This past week I received a communication from a medical provider asking about the regulatory status of his “fat stem cell therapy”. While what he was doing wasn’t the production of a drug in this country, he also wasn’t using a stem cell therapy. He was shocked, as a sales rep had sold him a fat processing system that came with lots of fancy lab data showing it produced stem cells. What gives?
As I’ve blogged before, it’s the wild west of stem cells out there right now. This is made worse by the medical providers supplying these therapies barely knowing what a stem cell is or isn’t. Basically the depth of their knowledge comes from a weekend course or less. This creates a situation where sales reps with only slightly more knowledge can convince providers that almost anything is true, even when it isn’t.
In the specific case of fat stem cells, a regulatory mess has created a bizarre situation where if a provider wants to use real fat stem cells, he or she risks regulatory action and if the regulatory equation is solved, then a fake stem cell therapy is being offered. Let me explain. The fat that’s being billed as stem cells that’s being used right now by physicians is either SVF (stromal vascular fraction) or a simple fat graft. The first contains stem cells that have been liberated from their collagen matrix along with a huge number of other cells. While the orthopedics data is lacking for fat SVF containing stem cells, it is a true “stem cell therapy” in that there are stem cells in the mix that are available to be used by the body. However, the second type of therapy being offered (a simple fat graft) is not a stem cell therapy. While it’s true that fat has stem cells, the machines that process fat grafts make no attempt to free the stem cells from the collagen structure of the fat, hence those cells are not available to be used by the body. In our lab tests, those cells likely perish long before ever being able to act as a stem cell.
In Europe, fat stem cell processing machines abound, but in the U.S., because of a regulatory morass, there are none. A great example of this duality is a company called Cytori. For the last decade, they have had a nice machine to automatically isolate fat stem cells by digesting away the collagen. In Europe this machine quickly received its device CE mark and went into widespread use. In the U.S., the machine was blocked for regulatory approval as its fat stem cell output was declared a drug by the FDA. This company is still in the process of getting FDA approval for its first drug indication in the U.S., which could still take many years.
In the U.S., some device manufacturers and aggressive sales reps have begun trying to solve this regulatory calculus with an interesting solution. They’re hawking machines that minimally process fat (i.e. don’t liberate any stem cells) and getting these approved as simple fat graft machines, but then convincing medical providers behind closed doors that they are really fat stem cell machines. To do this, they put out lab data showing that their machines can process fat that ends up with X number of stem cells inside it. What they say in the fine print (that goes unnoticed by most physicians) is that to get these numbers they had to digest away the collagen and liberate the stem cells, which is fine in a lab test, but illegal in a clinical setting.
The upshot? This is an interesting fat stem cell bait and switch. I’ve seen many otherwise smart medical providers fall for this and the fact that many don’t understand these differences brings up a concerning reality about the state of stem cell therapy. Most medical providers have little knowledge of what they’re doing or why. Rather than solving the regulatory mess, the device manufacturers are using this ignorance to their advantage, selling a raft of new devices as fat stem cell machines that are incapable of producing a single fat stem cell. My concern is that patients are paying out of pocket for a stem cell treatment without actually ever getting one.