A Internet-based research study was published this week that was covered widely in the news that said we have more than 570 stem cell clinics in the United States. Its thesis is that while the scientific community has been focused on clinics offering embryonic stem cells in Asia and Russia, the US stem cell scene has exploded. The piece goes onto to discuss that stem cell treatments are unproven and risky. While you might think I would be 100% against an article like this, while there is some fearmongering and throwing the baby out with the bathwater, I tend to agree with the article’s main thrust—the physician-run stem cell world is out of control. So this morning, I’d like to review the study, provide some historical context for how we got here, and suggest solutions.
Reviewing the Article and Separating Fact from Fearmongering
The scientific community that earns its money through basic science and clinical research doesn’t like physicians using stem cells; it never has. Why? Stem cells were discovered in university labs, and as of this morning, university scientists (and a few others) have churned out 41,576 separate studies published in the US National Library of Medicine on mesenchymal stem cells; 70,341 on hematopoietic stem cells; and 42,108 on embryonic stem cells. Add in the studies on the many other different stem cell types, and there are almost 200,000 studies on stem cells—most of which are basic science. For perspective on how we got there, McAllister et al put it best:
“On one end of the spectrum is the academic community. Through societies such as the International Society for Stem Cell Research, this community tends to echo the FDA’s conservative stance, and encourages continued bench-top and animal research. While justified in many cases, we cannot ignore the potential financial self-interest served by this message. That is, the NIH funded academic community is well served by a regulatory policy that promotes a longer and basic research intensive developmental path. Indeed it is no surprise to see the International Society for Stem Cell Research closely linked to the war on stem cell clinics [17,105].”
To put that financial incentive to keep stem cells out of the hands of physicians in perspective, consider that for the drug amoxicillin, as of right now, we have 16,422 studies listed on what is the most commonly prescribed antibiotic in the U.S. Meaning despite millions of worldwide prescriptions for this drug, we know about one-third as much about this drug as we do about mesenchymal stem cells. The situation gets even worse if you compare stem-cell-basic-science research to a common surgical procedure, like knee meniscectomy, the most common elective orthopedic surgery in America where we have 2,132 studies.
So when you read this new article, it’s important to put its tone in context. Academics will never support physicians using stem cells as the practice of medicine because that kills the NIH stem-cell-basic-science golden goose. Just like in medicine, in academia, money talks.
The new study also does a good job of fearmongering. For example, while almost all of the stem cells being used by physicians in the U.S. are autologous cells (from the patient) derived from bone marrow or fat, the study brings up cases where patients received embryonic stem cells overseas, which is a stem cell type that, unlike adult stem cells, has a known teratoma risk. Meaning that while there is no known risk that adult stem cells cause cancer (we’ve published the largest study on this issue, and Hernigou has also published a large paper), it is well known that embryonic stem cells (from an embryo) can cause a weird type of tumor known as a teratoma. The study makes no attempt to educate the reader on the differences, so its discussion of patient cancer risk is intentionally hyped.
Where I Agree with the New Internet Study
Since I was there at the very beginning, being the first to use stem cells to treat orthopedic conditions in the U.S. and producing many other worldwide firsts, I saw this train wreck happen in slow motion. You see, while the scientific community is heavily financially conflicted and loves to fearmonger, it’s not wrong about the out-of-control physician stem cell space. Things have gotten out of hand.
I’ve blogged quite a bit on all of this before:
- My Regenera Global discussion on the Good, the Bad, and the Ugly of Stem Cells
- Treating everything—my discussion of how fat-based stem cell clinics delivering IV treatments have begun to treat many conditions for which we don’t even have a single animal model showing efficacy for fat stem cells
- The amniotic stem cell scams sweeping the nation
We have hundreds of stem cells clinics offering to cure everything from autism to impotence to ALS. None of these clinics are reporting any data on safety or efficacy. Almost all of them throw studies on their websites that look like they support what they do, but the studies are about other stem cell types the clinic doesn’t use. There are large for-profit organizations teaching how to use stem cells to treat almost any known disease and that will educate anyone with a credit card and heartbeat. There are plastic surgeons who are offering to treat a panoply of diseases in which they have zero expertise. There are sales reps selling amniotic stem cells in a vial to physicians gullible enough not to fact-check that claim, where what’s really in the vial is 100% dead cells! Out of hand…
The Historical Context of How This All Got So Screwed Up
So how did we get here? Around 2009, after we had been using stem cells to treat orthopedic issues for four years, there were few physicians using stem cells worldwide. I put together a physician-run organization called ICMS (The International Cellular Medicine Society). The goal was to herd the cats and try to self-enforce guidelines on stem cell use. The good news is that back then, the number of stem cell clinics in the U.S. numbered only 10–20, and the number of worldwide clinics was a similar number.
What I soon found out was that many of these physicians didn’t want to have to use their resources to collect data. They also had no interest in following guidelines of any kind. The fat-stem-cell crowd believed that any regulatory barriers that might come up would never involve them. When ICMS brought up that they should slow down on the staggering number of diseases they were beginning to treat and collect data to ensure that these therapies were really promising, that rigor got in the way of the business model. Thus began the train wreck in slow motion.
Solutions for Cleaning Up the Mess
The guidelines we have always used at Regenexx were born in that early crucible of ICMS. They haven’t changed much and still apply today. These are:
- Candidacy Grading—All patients deserve to know if they are a good, fair, or poor candidate for the stem cell procedure. Not everyone is a good candidate. Regrettably, at most clinics you’re a good candidate if your credit card authorization clears.
- Expert Treatment—The doctor who treats your knee had better know a lot about knees, just like a cardiologist should treat your heart, a pulmonologist should treat your lungs, and so on. Far too often in stem cell clinics, the doctor who is trying to treat the complex condition that requires a specialist has no expertise in that area.
- Animal Models for Investigational Care—As discussed above, the Internet is rife with fat-stem-cell clinics that place research on their websites that seem to show that condition X can be treated with fat stem cells, but the studies listed used another stem cell type. For most of the conditions being treated at IV-based fat-stem-cell clinics, we have no data at all that fat stem cells will help.
- Data Collection via Registry for Every Treated Patient—Every patient must be tracked in a formal registry. This just isn’t being done at all at this point. While we have a few clinics that are sending some postprocedure questionnaires, almost none use a formal process to ping patients at set time points with validated questionnaires. How do I know? Recently, a colleague called stating that he knew of a few other clinics that were tracking stem-cell-treated patients in a registry and wanted to get information about what we were doing. I sent a 20-item white paper on the methods that the IOF used to track patients (the 501c3 we donated our registry infrastructure to last year). In the end, it turns out none of the other physicians were really using any registry methods to track patients.
- Transparent and Peer-Reviewed Publication of Data—The data that’s collected, where appropriate, needs to be published. While we have a few brave souls who are spending their time and resources to present and publish their data, this is more often in the orthopedic field. This is much less common in the wild west of treat-everything, fat-stem-cell clinics.
The upshot? While the scientists in this area do have financial conflicts and often fearmonger, for the most part, they’re right. The physician-run stem cell space has spiraled out of control. If these clinics had followed the five guidelines that ICMS introduced in 2009, we would have hundreds of publications on the use of stem cells in many diseases and a solid argument could be made that patients were being helped with minimal risk. Regrettably, treat-everything clinics couldn’t be bothered, so now I need to side with the scientists: something needs to be done.