The FDA has yet to approve stem cell therapies for general use in medicine, but that hasnt stopped doctors in Colorado from providing them anyway. Chris Centeno and John Schultz have boldly formed Regenerative Sciences Inc. in Broomfield, Colorado. RSI provides its patients with the Regenexx procedure, an adult stem cell transplant that uses your own cells (autologous) to treat joint injuries and bone damage. Theres no surgery needed. A needle extracts bone marrow, RSI isolates the stem cells and cultures them in your own blood, and then these cells are injected into the area where they are needed. Theyve treated 348+ patients with 800+ injections and show no signs of slowing down. According to RSIs own surveys, 89% of their knee patients showed marked improvement, as did 75% of their hip patients! Within months some patients can walk or run in ways they havent been able to in years. Weve seen these kinds of results from stem cell treatments before, but only in horses and dogs. Thats because human stem cell therapies like this one arent approved by the FDA. How can Centeno and Schultz flaunt the lack of federal approval? They claim that Regenexx is solely used as a part of their medical practice, only within the state of Colorado, and as such is no more regulated by the FDA than it would be by the FAA or the Department of Motor Vehicles. I had a chance to talk with Dr. Centeno over the phone and learn more about Regenexx and RSI. For hundreds of patients, he and his team are providing a remarkable hope. Theyve brought lab-cultured medical stem cell therapies to the US. Finally.

Stem cells have been a focal point for hype and hope for years now. Besides healing horses and dogs, they have promising effects on diabetes, corneal blindness, even HIV. Its pretty clear that theyre also the future of organ transplants. Just the news of a stem cell related development or patent will cause a biotech companys stocks to soar. The FDA, which regulates all interstate drug sales and related clinical trials is not trying to keep Americans from these miraculous cures, its simply trying to make sure they are safe first. Apparently, thats taking too long. Medical tourism agencies are starting to cater to those seeking stem cell treatments. Whether or not they are ready for widespread medical use, stem cell therapies are in high demand, not just in the US but around the world. Its no longer a question of when we will have access to these treatments, its a question of how.

Patients interested in the Regenexx procedure face what seems to be a fairly standard experience for autologous stem cell transplants. It takes 20-40 minutes to extract the cells from hip bone marrow with limited anesthesia, and blood is also taken. Over a month RSIs lab will isolate mesenchymal (multipotent) adult stem cells and multiply them until they have 1 to 10 million. Typically, a patient will receive an injection into the treated area once a month for three months. Positive results are sometimes seen quickly (in 1 to 3 months) but will hopefully develop within 6 to 9 months. Importantly, theres no down time as a result of the procedure. Patients can leave the clinic and go home after each injection. A round of Regenexx (extraction, cultivation, and 3 injections) costs $7000-$8500. Those who produce exceptional numbers of stem cells can use subsequent injections (even in other parts of the body) for around $3500. Most insurances will not cover the treatment.

The fact that RSI isolates and cultures (multiplies) the cells is a big difference from other clinics that offer stem cell therapies. That process allows the lab to create enough mesenchymal stem cells to really have an effect on the area in which they are injected. Many clinics around the world will take blood, marrow, or tissue and then spin out the stem cells in a centrifuge, injecting them back in on the same day. That style of therapy could possibly be effective, but it is far less likely than with a dose of millions of multipotent stem cells. There are several doctors around the US that will provide such single-visit stem cell therapies, but as far as I know RSI is the only that offers the lab cultured mesenchymal therapy in the US. Dr. Centeno has confirmed that hes the only one, that he knows of, openly using this particular procedure in the US.

In the past, I have been very skeptical of stem cell treatment centers in other countries. Id like to turn that same critical eye to Regenexx. Its only fair. First, lets look at the success RSI is selling. Autologous transplants are offered in the hands, hips, knees, shoulders, back (non-spinal cord injury), ankles, and bone fractures. For each of these procedures you can find many ardent and exceptionally encouraging patient testimonials on their website, or their YouTube channel, along with a flood of supportive media. Heres a clip from a local news Channel which is pretty indicative of the rest:

Overall, RSI is claiming around 80% patient satisfaction according to its own surveys. Thats incredible, especially when you see some of their patients walking and running again on joints that have experienced years of chronic damage. It also seems Centeno and Schultz have the documented evidence to back up the claims for Regenexxs success. RSI provides case studies for each of its treatments as well as published scientific research. According to my conversation with Centeno, RSI is currently working on a comprehensive statistical analysis of their more popular treatments so they can publish quantitative results in a peer review journal. In other words, theyll soon publish the hard numbers X% of patients feel Y% better Z months after the procedure.

Importantly, RSI seems to be upfront with patients about the limits of their own technique. The website FAQ clearly states that not all results will be like the testimonials, and they even have a dedicated page explaining that stem cell therapies wont work for everyone. Furthermore, RSI has published the largest study of risks and complications associated with stem cell treatments yet produced in the US (N=227). That paper demonstrates the very low harm associated with stem cell therapies much lower than the alternative surgery(published in Current Stem Cell Research & Therapy). Centeno told me that if were really worried that autologous stem cell therapies are going to hurt someone, this paper pretty much shows they wont.

The concerns most people have with RSI are not medical, theyre political. Many applaud Centeno and Schultz for supplying the public with the cutting edge technology they demand, but worry about the manner in which it has been accomplished. Skirting FDA approval for a technique through the arguments they use opens the gate to a host of problems. If RSI can provide Regenexx because it is a doctors procedure not involved in interstate commerce, does that mean someone else can do the same for another treatment? What are the limits of such procedures? How does a patient know if a doctors therapy is safe, or effective, if it hasnt undergone peer review and government inspection?

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