I saw a patient this week at our licensed, advanced-cell-culture site in Grand Cayman with an interesting story about the right and the wrong way to do cell therapy. Given the explosion in Providers offering this therapy who have taken weekend courses, it’s not surprising that as the clinic with the most experience in orthopedic stem cells in the U.S., we’re getting lots of patients who have failed elsewhere. Let me explain.
A Fat Graft Versus a Real Fat Stem Cell Treatment
As you may or may not know, the FDA has decided that if a physician digests and isolates the stem-cell-containing fraction of fat, this is a drug. While this distinction makes little common sense, given the nutty “treat every known disease” philosophy of many of these clinics, I can’t say I totally disagree with this approach as fat stem cell clinics are out of control.
To follow along with this post, you have to understand something that most physicians don’t—there is a distinct difference between a real fat stem cell treatment and a fat graft. Most physicians these days confuse these two, and as a result, many patients do as well. A fat graft is merely the fat that was harvested during a liposuction and then centrifuged to separate it into layers. Once the fat is taken from this mix, it’s called a fat graft. Even though a fat graft has stem cells locked inside it, those cells are trapped in the collagen matrix of the fat. Based on our lab research, they can’t be liberated and they die long before they can act in any way. This is why a cosmetic fat graft in the face has such a short life-span, typically only lasting, at most, a few months. The sequestered stem cells in the fat graft, which should help it survive, die long before they are able to do anything meaningful.
Compare that fat graft where the cells are trapped with one where the cells have been liberated and there is a huge difference. In the face, if you liberate the stem cells, the fat injection lasts much longer. How do you liberate the cells? You must digest the fat graft with an enzyme that breaks down the collagen, trapping the cells. You then centrifuge the mix, and after some wash steps, you take the cells from the bottom of the tube. This is where you’ll find a small percentage of liberated stem cells among many other cell types.
There’s just one problem with this type of stem cell soup—the FDA has stated that it’s an illegally produced drug. That hasn’t stopped hundreds of US clinics from offering it and floating the regulatory risk. As a result of this FDA issue, many doctors have been offering fat grafts and, in a colossal bait and switch, telling patients that this is a stem cell procedure. This is the issue in which a one of our patients was ensnared.
The Fat Stem Cell Bait and Switch
The patient I saw this week knows all about this fat stem cell treatment issue, as he explained to me after reading my blog. He had initially received a stem cell procedure from our Colorado clinic several years ago. His knee did very well for three-plus years, and then he was ready for another stem cell treatment. Being from California, he figured that he would find something closer to home, so he went to a local clinic offering fat stem cells. At first he didn’t know the difference described above, but when the treatment wasn’t working, he began to do some research. Our patient soon figured out that what his doctor had billed as a fat stem cell treatment was actually a fat graft. He also learned about our published research showing that adding a fat graft to a bone marrow stem cell procedure didn’t improve outcome.
The fact that our former patient’s doctor wasn’t being honest with him drove him down to our licensed advanced-culture site in Grand Cayman. This is becoming a common theme—patients who have tried other less-advanced stem cell therapies that fail and then come our way. One problem is that most physicians don’t know enough about stem cells to understand this distinction. Regrettably, this includes many doctors who offer stem cell therapies and consider themselves experts after taking a weekend course.
The upshot? It’s always amazing to me that doctors don’t know that a fat graft isn’t a fat stem cell treatment. However, our patient figured it out soon enough! Are you getting a real stem cell procedure?
The Regenexx-C procedure is not approved by the US FDA and is only offered in countries via license where culture expanded autologous cells are permitted via local regulations.