My Stem Cell Predictions for 2016

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stem cell predictions

Where will the field of stem cells head in 2016? This year marks the 11th year since we first began using stem cells to treat orthopedic injuries. In that time, I’ve seen this area evolve from a single medical provider specializing  in the use of stem cells to treat orthopedic injuries (us), to an explosion of largely undertrained physicians performing stem cell and other regenerative procedures. During that time I’ve made a few predictions. Many were right and some missed the mark. So here goes for 2016!

  1. The first mass produced stem cell drug in the US will finally get approval from the FDA after almost two decades in the making. This has been a truly long haul for the first mesenchymal stem cell drug, which is almost 20 years in the making due to the nutty regulatory burden. Our friends in Japan already have access to this stem cell drug due to a more reasonable regulatory system. Rather than using the patient’s own stem cells, which is not in keeping with a scalable mass market pharma product that can be inserted into existing distribution models, big pharma has decided that it’s better to mass produce stem cells in a huge bio reactor or sell vials. While many clinics are erroneously advertising that they use “amniotic stem cells”, which sounds like a similar thing, these clinics are in fact injecting dead tissue. This drug will include actual live stem cells. The disease focus for this first stem cell drug will be graft versus host disease, an awful problem whereby a patient rejects an organ transplant and gets very sick. As I’ve discussed before, due to the fact that this mass manufacturing hurts the quality of the cells and that someone else’s cell do activate a part of the immune system in the host, I don’t expect these first generation products to be very financially successful. But heck, it’s a start!
  2. The largest patient safety publication on autologous mesenchymal stem cells will get published. Our 9 year follow-up on 2,365 patients was recently accepted for publication with minor revisions. This will mark the largest clinical experience of patients carefully tracked in a registry for complications ever reported in the peer reviewed literature. It will cover three different stem cell procedure types (two same day isolation and one culture expanded). Along with an excellent paper published last year by Phillipe Hernigou, it will mean that safety for the use of a patient’s own stem cells to treat orthopedic injuries will be well established on more than 4,000 patients!
  3. The explosion of poorly trained physicians offering stem cells will continue…Ughhh! This part saddens me. We’ve seen such nutty things this past year with doctors who were never trained how to properly draw bone marrow, others who are exposing cells to toxic drugs without knowing the difference, and still others claiming that the dead amniotic tissue they’re injecting has millions of live stem cells. Regrettably, I think we’ve only seen the tip of the proverbial iceberg. Based on reports that we have been receiving of complications from IV fat stem cell infusions showing up in Emergency Rooms, this will likely be the year that one of these clinics has a serious complication. This will happen because of the phenomenon of cell clumping leading to a near fatal or fatal embolus. In addition, we’ll continue to see “amniotic stem cell” clinics who are injecting dead tissue into patients and claiming that it is live fetal stem cells. The Interventional Orthopedics Foundation will step up to help begin to educate physicians on the correct way to take and place stem cells and hopefully push manufacturers of amniotic tissue to declare publicly that their products contain no live stem cells. We’ll also likely see a number of medical board actions this year. The Florida medical board has already told it’s physicians that clinics offering fat stem cells as part of a faux clinical study to treat multiple incurable diseases are on their radar.

The upshot? 2016 will be an interesting year. Hopefully better publications and physician education will be the norm. However, I fear more stem cell clinic schlock will ensue!

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17 thoughts on “My Stem Cell Predictions for 2016

  1. An Astute Observer

    4. Paul K will continue accomplishing nothing

    1. Regenexx Team Post author

      Am astute observer,
      Academic researchers and Physician innovator researchers are two entirely different things. Though our labs are very similar except for our additional very specialized equipment, we do research to continually improve and tweak what we can offer patients. We are currently working on a study to determine why some people respond to regenerative therapy better than others and what we can do to further correct for that.

  2. YucatanDan

    Regenexx, is the best in North America. Dr. John Schultz is outstanding, progressive, professional with extraordinary experience. Regenexx is the clear leader in orthobiologicals. Besides being creators and providing superior orthobiologicals the pricing is very reasonable.

