Running Doc stem cells knowledge and reporting inaccurate… Recently, I came across an article about stem cell treatments for running related injuries written in a newspaper blog. The author was the “running doc”, a family physician who specializes in the disorders of running. The “running doc” told his readers that he only believed in “Evidence Based Medicine”, which was a bit concerning at the outset as there isn’t much level 1 evidence (which is the high level of research evidence needed to become “evidence based”) in stem cells or platelet therapies. However, I kept an open mind, as if the article concluded that there was no such evidence for PRP (platelet rich plasma) or stem cells, it could still be accurate. However, much to my surprise, the yardstick for evidence based medicine was thrown out the window. The running doc concluded that PRP was evidence based (the actual science shows that the data is no where near level 1 and conflicting) and that “stem cells” for use in orthopedic injuries were evidence based as well (the evidence in this area is at best level II). In fact, the II rating for knee arthritis research was based on publications by our group on the Regenexx-C procedure (large case series versus an untreated comparison). What I read next was truly mind boggling. The running doc then went on to state that he couldn’t recommend the Regenexx procedure because it wasn’t evidence based (but did recommend “stem cell” procedures). Huh? Since we’ve published most of the real patient data and other “stem cell” procedures (simple bedside centrifuge based) either have much less published data (a single case report) or nothing published, this statement was backwards. I then wrote the running doc thinking that perhaps he just didn’t know that he was referring to publications on Regenexx-C when he said there was any evidence that stem cells were effective. My e-mails regrettably only generated a series of responses that demonstrated that his position was entrenched and that he wasn’t open to an edit of his post. It’s unknown why the running doc seems entrenched towards the manufacturers of bedside centrifuge machines, but I felt it important to share our formal response to his post with the public. That response is below:
Dear Dr. Maraham,
First, I want to thank you for recognizing the Regenexx procedure in your recent post on innovative sports medicine procedures. However, there was some confusion on a few points I’d like to clarify:
-We have two stem cell procedures, one that produces Mesenchymal Stem Cells (MSCs) through culturing cells for two weeks (Regenexx-C) and a second that uses a same day procedure, stem cell isolate similar to bedside centrifuge prepared BMAC (Regenexx-SD for “same day”). The FDA thought that culturing cells was a drug, but has reviewed our same day procedure and found it to fit within their regulatory framework under the same surgical procedure exemption (un-regulated on 21 CFR 1271.15(b)).
-The goal with our cultured stem cell based procedure since 2005 has been to innovate, not to “skirt” any regulation. We obtained many legal opinions before beginning that stated we were practicing medicine and not producing a drug by culturing cells. Like any new innovation, we went through two years of an HHS registered IRB to ensure patient safety and our practice paid for hundreds of research grade 3.0 T MRI’s. During this two year plus period from 2005 until late 2007, we provided free care to patients and every patient we have ever treated with stem cells is tracked for complications and outcomes through a registry.
-We have challenged the FDA’s regulatory authority over our cultured procedure and a recent “Order to Show Cause” slapped on the FDA by the judge in our suit against the agency suggests that the judge agrees (see attached order). In addition, we don’t agree that the regulation of individually consented risks as a drug is good for patients, see our publications on this topic of stem cell regulation (publication 1, publication 2).
-After just having completed two book chapters this past year on the use of stem cells in orthopedics (link to Centeno book chapter on the use of stem cells in orthopedic injuries), I’m not sure I know of any data on stem cells that would qualify as level 1 evidence. In fact, most of the human data out there has been published by our team on the Regenexx-C procedure. For example, we have published two large, long-term safety papers (n=227 and n=339) showing that the cultured procedure is safer than surgical alternatives.[1, 2] We have also published on the outcome of a large dataset of knee arthritis patients (n=155) versus an untreated group.We know of no similar safety or large efficacy case series with an untreated comparison published in diseases suffered by runners with bedside centrifuge created BMAC. In conclusion, the claim that there is “evidence based medicine” supporting BMAC isn’t accurate (the BMAC literature is at best a level 3-4), while the Regenexx-C procedure has approximately level 2 evidence supporting its use.
-Our clinic/lab and our network providers offering the same day procedure in the U.S. operate at a higher standard than a bedside centrifuge based stem cell system. Unlike these machines, the providers on our network not only measure the nucleated cell count of each processed sample, but they also send quality assurance samples to our advanced clean room lab for verification of stem cell content (using the CFU culture method). Using a bedside centrifuge, there is no way to ensure that the BMAC that comes out of the machine indeed contains a high concentration of stem cells as everything from the bone marrow aspirate technique to the density of the bone marrow aspirate will impact the output.
-Your article mentions that we have lacked transparency as to what we’re doing. Again, this isn’t accurate. In fact, for our cultured procedure, we’ve published the methods in painstaking detail (see above referenced papers). For our same day procedure, we use the same technique widely published in the medical literature to isolate a buffy coat fraction from a bone marrow aspirate. In addition, we have tested our marrow concentrates vs. commercially available BMAC (as created by the company rep), and they have been found to have 3x better nucleated cell concentration. Finally, we use a proprietary platelet rich plasma mix with the same day procedure that has been shown in the lab to promote stem cell growth better than typical PRP.
As you can see, you article makes several statements that are demonstrably untrue.
The Regenexx Provider Team
1. Centeno, C.J., et al., Safety and Complications Reporting Update on the Re-implantation of Culture-Expanded Mesenchymal Stem Cells using Autologous Platelet Lysate Technique. Curr Stem Cell Res Ther, 2011.
2. Centeno, C.J., et al., Safety and complications reporting on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther, 2010. 5(1): p. 81-93.