Fat Chance: Top 3 Stem Cell "Controversies"
POSTED ON 11/9/2015 IN Industry News BY Christopher Centeno
This past week it came to my attention that the fat stem cell boys were spinning it again "big" time at a conference. I guess when you're the new kid on the stem cell block, you have to work harder and cut a few corners of reality to get noticed. This seems like a great time to get into the top three misinformation channels being fed by the fat stem cell crowd to doctors and patients alike. When I started using orthopedic stem cells way back in 2005, I actually thought I might use fat as a source of stem cells. Back then this technology was truly new, as 99% of all mesenchymal stem cell research had been conducted on cells derived from bone marrow. After some basic research on PubMed, using fat seemed like a bad idea, as even the early studies in orthopedic fat stem cell use showed a superiority of bone marrow over fat. So we abandoned the idea and moved on to focus on bone marrow as a source of stem cells. In hindsight this was a good move, as the research has continued to show that bone marrow stem cells are superior to those from fat for orthopedic functions like chondrogenesis (cartilage repair). Fast forward a decade and fat stem cells have been revived mostly by plastic surgeons. This makes some sense, as these docs hoover an alarming amount of the white stuff from the ever expanding waistlines of the average American. Hence, why throw this stuff away when it can possibly be used as a regenerative medicine treatment? The only issue for physicians focused on orthopedics is not that fat stem cells could be a viable option for many diseases, but that the fabrications being spun by the fat stem cell crowd are almost believable. As Mark Twain once said, "There are lies, damn, lies, and statistics." Looking at the misconception mill from the fat stem cell camp makes me understand this Twain quote at a whole new level. When the deceptions you weave are tough to understand without advanced knowledge, even educated people will usually buy them all day long. Heck, even some of the docs spinning them don't know enough of the science or regulations to understand them. Hence, let's interject a little reality based thinking into the fat stem cell mess by taking on the top three fat stem cell whoppers:
- There are a thousand times more stem cells in fat than in bone marrow. As fairy tales go, this one has a princess and a frog, so it must be real (only if you're 6 and own a fairy outfit). The fat stem cell princess looks stunning in her dazzling gown when you compare the percentage of mesenchymal stem cells to nucleated cells in fat and bone marrow, as fat has a heck of a lot more stem cells as a percentage. However, the frog trying to make out with the proverbial weighty monarch has a problem - the really poor nucleated cell count in fat, which is about 100 times less than bone marrow. Hence, comparing the proportion of fat stem cells to bone marrow stem cells using nucleated cells can't be accomplished with a straight face (unless you have no idea what you're talking about). In addition, given that fat has a tiny absolute number of the hematopoietic stem cells compared to bone marrow that may aid in muscle repair, this comparison is about as ugly as the warts on the proverbial frog.
- IV stem cells are where it's at! We've known for a long-time that 97% of stem cells infused IV will end up being trapped by the lungs. Therefore this injection route could work great if the patient had a lung disease, not so great if you're trying to treat a knee or a hip. This is a problem for the fat stem cell camp, as they love IV injection routes. The reason is that it takes little specialized knowledge to set up an IV drip. While the average patient or even physician may feel that this is a safe injection route, it's actually quite the opposite. I've been hearing comments by physicians who practice in southern California of serious complications showing up in Emergency Rooms due to IV fat stem cell infusions. This is believable based on a few cases. We know that one Florida physician lost his license after a serious complications due to a fat stem cell IV. I also know from personal experience that the only death that we adjudicated as attributable to stem cell use while I served as President of ICMS (a stem cell registry body not related to Regenexx) was in fact a fat stem cell IV gone wrong that caused a fatal pulmonary embolus. Why? Stem cells love to stick to things (including themselves). This stickiness can be exploited for the patient's benefit in local orthopedic treatments (i.e. in getting cells to stick to a surface), but is a nightmare if the cells decide to clump in an IV infusion, leading to a travelling ticking time bomb known as a embolus.
- Doctors who use fat are following cGMP. What the heck is cGMP? It's the standard used by Pharma companies to safely make millions of doses of pharmaceuticals. As we found out the hard way, it's a standard that no clinic, operating room, nor surgery center in the U.S can come close to matching. It's also a standard that no purveyor of fat stem cells in the U.S. follows, despite paying lip service to the letters of the acronym. As an example, to be considered a cGMP cell production facility, a fat stem cell clinic would need need to do the following things:
A. The antiseptic used to clean the hoods that is already FDA regulated to kill X, Y, and Z contaminants would have to be "coupon tested" on samples of the metal and plastic from the hood and sent out for independent testing to ensure that it kills those things a second time.
B. Each sample of stem cells manufactured in the doctor's office would have to be tested for bacterial, fungal, viral, and endotoxin contaminants.
C. A pharma style cGMP compliance department would have to be set up in the doctor's office ensuring that a compliance professional is available at all times.
The other components of trying to turn a physicians office or a surgical center into a cGMP drug manufacturing factory would make any fat stem cell treatment easily cost $20,000-30,000 per dose. Despite this, safety wouldn't be measurably increased. Hence while it's fine that no fat stem cell clinic is cGMP, it's a bit funny to see some claim to using this standard based on their misunderstanding of what these initials mean.
The upshot? I'll never forget a reformed fat stem cell doctor who approached me at a recent lecture and who said that he had switched to bone marrow. He said he had initially switched out of fear of the FDA's increasing desire to classify fat stem cells as drugs. However, he noted that a side effect of his switch was that his arthritis patients were now getting much better results! In the end, the plastic surgery fat boys can spin this one till the cows come home, but perhaps just like Avis, that's because they need to try harder!
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