Regenexx Publishes World’s Largest Stem Cell Safety Paper!

stem cell safety research

We’ve published a lot of research and continue to add to those papers. As of this morning, if you add up the number of patients who have had their results published in the U.S. National Library of Medicine after some sort of bone marrow stem cell procedure for an orthopedic injury, the total is 8,549. With the publication of the world’s largest stem cell safety study by Regenexx in the Journal of International Orthopedics this week, 50% of those patients are ours.

What Did Regenexx Just Publish?

Stem cell safety is paramount in the minds of all physicians who use stem cells to treat orthopedic problems. To date, while we have several large safety studies that look at adverse events (side effects) of stem cells (two of those are our prior 2010 and 2011 studies), we have none that compare the safety of various techniques (i.e., same-day versus cultured cells). In addition, we have few large studies that look at all complications, with the biggest orthopedic same-day stem cell paper to date being focused only on whether there’s an increased risk of cancer (i.e., a kidney problem wouldn’t have shown up in this study).

Regenexx just published the world’s largest (2,372 patients) stem cell safety paper in any medical indication (not just orthopedics). This is the most in-depth analysis of safety available. In addition, it’s the longest follow-up period for a large group of patients where all complaints are reported. Finally, the data was collected at multiple treatment sites, and all complications that were considered significant were reviewed by a panel of five physicians and scientists who were not in any way affiliated with Regenexx (independent adjudication of SAEs).

What Do Other Doctors Have on Their Websites?

If you look around the Internet, it seems that every doctor who just took a weekend course on how to inject stem cells has research listed on his or her website. However, what you’ll quickly discover is that much of that research has little to do with the stem cell technique the doctor uses, and even less of it was published by that doctor on the technique being used. In essence, much of it is a bait and switch. Not at Regenexx; we’re the only group of clinics where you’ll find an extensive list of research publications, all of which pertain to the stem cell techniques we use and all of it published by us. So while other sites might provide a false sense of security, our research is published on what we actually do.

How Big a Footprint Does Regenexx Have in Orthopedic Stem Cell Research?

As of this morning, if we add up all of the patients who have had their results published after receiving bone marrow stem cells for orthopedic conditions, 50% of all published research listed in the U.S. National Library of Medicine has been published by Regenexx. That’s pretty impressive when you think about it, and it shows unparalleled dedication to moving this field forward and transparency.

Why don’t you see every stem cell clinic or group out there publishing? Research is expensive and time consuming, so it takes a large chunk out of the bottom line. It requires an expensive patient-tracking registry that employs many full-time people. It requires statistical experts, clinical research coordinators, and expert physicians to write the paper. After hundreds of man hours of work to shape a paper into something that can be submitted, peer review then adds many more hours of revisions and communication with editors.

The upshot! We’re proud to have this paper published. It’s a testament to our commitment to safety and our focus on moving the field forward. That’s why at Regenexx, the stem cell procedure you get is more advanced than anything else available!

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*DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.
Read 6 Comments
  1. Dear Dr. Centeno, Congrats on the publication – wow, what a mammoth effort! And although not a controlled clinical trial, it will serve as evidence for safety in a far more diverse patient population and complement the trials now ongoing – in other words, both are needed. Will there be a similar paper reporting efficacy for the same patients?

  2. Dear Dr. Centeno,
    Very interesting paper,
    There is an ongoing discussion about this paper on ipscell.com

    http://www.ipscell.com/2016/03/stem-cell-clinic-nervana-new-ad-claims-no-side-effects-fda-ok/#comments

    One commentator criticizes that in your study a control group is missing, and thus your study has only a low significance. Also, it is criticized in one comment that your study offers no insights into the effectiveness of the treatment.
    I am only a potential patient and so I can not assess whether this criticism is justified or not? Therefore I would like to ask you to give us your opinion to these comments.
    Thank you very much.

  3. I’ll skip the analysis paralysis in the comments of that post. This study has no control group like a randomized controlled trial. Having said that, those studies are much smaller (typically several hundred patients and not several thousand). So large scale safety is usually established in “post marketing surveillance”. This is why you see drugs that are thought to be safe in FDA trials who later are found to be unsafe once thousands of patients are analyzed. This study is stronger evidence than post marketing surveillance, as that’s based on doctors and hospitals voluntarily reporting side effects, where this study constantly pinged patients about side effects (so it’s more likely to show what was going on).

  4. Dear Dr. Centeno – thanks for your reply to Mike above – very interesting perspective. With your data can we now say that MSC are completely safe for use in humans? Or what statement can we now give that we couldn’t before this work?

  5. Anne, this study along with one published by Hernigou (see http://www.ncbi.nlm.nih.gov/pubmed/24352775) in 1,873 patients, certainly adds to the data that a same day bone marrow stem cell procedure (aka bone marrow concentrate or BMC) is safe for orthopedic applications. I think for most physicians I’ve spoken to, there is little concern about the safety of BMC when injected into a knee or hip (i.e. orthopedic applications).

    For autologous culture expanded bone marrow MSCs for use in orthopedic applications, given this long term safety data and the numerous clinical trials/published studies that have identified no safety issues (i.e no neoplasm), again on balance that’s what the data says right now. This is our third safety paper on that same group. Back when the n was 339 a third party requested and looked at our safety data and also concluded that the procedure was safe (see http://www.ncbi.nlm.nih.gov/pubmed/?term=Safety+of+intra-articular+cell-therapy+with+culture-expanded+stem+cells+in+humans%3A+a+systematic+literature+review#). That n is now more than 700 with another 4 years.

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