Medical practices that offer stem cell therapies fall into three distinct categories, levels 1-3 (see above). At the most basic level, the practice uses an off the shelf, bedside centrifuge to spin down samples. This is the same type of machine that produces PRP (platelet rich plasma). The advantage of this type of simple set-up for stem cell procedures is that it’s inexpensive for the doctor to get started. The downside is that it produces a much less sophisticated stem cell concentrate than could be produced by a cell biologist. At this same level of sophistication are other bedside kits being used to process cells at the bedside or in an operating room without a sterile hood. We have serious concerns about this type of processing, especially for fat tissue, as it’s often not processed in an adequate safe environment (like a biologic safety cabinet or “hood”), but instead by a medical assistant working on an open table in a patient room. The next level of sophistication up is a level II procedure, or a basic “in-office” hood. This isn’t a cell biology lab or facility, but instead a basic biologic safety cabinet placed into a patient room or operating room. The staff member performing the cell isolation or concentration procedure is usually a cross trained nurse or medical assistant (MA) and not a dedicated cell biologist. The advantage is that while a bit more costly, there’s an actual person processing samples. The downside is that the cross trained office staff member can at best follow a rote protocol and use a specific kit to perform the procedure. As a result, there isn’t a lot of customization of the sample for the patient or use of more than one simple procedure (i.e. the cross trained nurse may only know how to process a fat sample using a rote protocol and not be able to deal with blood or marrow). Another downside is that since there is no lab, more sophisticated checks on what’s being produced by the medical assistant or staff member are often not possible. As an example, cell viability checks to see if the procedures used by the doctor to collect and re-implant cells or that being used by the MA or nurse to process cells are usually not performed. Finally, there’s often no accreditation for the hood, such as ICMS certification for the facility. The third type of stem cell therapy setting is a level 3 Advanced Lab. This is staffed with dedicated cell biologists and not cross trained office staff and has advanced capabilities such as cell culture, flow cytometry, phase contrast microscopy (the ability to see and count cells without having to harm them by staining), cryo-preservation (the ability to bank cells and save quality assurance samples) etc… Not only can a higher quality cell based procedure can be performed, but varied procedures can be offered to best meet the need of the patient. In addition, things like checking the viability of the cells and the doctor’s harvest and re-implant procedures can easily be accomplished. In addition, these labs can be certified through the ICMS for meeting minimum standards for cell processing.
The Centeno-Schultz clinic has always used a level III lab facility with dedicated cell biologists rather than bedside centrifuges or in-office hoods with cross trained MA’s or nurses. The reason is that this allows us to offer patients the highest quality stem cell procedures and adjust the patient’s cell sample to meet their needs. While this is dramatically more costly than bedside centrifuges or hoods jammed into patient rooms, we believe the additional cost creates better stem cell solutions.
Tags: lab, procedure, processing, stem cell
