Many years ago I coined the term “Stem Cell Wild West.” Since then I’ve lectured on this topic many times. It seems like these days, you can’t go a month or more without seeing yet another piece on the out-of-control stem cell treatment space. Hence, it wasn’t surprising to see a piece from the Washington Post this morning on what I call “Fat Stem Cell Miracle-Cure Clinics.”
You Just Can’t Make This Stuff Up
I’ve covered many different parts of the stem cell wild west these past few years, from these miracle-cure fat clinics to the magic-stem-cell chiropractor down the block. Right now, the negative press wave is about fat stem cell clinics, and this was begun by the blinding of three patients at US Stem Cell in Florida. This culminated in two warning letters, one each to US Stem Cell and another to Cell Surgical Network (CSN) and then an FBI raid at a joint CSN and Stemimmune site in California, where they were trying to cure cancer by using the smallpox virus and stem cells.
I have been shouting from the rooftops for quite some time now that we have a serious problem. This is my lecture from last year’s MedRebels conference in Austin, Texas:
Irresponsible Medicine Is Irresponsible Medicine
Whether or not you’re using stem cells or FDA-approved drugs, bad medicine is bad medicine. I experienced this many years ago with the fat stem cell crowd while reviewing an application for a protocol that used fat stem cells to treat urinary incontinence. While in the meeting, I quickly ran a US Library of Medicine search and found no studies in this area, not even an animal model that showed it might work in humans. I blocked the research proposal on that basis. However, this has been common with the fat stem cell set who are treating any number of incurable diseases.
As an example, I blogged on a review of the website of one of these clinics that claimed that it listed many studies showing that their fat stem cell treatments were effective. Regrettably, when I dug into those studies, almost none of them had anything to do with fat stem cells. Meaning that what was listed was classic “bait and switch” advertising.
The FDA Status of Fat vs. Bone Marrow
The FDA announcement in August of last year and the recent coverage in multiple news outlets don’t represent anything new. In fact, ever since a warning letter was sent out in 2012 by the FDA stating that breaking down fat to get the stem cells out constituted drug manufacturing, the entire medical community knew this was a problem. In fact, after several more letters had been sent, I confronted many of these same clinics in the Washington Post piece with these facts, and all refused to acknowledge the problem. Hence, the regulatory status of breaking down fat has been known for at least 6–7 years.
Compare and contrast this to minimally manipulated bone marrow, which has never been an issue for the FDA. In fact, there has never been a single FDA warning letter sent out for this category of stem cell use. In addition, FDA has stated in writing that it considers orthopedics in a low-risk category.
How Regenexx Has Always Been Different
I can’t tell you the number of times that I have been approached by friends and relatives to treat everything from spinal cord injury to stroke to multiple sclerosis. Each time, my answer has been the same: “That’s outside of my area of expertise.” Which brings up another point that I have continuously driven home in more blogs and lectures than I can count. When physicians treat outside of their specialty areas, they increase patient risk. For example, it was brought out in the Post piece that the clinic in Georgia was run by an ER doctor. What does an ER doctor know about treating MS or spinal cord injury? Next to nothing.
Making sure that the doctor who is treating the patient is an expert in the area of medicine being treated is key. In fact, for this reason, we have turned down hundreds of physicians who were interested in joining the Regenexx network. That has included ER doctors, neurologists, cardiologists, nurse practitioners, PAs, and a long laundry list of medical specialties that have no experience or training in treating musculoskeletal injuries. In addition, we require standardized additional training through a nonprofit (Interventional Orthopedics Foundation) to ensure that every doctor is trained in the same advanced procedures to precisely place cells.
Another big difference is that Regenexx has always had a registry to track patient outcomes and complications. Unlike other groups (including one of those mentioned in the article) that rely on physician reporting of complications (who tend to under-report the actual issues), ours has always directly pinged patients. To that end, in 2016 we published the world’s largest safety paper in orthopedic stem cell use.
Another huge difference between Regenexx and these groups is publications. As you can see from our research page, we have published 23 peer-reviewed papers on what we do. In addition, we usually get out another 2–3 a year and just completed our first randomized controlled trial (RCT) on treating knee arthritis (submitted for publication) and have two more RCTs in the works.
Finally, one of the things that has always set Regenexx apart is candidacy grading and transparency. We level with patients who won’t do well with our procedures. Since 2005, we have told thousands of patients that they were poor or only fair candidates for our procedures, essentially discouraging many from getting the procedure. Why? That’s real medicine. Stem cell procedures aren’t magic. In addition, we transparently publish live registry data online every month. This page has the latest info where a prospective patient can compare real outcome info on everything from ankles to hips to knees.
While there are many other differences, just these five have always set us part:
- Focus on orthopedics
- Only including physicians with a musculoskeletal subspecialty in the network and then requiring additional standardized training for many
- Registry tracking of patient-reported complications and outcomes
- Consistent publication of our results in the peer-reviewed literature
- Candidacy grading and transparency
The upshot? I, too, like the Washington Post, hope that the FDA moves to clean up the stem cell wild west. It’s time to get rid of the fat-based miracle-cure clinics as well as the magic-stem-cell chiropractors. In the meantime, at Regenexx we will continue to use these technologies responsibly to bend the orthopedics cost curve downward.