Regenexx FAQs

The Regenexx procedures performed in the United States are compliant with CFR 21 Part 1271 and fall under the same surgery exemption discussed in 1271.15 (b).

All of the Regenexx Stem Cell and Blood Platelet Procedures performed in the U.S. today are same-day procedures that are compliant with CFR 21 Part 1271, falling under the same surgery exemption discussed in 1271.15 (b). Unfortunately, there still remains some confusion about Regenexx, largely as a result of a few individuals who have written about our case against the FDA throughout the last few years, but who did not fully understand that the case relates only to the Regenexx-C Procedure. This single procedure, which is different from the procedures now performed in the USA, is only available in the Cayman Islands through an independent vendor who has licensed the procedure and has not been performed in the U.S. since August of 2010. fda_page_graphic Regenexx FAQs

What’s the Difference Between these Procedures?

regenexx_compare Regenexx FAQsAll of the procedures performed in Colorado and throughout our U.S. Regenexx Procedure Network are same-day procedures. This means that the patient’s cells are harvested in the morning, isolated and processed, then re-injected into the patient’s injured area – all within a period of a few hours. The Regenexx-C Procedure, which is only performed at Regenexx Cayman, involves harvesting the cells on the patient’s first visit, growing them to larger numbers over approximately two weeks, testing the cells, then re-injecting the cells during the patient’s second visit. Dr Chris Centeno explains the FDA’s stance on the Regenexx-C cultured stem cell procedure, which has not been performed in the United States since 2010 (currently offered by Regenexx Caymen): [Disclaimer: The Regenexx™ same-day procedures are performed in the United States. The Regenexx-C cultured stem cell procedure is only offered outside the U.S. through independently owned and operated medical services providers operating exclusively in countries that allow autologous cultured cells to be used through their local regulatory structure. These service providers are not part of nor affiliated with the Centeno-Schultz Clinic nor any U.S. Regenexx Network provider. The Regenexx-C procedure licensed by these entities is not approved by the U.S. FDA for use in the United States.]
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[Disclaimer: The Regenexx™ same-day procedures are performed in the United States. The Regenexx-C cultured stem cell procedure is only offered outside the U.S. through independently owned and operated medical services providers operating exclusively in countries that allow autologous cultured cells to be used through their local regulatory structure. These service providers are not part of nor affiliated with the Centeno-Schultz Clinic nor any U.S. Regenexx Network provider. The Regenexx-C procedure licensed by these entities is not approved by the U.S. FDA for use in the United States.]

No. PRP is concentrating platelets in the blood, not stem cell therapy. This is a more detailed discussion on the differences between PRP and stem cell therapy. In addition, while PRP is one component of the therapy, we use a very different “Super Platelet Mix’ which we believe helps to produce many more stem cells.

We do offer the Regenexx-SCP procedure, which is a platelet procedure which is quite different from the bloody PRP available through commonly used bedside centrifuges. To see a patient infographic on these differences, see this link for general info on the Regenexx-SCP platelet procedure and this one for a comparison between SCP and bedside PRP machines.

No. The Regenexx procedure involves isolating stem cells in a state of the art lab that’s part of a medical practice. Unlike centrifuge machine procedures that produce a “one size fits all” solution, the Centeno-Schultz clinic in Colorado uses cell biologists to get to much higher stem cell numbers than are possible with a bedside machine. The network doctors who have learned these techniques also process their samples by hand in mini-labs.

In addition to peer reviewed publications, we also publish our treatment registry data online. See the most recent treatment registry data on Regenexx-SD for knee arthritis, hip arthritis analysis 1 and analysis 2 using different metrics, all shoulder patients, rotator cuff tear patients, ankle arthritis, and hand/wrist arthritis. In addition, low back sciatica outcomes on the Regenexx-PL-Disc procedure. Pre-publication data and before/after MRI case studies can often be found on the Regenexx blog.

No, they are simply your own adult stem cells. We only use autologous (your own) cells.

Cord stem cells are stem cells isolated from a baby’s umbilical cord. While they may be more biologically active because of their young age, recent research has suggested that they can also transmit genetic diseases that the baby may carry. Until these issues are further sorted out (likely with better genetic testing), We would advise against using any donor stem cells to treat non-life threatening disease. (cells from another person). This would include cord cells, embryonic stem cells, or someone else’s adult stem cells.

Yes,there are many types of adult stem cells. The most common is known as a hematopoetic stem cells (HSC-CD 34+). While these are easy to obtain from IV mobilized blood (where a special medicine is given to the patient first to push these cells out of the bone marrow) or bone marrow and are very plentiful. Outside of a handful of cardiac and vascular applications, they are not well studied as being effective in treating a broad range of diseases. Despite this, the vast majority of what you see being billed as “stem cells” from bone marrow (where the cells are injected the same day as collected) are these less useful cells. The type of adult stem cell that is most often seen in research as being associated with orthopedic tissue repair is a mesenchymal stem cell (MSC). MSCs can’t generally be harvested from blood. Fat tissue contains many MSCs, but these are distant cousins to the type obtained from bone marrow and aren’t as useful for orthopedic applications.

Yes. For orthopedic applications, two main types of MSCs have been used, bone marrow derived and adipose (fat) derived. Bone marrow MSCs are taken via a needle through a bone marrow aspirate. The bone marrow aspiration procedure sounds like a big deal, but we are consistently told by patients that the procedure is very comfortable. The second type of MSC is derived from fat tissue (adipose). This can be obtained via liposuction. For orthopedic applications, fat derived MSCs consistently and dramatically under perform bone marrow derived cells. In studies of cartilage repair, bone repair, and soft-tissue repair, bone marrow derived MSCs are much more adept at these tasks. This makes sense, as they perform this function naturally (homologous) everyday. For example, if you break a bone, it’s these bone marrow MSCs that help mend that bone. In addition, for surgical micro fracture to repair small amounts of knee cartilage damage, it’s bone marrow MSC’s that are released to do that job.

Yes and No. First, many adipose stem cell clinics dramatically over-estimate the number of stem cells in their processed fat. This is a good hard core science review of the kits often used by physicians which over estimate these numbers. Basically, what physicians believe to be cells are actually small globs of fat tissue. Second, the proprietary Regenexx stem cell isolation method dramatically increases the number of stem cells isolated from bone marrow (based on our lab studies).

Still, on a weight to weight basis, fat can contain more mesenchymal stem cells than bone marrow, but the problem is that they just don’t work as well for orthopedic applications (click here for more information on this topic). In addition, in the Regenexx-AD knee stem cell procedure we offer the best of both worlds, bone marrow and fat.