A Patient from Our Rotator Cuff Stem Cell Injection RCT

By Chris Centeno, MD /

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rotator cuff stem cell injection rct

We’ve been slowly recruiting for a randomized controlled trial for the last few years that compares rotator cuff tears treated with a precise injection of high-dose bone marrow concentrate (HD-BMC) with physical therapy. This morning I’d like to update everyone on where the Rotator Cuff Stem Cell Injection RCT study stands and show a before and after MRI image (above). I’d also like to predict the future of traditional surgery by looking back into our past.

Treating Rotator Cuff Tears with Stem Cells

We published on a case series of more than 100 shoulder patients treated with precise high-dose BMC back in 2015. The results were excellent, and as of this morning, looking at our live registry-based outcome data, we’re tracking just under a thousand treated shoulder patients (n=968). In addition, the results are still excellent. Below I’ve shown the SANE scores (percentage reported improvement) and the functional score we use (DASH). In both of these metrics, more is better on the graph.

An Update on our Rotator Cuff Stem Cell Injection RCT

RCT stands for randomized controlled trial. In this case, we randomized rotator cuff tear patients to either get a precise HD-BMC injection or a physical therapy (PT) routine. We have recruited enough patients to satisfy the control group (PT), so every patient now will get the treatment. Below are some of the results to date comparing the two:

shoulder stem cell injection

The results? They are excellent.

An MRI from That Study

Above is a sample MRI from the RCT, a before and after image that was taken of one of Dr. Markle’s patients. Note the white areas in the white dashed oval. These represent tearing. Also note that in the after image, these have disappeared. They’re now replaced by a dark tendon, which is more consistent with normal tendon. In fact, the reading radiologist read this one out as normal.

An MRI from Ancient History

We pioneered this precise injection-based treatment technique for shoulder rotator cuff tears. Want proof? Below is the first shoulder MRI we reviewed on a patient who we treated with a precise stem cell injection. This was way back in 2007, long before any physicians in the U.S. had even heard of injecting stem cells to treat tendon tears.

The Future?

It’s pretty clear to me based on what I’ve seen over the last 13 years and our published research and Rotator Cuff Stem Cell Injection RCT results that traditional shoulder rotator cuff repair surgery is about to take a serious haircut. That includes a bevy of device manufacturers in this space who make everything from resorbable anchors to arthroscopy equipment. Why? Larger partial-thickness and complete nonretracted tears don’t require surgery. Instead, they can be healed with just a precise high-dose bone marrow concentrate injection. While surgeons dream of getting to perform their surgeries and then throwing magic stem cell pixie dust into the area upon closing, there’s a big problem with that approach. It’s cost plus, meaning the cost of the surgery, plus the cost of anesthesia, plus the cost of a surgery center, plus the cost of equipment and devices, plus the cost of the stem cells. That will never be able to compete financially with an outpatient injection procedure. In addition, the latter has far fewer costs related to complications and side effects.

The upshot? After more than a decade using imaging guidance to precisely inject stem cells into torn rotator cuffs, I’ve learned a thing or two. The biggest lesson this work has taught me is that in the future, rotator cuff surgery rates will fall by at least half. So if you’re a surgeon, begin retraining. The IOF has some great courses in precise ultrasound- and fluoro-guided shoulder injections. Change is good…

Category: Shoulder

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14 thoughts on “A Patient from Our Rotator Cuff Stem Cell Injection RCT

  1. Ann Rice-Johnson

    I have had 2 rotator cuff repairs and am still in pain in spite of doing physical therapy intermittently. Please refer me to an expert for stem cell injections. Ann Rice-JOhnson

    1. Regenexx Team

      Ann,
      We have many. Where are you located?

  2. Matt Hester

    So if rotator cuff surgery will be cut by at least half, the obvious question to the masses is “When will insurance companies start paying for stem cell injections?” Has any progress been made with them by presenting the data fro the study?

