
2. as lobel mentions, no control of standard therapy and no control of placebo based procedure.
3. encouraging results, but....

You need boots on the ground experience (content knowledge) before a critique can be credible. Things that I know that work and don’t I know from direct experience not by watching the parade.

If you know that high opioids work or don’t work in a patient you know that from experience. Ditto for cellular therapy.

 

[lobelsteve]

You need boots on the ground experience (content knowledge) before a critique can be credible. Things that I know that work and don’t I know from direct experience not by watching the parade.

If you know that high opioids work or don’t work in a patient you know that from experience. Ditto for cellular therapy.

If it quacks like a duck, injects like a quack, feed it mu-shu.

 

[Doctodd]

all of the above......but id like to see the re-tear rate from corticosteroids vs others.

 

[Ducttape]

You need boots on the ground experience (content knowledge) before a critique can be credible. Things that I know that work and don’t I know from direct experience not by watching the parade.

If you know that high opioids work or don’t work in a patient you know that from experience. Ditto for cellular therapy.

I need science and data to justify experimenting on patients.

this study doesn't have enough patients to use it as a basis to recommend using it as a treatment, but adds a piece to the whole.


that being said, if my patients had appropriate clinical and financial situation, this study edges me ever so slightly to the point of referring to someone who does these injections.

 

[drusso]

I need science and data to justify experimenting on patients.

this study doesn't have enough patients to use it as a basis to recommend using it as a treatment, but adds a piece to the whole.


that being said, if my patients had appropriate clinical and financial situation, this study edges me ever so slightly to the point of referring to someone who does these injections.

You don’t know the difference between experimenting and innovating do you?

 

[lobelsteve]

Helsinki does.

 

[drusso]

Helsinki does.

Elaborate.

 

[lobelsteve]

Declaration of Helsinki, 2008: implications for stakeholders in research - PubMed

The Declaration of Helsinki (DoH) was adopted by the World Medical Association (WMA) in 1964, as a statement of ethical principles, to provide guidance to physicians and other participants in medical research involving human subjects. Having undergone several amendments, the most recent version...

www.ncbi.nlm.nih.gov

 

[drusso]

Declaration of Helsinki, 2008: implications for stakeholders in research - PubMed

The Declaration of Helsinki (DoH) was adopted by the World Medical Association (WMA) in 1964, as a statement of ethical principles, to provide guidance to physicians and other participants in medical research involving human subjects. Having undergone several amendments, the most recent version...

www.ncbi.nlm.nih.gov

Here’s the authoritative reference for orthobiologics...

Orthobiologic Ethics

orthobioethics.com

 

[lobelsteve]

The Orthobiologic Ethics Statement – Orthobiologic Ethics

orthobioethics.com

Weak sauce. Look who is running the show at this place. Pioneers in the field. Of making a business out of $tem$ells.

 

[Ducttape]

You don’t know the difference between experimenting and innovating do you?

clearly, innovating is not experimenting. snake oil is experimenting.

Our group includes physicians, surgeons, chiropractors, scientists, nurses, nurse practitioners, physician assistants, orthopedic physician assistants, salespeople, vendors and anyone interested in orthobiologics.

the inclusion of these individuals doesn't bias the group???