A Regenexx Network physician recently sent me marketing materials from a fat stem cell company that were being sent to him by a patient. The patient has severe hip arthritis and based on his history is frankly unlikely to respond to any stem cell based treatment. I read the materials with interest, thinking to myself that without a decade spent reading and understanding the medical literature, there would be no way for a patient to recognize that most of the material was smoke and mirrors. So let’s take a look at the information and break it down.
First, this company treats everything from MS, to ALS, to arthritis with stem cells. I’ve blogged before about this phenomenon. Perfecting treatment protocols for a few types of tissue (like bone, joint, ligament/tendon) can take an entire career. Trying to perfect these protocols for 20 different diseases which have little in common reminds me of a saying my mother used to use, “Jack of all trades and master of none”.
The marketing material I’m going to break down today is entitled, “Company Name Osteoarthritis Studies”. First, some background is needed. I know this company well and have spoken to the PhD that runs the clinic in Mexico. He has told me that he’s “not a researcher” when I discussed that it’s the obligation of anybody using a new therapy to track and report their data. Hence, the company has never reported any outcome nor complication results of any treated patients where an entire data set (not just a single endorsement) was revealed to the public. They have also never published a single research paper in the peer reviewed medical literature. This is in stark contrast to Regenexx, in that we:
1. Run a large registry where multiple full time employees use CRO quality open source software to track the complications and results of thousands of patients using standardized and validated questionnaires.
2. Have a full time bio statistician and medical research staff to analyze that data.
I’ll list the rest of the claims in bold:
A. Fat stem cells are better than bone marrow stem cells for osteoarthritis because they’re more anti-inflammatory. I’ve blogged on this extensively. In fact, for an osteoarthritis application, about 10 papers where fat and bone marrow cells were compared showed that the bone marrow cells were more suited to the application. The big issue with fat stem cells is that the closer the cell source is to the target tissue to be repaired or helped, the more likely it is that the cell will work. So bone marrow cells are involved in helping and maintaining joints and the fat cells from your stomach are not.
B. Fat stem cells are easier to access and more plentiful. I’ve blogged on both of these issues. First, a lipo-suction to obtain fat stem cells is about 1,000 times more dangerous than a bone marrow aspiration. See this link for my physician eye view of why lipo-suction to get fat stem cells is a procedure not for the faint of heart. Second, I’ve also blogged that fat stem cell content claims are wildly inflated. In addition, the Regenexx-SD proprietary two fraction stem cell isolation obtains many more times stem cells than bedside centrifuges can muster.
C. Mesenchymal stem cells (MSCs) are the same as “Processed lipoaspirate cells (PLA)”. Huh? The best way to better understand why this is a nutty statement is to read my blog on how stem cells are counted. However, for a brief tutorial, MSCs are the base stem cells in any tissue and always make up a tiny fraction (in bone marrow and fat) of the total cells in a sample. PLA is also widely known as “stromal vascular fraction” or SVF. Out of every 100 cells in SVF/PLA, only a tiny fraction (between 1 to 3) are MSCs, so conflating that the (SVF) PLA count equals the MSC count is not correct and pretty sneaky. In addition, since liposuction is a brutal process, the poor viability of those cells means that for every 2 or 3 MSCs in (SVF) PLA, 1 or 2 cells is dead on arrival and useless.
D. There is great and extensive research data showing that fat stem cells (PLA) are effective for osteoarthritis. I’ve also blogged on this topic as well. There are a handful of studies for fat stem cells and SVF/PLA and orthopedic conditions compared to a huge amount for bone marrow stem cells or concentrate. I’ll break down the studies listed:
I. A three month study that showed that fat stem cells can help knee pain and function (remembering that the patient in question has severe hip arthritis, a different disease than knee arthritis). First, the “study” being cited doesn’t refer to a research study published in the peer reviewed literature, but a talk presented at a trade show used to attract business investors, The New York Stem Cell Summit. Hence, it’s impossible to really dissect the study. However, the marketing material makes clear that the presenter only showed improvement in knee arthritis at 3 months, which is about what you get from a steroid shot, so not so ground breaking. As a comparison, I recently blogged on a ten year plus follow-up on patients treated for rotator cuff tears with bone marrow stem cells.
