Our Research Biobank: A Regenexx Clinical Research Update
I recently saw a video produced by a cord blood “scam cell” vendor that loves using blondes with big blue eyes in its ads. This was a tour around their lab facilities, which near as I can tell are all fictional. This same fiction continues at any number of fake stem cell “institutes,” which once mapped on Google, show a strip-mall chiropractor’s office. In contrast, at Regenexx, our research team is always working on something. This week I interviewed one of our scientists working on a critical research project to store every single patient’s bone marrow stem cell sample for future research studies.
One of the reasons Regenexx has been successful in this space for almost a decade and a half is that it puts its money where its mouth is. Meaning that while other provider networks are focused on adding any physician with a heartbeat and a medical license or holding “scaminars” to lure unsuspecting patients, we have been focused on the back end lab and clinical research to help guide the decisions of our very selective panel of providers.
One of the unique things about Regenexx is that we have a real university-level cell biology lab facility located at our Colorado HQ. To learn more about our lab and clinical research programs, watch my video below:
In addition, to see the bells and whistles in our cell biology research facility, see the video below:
Dosing Stem Cells
How do you dose a same-day stem cell treatment based on bone marrow? The traditional way this has been done in the research literature is using CFUs. This is a culture-based metric that looks at the number of stem cells in the sample that attached and formed colonies (CFU-f, for fibroblast colony forming unit). The problem is that there is no way to get this information in time to have it alter your re-injection decision, as it takes a week or so to grow and count the cells. For example, if the stem cell dose is poor, there is no way using CFUs to know if the physician should only inject one site to maximize the dose. To learn more about CFUs, see my video below:
Another way to dose stem cells is to use a surrogate measure. This means another metric that roughly tracks the stem cell content of a sample. The one we have studied in knee arthritis is total nucleated cell count, or TNCC. The nice part about this number is that you can get it in time to make a clinical decision about the patient’s reinjection. For example, if the dose is high, treat more areas. To learn more about stem cell dose in terms of how CFUs and TNCC impact patient outcome in orthopedic stem cell procedures, watch my video below:
Can We Have Our Cake and Eat It Too?
Given that our research paper in knee arthritis showed that we can use TNCC to dose cells, we use this metric in the clinic every day. However, from a research standpoint, it would be great to have every single patient sample tested using a CFU metric or other things like multiplex microarray ELISA or flow cytometry to use in future research studies to learn even more about dosing. The only practical way to do this is to freeze a small portion of every sample of every stem cell-treated patient and then thaw and test those samples as needed at a later date. This allows us to have a huge “biobank” that we can mine for information at any time. Hence, I interviewed Dustin, one of our lab scientists, on this topic this week. This is that one minute interview:
The Lack of Dosing in the Field Is Appalling
Before I close today’s blog, I’d like to say that Regenexx has led the way in using dose in its stem cell treatments. Right now, forgetting about amniotic and umbilical cord “scam cell” treatments with dead stem cells, the percentage of physicians using bone marrow stem cell treatments that measure the dose of the therapy is far below 1%. Think about that for a minute, >99% of the orthopedic stem cell treatments you can get right now are either dead cells or, if delivered with live bone marrow, the doctor has no idea of the dose being applied.
To fix that issue, we provided our lab team to the IOF (Interventional Orthopedics Foundation) to teach the world outside of Regenexx how to count the TNCC of a stem cell sample. The good news? We’ve likely trained 50 or more medical providers outside of the Regenexx network how to measure the dose of what they’re injecting. The bad news? That’s just a tiny drop in the bucket of all clinics worldwide using these technologies.
The upshot? I personally can’t wait until this massive research biobank we’re creating can save a sample of every stem cell-treated patient who consents at the Colorado HQ. Why? The ability to learn more about how to best to dose these therapies will be transformative!