    1. Regenexx Team

      Matt,
      It’s a great idea and would help if the issue was proving that these procedures work. These explain the real issues. Please see: https://regenexx.com/blog/does-meniscus-repair-work/ and https://regenexx.com/blog/the-orthopedic-structural-paradigm-is-dead/ and https://regenexx.com/blog/payola-in-medicine/ and https://regenexx.com/blog/modern-orthopedic-surgery-for-pain/ The good news is we’ve made great progress with Companies that self fund their employee’s healthcare, and with Medical Cost-sharing plans. What they have in common is they have a vested interest in both the patient’s health, and in keeping cost down.

  3. Gary Devereux

    I need to find a doctor here in the Eugene Springfield Oregon area that does the stem cell repair of my arthritic shoulder. I have both a x-Ray and MRI. The doctor I am seeing wants to use fat stem cell from my stomach area for the injection. What do you think.
    Gary

    1. Regenexx Team

      Gary,

      We have 3 Regenexx Providers in Oregon: https://regenexx.com/find-a-physician/ For shoulder arthritis, bone marrow stem cells would be the the most effective. Please see: https://regenexx.com/blog/can-treat-severe-shoulder-arthritis-injection/ and https://regenexx.com/blog/severe-shoulder-arthritis-stem-cell-update-im-blown-away/ /A good question to ask is what is the fat procedure called? SVF is illegal in the US. This explains the different types of stem cell procedures being offered today, and how the FDA classiffies them: https://regenexx.com/blog/using-common-orthobiologics-explain-fda-1271-regulations/

  4. Richard Kingham

    This is great news. You are treating both shoulders in July in GC. The RT has been operated on twice and I DO NOT wish to go through another surgery if I don’t have to.

    1. Regenexx Team

      Great news Richard, I look forward to it!

  5. Bart

    Since you brought it up …. financially, I can choose between Medicare shoulder surgery at no cost with an excellent ortho, or PRP & Stem package for about $7,500 here in SoCal. I’d prefer the latter, but my budget disagrees. Can I volunteer as a case study? Have MRI cd in hand ….
    ps … Long time receiving your informative mailing list

    1. Regenexx Team

      Bart,
      Tough choice, as there is a difference in long-term results. But if you do need to go the surgery route, here are some things to read up on and discuss with your Doctor before the surgery: https://regenexx.com/blog/shoulder-surgery-complications-caused-by-acromioplasty/
      https://regenexx.com/blog/shoulder-separation-surgery-recovery/ Here is the information on the Rotator Cuff tear RCT. Like all actual RCT’s there are specific exclusion and inclusion criteria. Please see: https://regenexx.com/stem-cell-research/#studies

  6. Joe LaValle

    I have a “small full thickness” tear of my supraspinatus tendon, per MRI reading, but I still have reasonably good strength and flexibility with only minor discomfort. The PT team I worked with didn’t believe I had a full thickness tear based on the strength I showed in their several tests. However, I have a lot of pain and shoulder discomfort right at the AC joint in the same shoulder. It evens hurts when I press down lightly on the top of my shoulder. I have a mid-June appt w/Dr. Pitts for MSC aspirate at your Cayman facility, and an August appt w/Dr. Markle for re-injection for a knee problem. Will a stem cell injection directly into the AC joint help w/my shoulder AC joint issue?

    1. Regenexx Team

      Joe,

      Dr. Markle would be able to determine exactly what would need to be injected for pain in that area in your particular case. It’s often not the obvious. Please see: https://regenexx.com/blog/watch-advanced-image-guided-injection-shoulder-step-procedure-suite-dr-schultz/

  7. Rick Gorzen

    I have 2 torn rotator cuff and live in Michigan. Do you have affiliates in Michigan?

    1. Regenexx Team

      Hi Rick,
      No, but we have several approximately equidistant in the surrounding area. Please either submit the Candidate form here: https://regenexx.com/conditions-treated/shoulder/, or give us a call at 855 622 7838 so we can help find the best location for you.

Chris Centeno, MD

Regenexx Founder

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications.
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