It's 2019 and I'd like to wish everyone a Happy New Year! What does the future hold? What will be new, and what will stay the same? Those are just a few of the questions I hope to answer this morning.
As far as predictions for regenerative medicine, I've been both accurate and totally incorrect. For example, I was spot on in seeing that the chiro stem cell clinic phenomenon would explode, but missed the boat completely in predicting that this would happen in the first place. Since 2019 should be very interesting for regenerative medicine, I'd like to give my predictions for this space. Here goes!
1. FDA will continue to crack down on bad-actor clinics. The FDA was active last month in using Liveyon as an example of what it considers problem behavior in the stem cell wild west. It also acted in May to begin the process of shutting down US Stem Cell and Cell Surgical Network, who are using fat stem cells to treat multiple incurable diseases. I suspect that we will see more amniotic and umbilical cord manufacturers get letters from the FDA. The regulatory violations are just too common and too egregious for me to believe otherwise. I suspect we'll see other players get letters as well and some court action on US Stem Cell and Cell Surgical Network.
2. The out-of-control alternative-medicine expansion into investigational care will continue. At the end of the day, using stem cells to treat orthopedic problems with bone marrow concentrate is becoming less investigational every day, but using birth tissues, bone marrow aspirate, or fat is still highly investigational. One of the things that's very concerning is that while physicians possess the abilities and are licensed to deliver investigational care, like stem cell therapy, midlevels, like physician assistants and nurse practitioners, are not. Nor are chiropractors, naturopaths, or acupuncturists. This is a real public health risk that will expand. So we will likely see a doubling of the number of alternative-health clinics offering "stem cell" therapy, and most of these will be injecting dead amniotic or umbilical cord products.
3. More patient injuries and worse will continue to be reported. The out-of-control wild west of stem cells, especially with alternative practitioners offering risky IV umbilical cord "stem cell" therapy for everything from antiaging to whatever ails you, will continue to produce complications. Some of these will be severe, likely due to the dead tissue in these products and endotoxins, leading to immune system rejection reactions in patients. As an example, cases of patients ending up in the ICU after an umbilical cord therapy have been widely reported among physicians in this space, but I suspect we will see some make the news.
4. More research will be published on bone marrow concentrate. We use a high-dose form of bone marrow concentrate in our same-day stem cell procedures and have recently published our first RCT. We will likely publish halfway-point papers on our next two RCTs, and I suspect we will see other investigators publish as well. I would bet that by year's end, we'll have three to five new bone marrow RCTs focusing on orthopedic injuries.
5. More fake provider networks will pop up. Right now, near as I can tell, Regenexx has the only provider network that uses strict inclusion and training guidelines plus data collection and publication as well as surveillance of processing sites. However, we have seen all sorts of crazy arrangements call themselves provider networks. My favorite, and one category that is sure to expand in 2019, is the device or tissue sales rep who lists the clients that buy his or her product as a medical-provider network! I guess if you stop buying their stuff, you're no longer on the network? So the number of faux provider networks will continue to expand.
6. We will reach more than 2,000 stem cell clinic sites, and it could be closer to three thousand by year's end. With the crazy addition of alternative medicine and now antiaging practitioners and the never-ending supply of fake stem cell products from birth tissues (amniotic and umbilical cord derived), we will continue to see a rapid expansion in the number of practitioners. Why? Offering stem cell therapy used to require much physician training, but aggressive sales tactics by amniotic and umbilical cord dead-tissue vendors have made the barrier to entry low. It's now as simple as "buy our dead tissue, call it live stem cells, hold a seminar promising magic, collect big bucks from desperate patients, and inject this stuff" to offer treatment.
7. Chiropractic clinic law-enforcement raids and attorney-general crackdowns will ramp up. I know of at least one planned police raid planned for the new year, and I suspect that means there are at least several more that I don't know about. These will be all-out yellow police tape affairs where chiros are arrested for fraud and the birth-tissues products are seized by investigators. This past year we also saw the North Dakota AG's office take down a chiro clinic for fraudulent amniotic "stem cell" offerings. I would expect that this year will feature three of these police raids. I will also predict that we'll see at least two to three more AGs take out local chiro clinics.
8. More FTC actions against chiro and medical clinics. This past year the FTC fined at least one magic amniotic stem cell clinic for fraudulent advertising. I expect more of this to happen as the ads promising magic have become common. I suspect we'll see at least two actions against major chiro-clinic chains. We'll likely also see at least one physician-run "cure all" clinic get busted.
9. More amniotic and umbilical cord commercial product tests by third parties will emerge. This past year we saw Lisa Fortier from Cornell chime in that her tests of 11 amniotic products (many of which where the manufacturer claimed were live stem cell products) demonstrated all dead tissue. This next year we'll see likely one and possibly two more third-party tests confirming that existing amniotic and umbilical cord commercial products are dead tissue.
10. Regenexx will hit 10–20 million covered lives on its self-insured interventional orthopedics coverage program. Right now, we are the only network offering orthobiologics with coverage through fortune 500 companies. That program will continue to expand. I wouldn't be surprised if we hit 20 million people with insurance coverage for Regenexx, but I suspect that 10 million is a safe prediction.
So will I be right? Who knows, but we'll circle back next year to see how many of these predictions came true, how many were near misses, and if any were absolute flops! In the meantime, have a great New Year's Day!