    I believe ” Facia” or, Myofacial system” is one issue not many are addressing. In my personal experience has been to receive myofascial release, structural integration, Rolfing to release adhesions, restrictions, scar tissue that any be inhibiting the flow,spread after injections. After, SCP and BMAC injections my ” fascia” became much more fluid and allowed well trained, experienced manual therapist to greatly improve my range of motion. The therapists definitely noted and commented that tree was clear differences as he worked on me pre and post injections.

    The Fascia Conference has been held in Boston At Harvard for five years. I think this is one possibility That may improve results for patients receiving SCP, BMAC. Dr. Robert Schleip, Germany is the leading researcher , scientist on Fascia. There is some interesting findings about anti inflammatory Cytokines being released when fascia is held Ina stretch for a minimum of 120 seconds. At 3-5 minutes cytokines begin to release.

    Dr. Centeno, Dr. Schultz have pioneered their procedures longer than the majority and, should be commended for their dedication to Regnexx to,provide a safe alternative to many prescription medications and surgeries which often may do more harm to a patent.

    Happy New Year!

    1. Regenexx Team Post author

      YucatanDan,
      Thank you, much appreciated. Fascia work can be very beneficial. Both Rolfing and Egoscue have helped many.

  3. Jan Tucci

    I had the pleasure of being treated by Regenexx Dr. Fenton in Vermont this past summer. I am still pain free and able to pursue yoga, pickleball, and water aerobics . My hope is that the procedure be approved by insurance companies

    1. Regenexx Team Post author

      Jan,
      Wonderful to hear! I think it accurate to say we’re all on the same page there…

  4. Anne Smith

    Will Regenerexx’s own products be subject to controlled clinical trials?

    1. Regenexx Team Post author

      Anne Smith,
      Yes, we currently have 3, two of which are still enrolling: https://regenexx.com/blog/blog-on-new-study-listings-in-clinicaltrials-gov/ https://regenexx.com/results/research/

  5. Anne Smith

    Dear Regenexx Team, Thanks for the clinical trial links. The descriptions say Regenexx-SD (bone marrow aspirate concentrate) will be injected, but do you know approx. how many cells this will be? Will the cells be a mixed population of all cell types taken from the bone marrow?

    1. Regenexx Team Post author

      Anne,
      Cell numbers vary widely from individual to individual, so there is no way to know for any one person. Suffice it to say that recovery of stem cells per cee will be substantially higher than clinics that use a bedside centrifuge. Yes, Regenexx SD is a mixed population.

  6. Anne Smith

    But won’t you profile each “dose” so that you know how much you’re injecting and what proportion are stem cells?
    Also, it seems the trial will be done only in Regenxx clinics and not in independent clinics so will you follow-up with multicentric studies and then an NDA?

    1. Regenexx Team Post author

      There is no need to profile each dose beyond a total nucleated cell count, see http://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-015-0714-z . The TNC count follows the MSC count closely and this method can be used by most providers at the bedside to adjust dose, which is something that flow cytometry or CFU counts can’t do. A same day BMC procedure (Regenexx-SD) was not classified as a drug, so we will do our own studies, which anyone is free to replicate. For our cultured stem cell “drug” that is going through FDA trials and is following the IND/BLA track, that will go through studies at academic medical centers.

  7. Tom

    When and where can I read your 9 year follow up study? And where can I find the paper of Phillipe Hernigou?

    1. Regenexx Team Post author

      Tom,
      Our paper will be available soon, this is the Hernigou paper: http://www.ncbi.nlm.nih.gov/pubmed/25757411:

  8. Tom

    Thanks, please let us know, when we can read it.

    1. Regenexx Team Post author

      Tom,
      Will do.

  9. Larry

    SCOI in Valencia CA 91355 is my doctors offices… Can you tell me if insurance covers any of the procedure for Stem-Cell, I have bone-on-bone both knees inside area. I have been able to stall surgery for 1 1/2 years now. I work out in pool doing jumping jacks and leg kicks. I read that military jumping jacks can increase bone marrow (or tissue), not a doctor so maybe you can clarify?

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