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!
- 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!
- 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!
- 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!