By Christopher J. Centeno, M.D.
We have noted an explosion in the number of stem cell clinics over the past several years. There’s not a day that goes by that I don’t see several new ones pop up on the radar. On the one hand, as somebody who has been treating orthopedic patients with stem cells since 2005, it’s good to see more physicians jumping on board. In addition, as an advocate for the use of autologous stem cells as the practice of medicine, I’m gratified to see more doctors who believe the same thing. On the other hand, I have a serious concern that the explosion is placing patients at risk. Let me explain.
Back in 2008, acknowledging that autologous stem cells were a surgical procedure and not a drug, I and others felt that physicians needed to police themselves by creating treatment guidelines, a treatment registry to track complications and outcomes, and an accreditation program. The model for this endeavor was the College of American Pathologists program that was used to accredit in-vitro fertilization clinics. This led to the creation of ICMS. Regrettably, as the first head of that organization, I realized that few of my colleagues were willing to do these things. Ultimately I passed that rock onto the next president so he could pursue those lofty goals. That led to ICMS starting a program that’s in process with AABB, to at least try and close the accreditation loop. If that comes to pass, that will be a great advance for the field.
In the meantime, I’ve seen stem cell clinics popping up like weeds in a garden. In order to treat orthopedic patients, while we have never sought to adhere to drug approval nor manufacturing guidelines, we have spent millions on an expensive infrastructure such as our own treatment registry that uses university based CRO software, a clinical and lab research team who work out of a university quality facility, a 1,000 square foot ISO class 7 clean room, a regulatory consultant, a strict candidacy grading process, a publication process, etc… However, none of my colleagues have again chosen to do any of this, so this is again upsetting.
When we train a medical provider to use stem cells for orthopedic therapies, we do so with great care, turning down about 8-9/10 physicians who want to learn because of lack of training. The explosion of physicians using stem cells to treat pretty much any ailment is being largely driven by courses being given to any willing provider by a few companies selling kits to process adipose stromal vascular fraction using digestive enzymes. While the FDA Tissue Reference Group has clearly outlined that this beside process creates a drug (a decision I strongly disagree with), these physicians are being told that this ruling doesn’t apply to them. This is despite several adverse letters written to physicians who planned on processing adipose tissue at the bedside. These courses are also short affairs where often the basic science behind stem cells isn’t taught in depth, resulting in SNAFUs like the recent situation where a plastic surgeon injected mineral bone components with stem cells into an eye lid, which created bone. In this example, the simple message that stem cells will follow local microenvironment clues either wasn’t taught or wasn’t learned, hence the concept that flooding an area with a huge bone signal might cause adipose stem cells to create bone was lost. This places patients at risk. In addition, none of these educators track patient outcomes, nor do they create the basic science research. None publish their findings nor require their graduates to track complications. Some don’t even require simple biologic safety cabinets, instead allowing physicians to process cells at the bedside in open systems.
The number of stem cell clinics has also grown so fast that it is approaching a tipping point beyond which, no amount of FDA regulation will make a dent. As a common sense example, the FDA surveils about 10,000 drug factories worldwide that produce million to billions of doses each. Hence there is a surveillance efficiency of visiting a Pfizer drug factory as with one visit, you can spot check the safety of a billion pills that may end up in hundreds of thousands of different patients. However, that efficiency drops off a cliff when you consider that there are 1M US physicians who would only likely ever process a few hundred doses of autologous cells a year. Now to keep anywhere near that same surveillance scale (1 billion doses), you need to visit not one factory, but tens of thousands of physician offices. There is no way that the FDA, without growing to gargantuan proportions, could ever accomplish this goal.
As Mary Ann Chirba has aptly defined, we need new regulations to deal with these issues. Since FDA has no authority over the practice of medicine, perhaps these regulations need to come from state medical boards or state public health departments? If not, then perhaps an FDA registration system that acknowledges the difference between a doctor’s office and a drug factory makes sense? In the meantime, I fear that there’s a wave of regulation coming that physicians won’t like-it’s called the local malpractice attorney. New procedures in medicine that take on a “Wild West” mentality are usually not regulated by some federal agency, but by the civil tort system. This then leads to guidelines that doctors must follow to get insurance and avoid law suits. So in the end there will be “regulation”, just not the type we all planned.