When we first began offering orthopedic stem cell therapy in 2005 as part of an IRB approved medical study, we were one of the few clinics in the world treating orthopedic problems with stem cells. When we began treating everyday patients in 2007, this was still the case. Now other clinics are beginning to offer basic cell therapies, most in plastic surgery and cosmetics, with a few clinics just starting to try orthopedic therapies. While we welcome the growth in cell based medicine, we also know that we’re world leaders in this area. As leaders, we set a higher standard for ourselves in all of the cell-based procedures we offer our patients.
Advanced Imaging Guidance for All Injections
Regenexx physicians use advanced imaging guidance to ensure cells are placed in the exact area of need. Studies have shown that even in easier to inject joints like the knee, experienced physicians injecting blindly in the office can miss the joint up to 14-45% of the time (depending on approach and the severity of arthritis). This means that injecting without imaging guidance (blind) will have stem cells get into the knee joint in some patients only about half of the time. Stem cells that aren’t in the knee will have no effect on the knee. The accuracy in other joints is often worse, because the joints are smaller or have more soft-tissue.
The diagrams above are from a recent study where the stem cells were placed blindly into the joint (intra-articular) versus exactly on the lesion (local adherent). The control was just injection of saline, which is far left. Notice that the purple stained cells on the surface are new cartilage cells (the blue cells under that are bone). The control shows little change. The intra-articular blind injection isn’t much better, and when the cells are placed directly on the specific damaged spot within the joint (far right local adherent) we see good cartilage repair. The same would hold true to injecting cells into a specific tendon, ligament, part of a meniscus, labrum, etc.
Additionally, one problem for collecting bone marrow stem cells is that the area at the back of the hip where they are harvested has some pitfalls. If the doctor performs this type of collection without imaging guidance (blind without using either fluoroscopy or ultrasound), the chance of taking cells from the wrong area goes up dramatically. In this area of the back of the hip, there’s a paper thin part of the pelvis that if tapped by the doctor, will almost always result in a blood collection only, rather than a bone marrow aspirate. Precision is the key to a Regenexx physician’s ability to maximize stem cells during the harvesting procedure. Regenexx physicians recently lectured on this issue to other physicians at the ICMS conference in Las Vegas.
Regenexx physicians leverage the power of advanced imaging guidance to ensure the best possible outcomes for our patients.
Advanced Cell Biology Facility and Dedicated Cell Biologists
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. The advantage is that while a bit more costly, there’s an actual person processing samples. All of the Regenexx Network providers have these more advanced set-ups rather than push button bedside centrifuges.
The third type of stem cell therapy setting is a level 3 Advanced Lab. This is staffed with dedicated cell biologists 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), fluorescent microscopy, ELISA, qPCR, 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.
The Centeno-Schultz clinic has always used a level III lab facility with dedicated cell biologists rather than bedside centrifuges. 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, we believe the additional cost creates better stem cell solutions.
All Patients are Tracked in a Patient Registry for Outcomes and Complications
A registry is simply a way to track a patient’s outcome and possible complications. The most common registries have been for bone marrow transplantation. In addition, in many countries, joint replacements are tracked through a registry. Many clinics offering stem cell therapy fail to provide enough tracking for patients. Some have noted that few if any clinics actually follow-up on patients at set time periods to determine the outcome of the procedure and make sure no complications have occurred. This is one of the criticisms leveled by scientists at stem cell clinics; rather than collecting all the data about their therapies (in a process like a registry) and reporting that data (when appropriate sample sizes have been obtained) in peer reviewed publications, most tend to cherry pick positive results and ignore negative results. The physicians who perform the Regenexx procedure have always required all patients to be extensively tracked. The reason? This data is invaluable not only to us, but to the world. As we collect more and more data in this registry, the true benefit and possible complications of stem cell therapies will be known. In addition, more importantly, they will be published. The physicians practicing the Regenexx family of procedures have published on the safety of their procedures in the National Library of Medicine and continue to collect data on all Regenexx procedures. So if you’re considering getting stem cell therapy for an orthopedic condition, your first question should be, how do you collect data? A simple phone call from a nurse after the procedure isn’t enough. If the clinic doesn’t use a registry to collect data and track patients for the long-haul, you should ask why.
Physician Leaders in Orthopedic Stem Cell Research and Publications
We are the physician leaders in stem cell therapy for orthopedic injuries in terms of research presentations, publications, and academic achievements. Take a look at the Research section of our site for published research, or browse the Blog and Recent Results section to see frequently updated reports on patient outcomes and summarized studies from our patient registry.