Take care, beware, of the green eyed monster with the purple tail

In the past 6 months there’s been an explosion of clinics offering “stem cell therapies”. While I welcome this increased interest and availability of cell based therapies, it is only as long as these new clinics use physicians trained to understand the diagnoses and procedures they wield and they operate in a safe manner. The biggest explosion has been in adipose (fat) derived stem cells, mostly used for cosmetic purposes. However, I’ve also noted a precipitous rise in the non-specialist treatment of arthritis with stem cells. Most of these clinics  use family physicians without specialized musculoskeletal training or cosmetic surgeons injecting joints (a cosmetic surgeon injecting a joint is like an orthopedic surgeon injecting cosmetic fillers). In addition, to liberate stem cells from the adipose tissue, many of these clinics use an off the shelf “Shaker Kit” being distributed in the United States as “Research Use Only”, but with the intention of being used clinically in patients. The kit contains a simple emulsifying agent (Lecithin) and a container. The doctor takes a liposuction aspirate, chops it up a bit (usually at the bedside), and then adds this chopped up fat to the container and adds an emulsifier. The mixture is then shaken (not stirred) and then centrifuged. The Lecithin breaks down the structural component of the fat so that the stem cells in the fat (along with many other cell types) are released. The doctor then manually removes the fraction of the centrifuged and enzyme digested fat that presumably is rich in stem cells. These cells are then exposed to a LASER to “activate” them and then finally injected. I say presumably containing stem cells, because there is no lab used to confirm what’s actually being isolated, if the stem cells are dead or alive, or if there are any stem cells at all. Since how the cells are processed will impact if viable stem cells are obtained, simply giving the doctor a training course on how to perform liposuction and use the kit won’t suffice. There has to be some validation that the doctor or medical assistant using the kit is actually able to obtain stem cells out of the process-which should be checked by a lab until the doctor demonstrates competency. There also has to be training about how and when these cells might be useful to the patient, which clinical diagnoses are more likely to be helped, and how to deploy the cells. These later details are often left out by the kit vendors. Finally, any physician using an “investigational” procedure has an ethical obligation to enter his or her patients into a registry that can track the patients for outcomes and complications. Simply applying usual in clinic follow-up care or having a nurse call the patient after the procedure is not nearly enough, as by definition, an investigational procedure still has unknowns. None of these last steps are often followed by the doctors using these “Shaker Kits” or many other doctors processing fat in their offices. Last of all, the non homologous use of tissue is illegal; not FDA approved. That’s why if you are seeking to avoid surgery for arthritis, the stem cell source has to be from the skeleton/bone marrow.

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