A Regenexx Stem Cell Research Contest…Be Part of the Process of Discovery
As I’ve often blogged, Regenexx is different. From a 30,000 foot view, the rapid adoption of stem cells to treat a variety of problems is still in what I call the “Fantasy Stage”, while Regenexx has long since moved into what I call the “Transnational Stage”. Stat Sat, short for Statistics Saturday, is my way of engaging my readers in that more advanced discussion. Let me explain.
Every new medical technology goes through three predictable stages: fantasy, translational, and acceptance. The fantasy stage is a wonderful place to be, a bit like childhood. Everything seems possible. It’s also wonderful for patients, as everyone believes that a magical therapy will be able to solve their issue. The translational stage is a bit more like adolescence. It’s a bit awkward as you keep some of the fantastical thinking that defined childhood, but you try to mold that into what will work as an adult. You begin to get serious for the first time as you have some responsibilities. The acceptance phase is when a technology reaches adulthood. It’s refined and we know exactly where it works and where it fails.
The fantasy stage in the adoption of a new medical technology is when most physicians have no idea of the full uses, boundaries, and limits of a new technology. They have limited direct experience and in fact most of their experience comes from hearing a lecture from an evangelist physician painting that technology in the best possible light. This is like the “honeymoon phase” or as I described above, childhood. During this time, there’s lots of magical thinking by providers and this rubs off on patients. This happens with all medical technologies, be it stem cells, a new drug, or a new procedure. In my 25 or so years in medical practice I’ve seen it many times. One of my recent non-stem cell favorites was “methylene blue”. A small study was published in China showing that patients who had painful degenerative disc disease who had their discs injected with this common and very safe medical dye got fantastic and prolonged relief. In fact, almost everybody in the study who got injected had relief. As a result, many of the more forward thinking physicians routinely injecting discs began trying this simple injection and regrettably, it didn’t work as advertised. Now this is not to say that stem cells don’t work, as IMHO, when used properly, stem cells have already passed this “generalizability” test. However, how well they work and in what type of patients is a conversation that’s missing right now. The technology is simply too new to most doctors who just learned how to do this in a weekend course somewhere.
After the fantasy stage comes the “Translational Stage”. This means that data is collected on many many patients and that information is collected to see who did well and who failed the treatment. Gone is the fantasy that the therapy works in everyone (no medical therapy, including antibiotics works in everyone). So the focus shifts from “this is the best thing since sliced bread”, to “how do you make the best toast”, i.e. how can we ensure that we know how best to apply and refine the technology. This is where we at Regenexx find ourselves, using data to refine what we know. Some patients have recently been concerned that I don’t spend as much time blogging about individual patient success stories. While the stories are still coming fast and furious and sometimes I feature them, I also have a bigger responsibility to patients and colleagues alike to move Regenexx through this translational stage into the acceptance stage. In that last stage, because of the data collection and technology refinement that occurred in the translational stage, the therapy becomes accepted by a majority of the medical community. In addition, the technology is improved as much as it can be and physicians can reliably tell patients with problem A, who also have problems B and C, the likelihood that the therapy will work.
The translational phase is a lot of fun and defines what medical discovery is all about. While the pharma pathway for a new drug often skips many important parts of the translational stage by taking something that seems to work in animals and pulling the trigger on clinical trials in humans, physicians develop technologies differently. The advantage of physician discovery lies in the fact that what emerges into clinical trials is a fully formed technology that has been the developed into the best it can be. This is why more technology developed by physicians moves into the acceptance phase than technology developed by drug companies (i.e. most candidate drugs fail clinical trials). There’s a great article on the problems with the pharma clinical trials process by Clifton Leaf writing in the NY Times. In summary, the strict criteria in these trials creates an artificial world where drugs are tested. In contrast, the physician discovery process uses registry data (like the one we run) to advance the technology. It is the yin to this clinical trials yang that starts and ends with treating real patients with real world problems.
So Stat Sat will allow you to participate in that translational phase. Every Saturday I’ll post a stem cell research question that we’ve recently tackled here. It could be either a question that I asked our bio stats and clinical registry team or one that I asked our lab research team. To keep it interesting, you can try to guess the answer by responding on our Facebook post or by tweeting to #Statsat. The closest guess to the answer will win something.
So for this inaugural Stat Sat, here’s the research question: When we first began to research how to get more stem cells from bone marrow (which gave rise to SD-plus), we ran an experiment with the radically different bone marrow isolation method. It showed significantly more stem cells using four color flow cytometry in our lab (a machine that uses four different lasers to light up surface markers on stem cells). While I’ve stated conservatively that the new SD-plus procedure gives 5-7 times more stem cells, the counts can be much higher and they were on that day. For that experiment, on a percentage basis, how much higher were they? You have through this weekend to answer as above (on Facebook and Twitter) and I’ll announce the winner of a $500 gift certificate towards the price of a Regenexx-SD procedure on Monday morning (transferable). One guess per person!
The upshot? We’re beyond the fantasy stage, now investing resources into figuring out the best ways to refine and improve our procedures. Nobody else is at that stage, but we’ll have company soon enough. We’ve also spent the last two years looking who are the best and worst candidates and will likely spend two more years building on that knowledge. We’d like to engage you in this exciting phase of discovery!