Colorado-based Regenexx has, according to the June 15, 2016 news release, published “the world’s largest stem cell safety paper. The study was published in International Orthopaedics (March 30, 2016). The purpose of the study was to determine if mesenchymal-stem-cell-based therapies [MSC] are safe procedures when used for orthopedic degenerative conditions or injuries, and it included 2, 372 subjects who received a total of 3, 012 stem cell injection procedures.”
Regenexx: New Stem Cell Safety Paper
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“Subjects underwent a precise injection using imaging guidance of an orthopedic condition between December 2005 and September 2014 at one of 18 clinical facilities located in the United States or Australia, and they had attained at least a three-month follow-up period. They were followed in a treatment registry for up to nine years.”
Study author Chris Centeno, M.D., founder of Regenexx, said, “This is the most in-depth analysis of safety available for any indication in stem cells. In addition, it’s the longest follow-up period for a large group of patients where all complaints are reported.”
The company indicates that, “Five independent adjudicators (not in any way affiliated with Regenexx) were used, including a physician from the Mayo Clinic, to independently conclude if any serious adverse events were related to the procedures.”
According to the news release, “The study was broken down into types of stem cell procedures the patients received: 1, 590 patients received bone marrow concentrate (BMC) injections only, 247 patients received BMC injections with adipose (fat) graft, and 699 patients received culture-expanded MSC procedures. The lowest rate of adverse effects (AEs) occurred in patients receiving BMC injections alone. Higher rates of AEs occurred in patients receiving BMC plus adipose and cultured cells; this was readily explained by nature of therapy or longer follow-up.”
The study concluded, “Although efficacy is best demonstrated with randomized controlled clinical trials, it is reasonable to conclude that the results of the present study add to the existing body of evidence showing the safety of MSC based therapies for orthopedic conditions.” Dr. Centeno is quick to add, however, that not all stem cell providers are created equal, and a safe procedure is dependent on a reputable provider using the appropriate techniques.
Dr. Centeno told OTW, “This, the largest safety paper in orthopedic stem cell use, provides additional, important information that both same day and culture expanded bone marrow procedures are safe, especially when using this specific treatment protocol.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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