II. A second study where patients experienced reduced knee pain and increased function for 6 months and better knee cartilage. The first thing that struck me is that the duration of effect of this study-6 months-is about the same as a much less expensive platelet rich plasma shot. More concerning is the fact that this study has no listed title in the citation, only a journal and month. I went to the journal web-site and checked every abstract in that issue, but didn’t find a single study on this topic. The material could be referring to a study by a Korean orthopedic surgeon, Jaewoo Pak, but botched the citation? First, Pak is a pioneer is using adipose stem cells for orthopedic applications and I applaud him for following the path we have taken, publishing his results. The paper is published in another journal in that same month and year. He injected SVF/PLA and hyaluronic acid and didn’t use the same cell processing protocol that is used by the Mexico group, so who knows if the “stem cells’ the Mexican clinic is injecting are the same as what Pak injects? The paper is about a single patient case report of a patient who was better at 18 months out after the injection of SVF to treat a meniscus tear. There was a small study published in Arthroscopy in 2013 which also could be a match for the botched citation. This was 18 patients who underwent a completely different apples and oranges procedure than the one offered by this clinic. In fact, the stem cells used were obtained from the fat in the knee, a completely different cell source and type than stem cells from belly fat.
III. A third study also demonstrates amazing things for the use of belly fat stem cells when used to treat knee arthritis. This citation also has no title or authors. When I looked up this study, I now realize there is a method to the madness of leaving off the research paper titles of many of the citations (while including others). The title of this paper again focuses on an apples to oranges comparison. This study tracked 25 injections in fewer patients and the cells are again derived from the fat in the knee that is surgically removed, and not the type of fat stem cells that can be obtained from a belly lipo-suction.
IV. It’s important to note that there are no severe side effects in any of these studies. That may be true, but first, they don’t report on the same cell source or type of cells being used by the Mexico clinic. In addition, even if you add all of these patients up, there’s less than 50 subjects followed for from 3 months to 18 months. We’ve published on-line a safety report of 1,104 patients followed for up to four years using our specific bone marrow concentrate protocol (Regenexx-SD). We’ve also published in peer reviewed journals our experience with 339 patients treated with cultured mesenchymal stem cells and followed-up for up to four years. In addition, I just blogged on a large study out of Europe showing excellent safety profile for more than 1,800 patients treated with bone marrow stem cells with 12+ years of follow-up.
In addition, the citations listed after this claim also have no titles. As a result, I had to look them up by going to the individual journal web-site. The first journal listed is Stem cell Research and Therapy. The journal doesn’t list editions by month, so I had to use the search function. Suffice it to say that there is no adipose stem cell arthritis or orthopedic based human safety paper that has ever been published in this journal. There was a paper that showed that adipose stem cells weren’t ideal for cartilage repair because they can inhibit new blood vessel formation in cartilage. Once I scanned through the listed search results, I did find the paper that was cited. It turns out it has nothing to do with adipose stem cells (the reason why the title was left off the marketing materials), but instead focuses on bone marrow stem cells. One of our research papers is cited in the work.
The upshot? Yikes! When I was sent this marketing sheet at the end of last week, I knew it likely had some issues, but I didn’t think they would be as systemic as what I found. There are a number of deceptions from the invasiveness of the lipo-suction harvest method to cell number to quoting papers that have nothing to do with the therapy being used in Mexico. This is a common problem with clinics offering fat based stem cell therapies as there is scant evidence that this therapy is effective for arthritis at this point. Rather than conceding that fact, most clinics will do what you see here-quote research that looks great on the surface but falls apart once you dig just a little deeper!
About the Author
Christopher J. Centeno, M.D. is an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. He is board certified in physical medicine as well as rehabilitation and in pain management through The American Board of Physical Medicine and Rehabilitation.…