Last year I blogged a couple times about Dr. Christopher "the renegade" Centeno from Regenerative Sciences, Inc (aka "Regenexx"). He's in Colorado collecting, growing, and re-administering stem cells for now a growing list of orthopedic-related conditions.
As previously discussed on this blog, FDA CBER's Mary Malarkey sent a warning letter in July 2008 to Dr. Christopher J. Centeno, Medical Director of Regenerative Sciences, Inc (RSI), doing business as Regenexx. The company responded on its website that they do not fall under FDA jurisdiction. One of the reasons cited is that their entire procedure occurs within the state ergo no interstate commerce ergo no federal jurisdiction.
The good doctor (aka @stemcelldoc on Twitter) is not only rapidly expanding the indications for which he'll pump you up with stem cells, he is really ramping up his marketing. He is actively promoting his services on the internet (blogging, a Twitter stream, etc) encouraging people to come from all over god's green earth to visit Colorado and get shot up with a dose of their own stem cells.
Now I know that archaic legal paradigms weren't designed for this new-fangled world but according to a good ole fashioned sniff test many would say that smells a lot like interstate commerce to them.
This is not a critique of the Regenexx therapy, Dr. Centeno, or the company. I'm not saying the Regenexx therapy doesn't work. I'm betting it does. I'm not saying I wouldn't be tempted to go if I had joint problems. I likely would. I'm not saying what they're doing is wrong or even illegal - sometimes it takes a gutsy cowboy/girl or two to change the rules for good. BUT if the FDA lets this happen in Colorado it seems to me a slippery slope to letting all autologous cell therapies go unregulated. And I don't see that happening any time soon.
Rumor has it Regenexx is planning to open a new clinic in Florida. There's the slope in clear sight.
On other fronts, there have been reports of the Regenexx therapy being reimbursed by at least one insurer. Aside from the FDA, this is quickly gaining all the hallmarks of a legitimate medical procedure. As of November, they had performed 250 procedures.
In September last year Dr. Centeno posted on an online discussion board:, "To set the record straight, we have been working with regulatory council for 3 years on our needle based, surgical procedure. We have responded to the FDA unititled [sp]letter and we believe we have answered all of their questions. This is a surgical procedure and not a new biologic drug. We have been communicating with the FDA and they have had no response, so we assume that we have answered their questions."
The FDA may not have any more questions but unfortunately I doubt that ends the issue.
Interstate commerce aside, Regenexx appears to be manufacturing a biological therapeutic. While they appear to have taken references to cell expansion or manipulation off their website, according to a recent blogger allegedly quoting from a letter from the company, the stem cells are collected, expanded (at minimum) and reinjected. The letter apparently stated: "The procedure involves drawing our patient’s blood and bone marrow, growing their stem cells in our laboratory for approximately 3 weeks and then injecting the stem cells into the affected joint".
If this is true, it seems to me this is not just a doctor doing his doctor thing and the big, bad FDA should let a doc be a doc. This would be a doctor manufacturing a biologic without any of the manufacturing controls created by regulatory agencies and industry to keep such things safe - safe, for instance, from contamination.
If there are no such controls in place god only knows what kind of back-alley operations might come to town selling stem cells from basement labs. It is not far-fetched. If this is allowed to continue, other docs will get in this business. Some will decide they just want to run the clinic not grow the cells. They outsource that to company X which is being run by some half-baked science dropout who decided this is probly better money than making meth so let's start a stem cell grow-op! Ok, that's the extreme but you see my point.
I've got a lot of sympathy for people who push against the rules. I believe Dr. Centeno and his company are doing what they believe is right and I'm sure they are doing everything they can to ensure their product is safe and efficacious. I also believe that in years to come we may well be comfortable enough with these types of products that this may well be as commonplace as Dr. Centeno would have it but I don't think it will be in his lifetime. At least not in the US. I kinda hope I'm wrong.
We can't simply let the market decide which therapies will succeed. We need a minimum level of safety assurance and oversight by an agency like the FDA and without any controls how long is it before someone perhaps not as diligent or trained as Dr. Centeno makes a product that does more harm than good?
I think the FDA is building its case and a showdown is on it's way to Denver-town.