Dr. Centeno is offering stem cell therapies for orthopedic damage with remarkable results. Is this the future of stem cells in the US?
The FDA has yet to approve stem cell therapies for general use in medicine, but that hasn’t 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. There’s 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. They’ve treated 348+ patients with 800+ injections and show no signs of slowing down. According to RSI’s 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 haven’t been able to in years. We’ve seen these kinds of results from stem cell treatments before, but only in horses and dogs. That’s because human stem cell therapies like this one aren’t 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. They’ve 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. It’s pretty clear that they’re also the future of organ transplants. Just the news of a stem cell related development or patent will cause a biotech company’s 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, it’s simply trying to make sure they are safe first. Apparently, that’s 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. It’s no longer a question of when we will have access to these treatments, it’s a question of how.
A severely damaged knee healed to a remarkable degree. Must be stem cells. RSI is offering adult stem cell therapies in the US. That's an important first, but what will happen without FDA approval?
Patient’s 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 RSI’s 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, there’s 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 he’s 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. I’d like to turn that same critical eye to Regenexx. It’s only fair. First, let’s 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. Here’s 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. That’s 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 Regenexx’s 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, they’ll 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 won’t 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 we’re really worried that autologous stem cell therapies are going to hurt someone, this paper pretty much shows they won’t.
The concerns most people have with RSI are not medical, they’re 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 doctor’s 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 doctor’s therapy is safe, or effective, if it hasn’t undergone peer review and government inspection?
During my conversation with Dr. Centeno, he pointed out that doctors and surgeons are developing new procedures all the time. Surgeons will often create new devices for their own use in surgery, doctors routinely try out new dosing regimes, or therapies on their patients. This is part of the medical profession.
Still, it’s possible that even though RSI is doing what many other doctors routinely do (develop a new therapy for use in their own practice) that the federal government could try to bring them to court. The FDA seems to have taken the stance that all stem cells (whether used autologously or not) are drugs. As such, they would need FDA approval, and would likely only be developed by large pharmaceutical companies.
According to Lee Buckler of Cell Therapy Blog, Centeno’s already received a warning letter from the FDA. Centeno clarified that this is actually an “untitled letter” which has no bearing on regulation. He pointed me to this explanation on untitled letters. RSI has faced concerns from the New York Department of Health, and went so far as to pursue a provisional license, even though they are no where near NY state. Clearly RSI is hoping to avoid bureaucratic problems or at least be very prepared for them if they do arise. Perhaps with enough positive results they can avoid legal battles and even convince insurance companies to cover Regenexx.
Hopefully so. Just look as these results. They’re pretty damn amazing. If you accept the success rates, and the possibilities for long term healing…I know people who need this. I really want them to be able to get it.
Centeno says he is working with others to provide the framework through which many more patients could receive mesenchymal stem cell therapies. He’s on the board of the International Cell Medicine Society (ICMS) which is working to track stem cell therapy patients through a registry, as well as certify stem cell clinics for practice. Through conferences and seminars, doctors are trained in IVF to work in fertility clinics. Centeno explained to me that a similar practice could instruct and track physicians interested in providing lab cultured autologous stem cell therapies. In other words, the technique used by RSI could become a regularly seen procedure in specialty clinics across the country. That may mean more patients could have access to stem cells soon.
One way or another, I know they will. FDA approval is slow, but it’s coming. Athersys has a patent for a stem cell derived drug, other companies have therapies in clinical trials. Those treatments will be here some day. In the meantime, RSI is filling in the gap. Their work may even catch on as a trend. If largely successful, insurance companies may pay for it and the federal government may end up grandfathering Regenexx in at some point. It could happen. What’s certain is that the public demand for stem cell therapies is real, growing, and seemingly justified. When that sort of pressure for a technology exists nobody can keep it down.
**Update: It has been pointed out that we have neglected to consider the long term effects of stem cell therapies. This is an oversight on our part, but the reality is that there is no conclusive understanding of what the long term effects of stem cells treatments will be. We do not know if a stem cell treatment will be effective 5-10 years after it is administered, and we know of no large study that has conclusively reviewed patients for cancer, or any long term side effect 5-10 years after a stem cell injection. I believe that part of what ICMS is trying to do (reviewing clinics, tracking patients results over the long term) may yield a better understanding in the future.**
[image credit: Denver Business Journal, Regenerative Science Inc]
[video credit: ABC 7 News in Denver via Regenexx (copyright status unknown)]
[Sources: Regenerative Sciences Inc, ABC 7 News in Denver, Lee Buckler , RSI Blog, Current Stem Cell Research & Therapy]
Tags: adult stem cells, autologous, broomfield, Chris Centeno, colorado, FDA, John Schultz, mesenchymal stem cells, multipotent stem cells, Regenerative Sciences Inc, Regenexx, RSI
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rageahol,
No, see posts below. Teratomas don't result from MSC's cultured for short durations. They are a frequent side effect of embryonic, cord, and fetal cells transplants, but not adult MSC re-implants. We have about 60 3.0T MRI's (the best imaging technology currently available) of the re-implants sites where our procedure was used to re-insert the patient's own cells. None of these have shown any evidence of a teratoma, which is consistent with the research of others in this area.
The safety data (well beyond phase I/II clinical trial requirements) is listed at http://www.ncbi.nlm.nih.gov/pubmed/19951252. N=224 with high field MRI monitoring of about 50 re-implant sites (read hundreds of serial MRI's) over 3 years. Working on several large efficiacy case series and will certainly get to larger blinded RCT's. Agree that everybody should be cautious about interpreting our outcome results as generalizable to larger populations until all the data is in.
Mr. Caldwell also discussed some of Advanced Cell Technology's other research programs, including its research into producing blood from embryonic stem cells, saying, “We can manufacture blood, and hopefully that will have all sorts of applications, including for the military… to address issues around the lack of blood for soldiers out in the field.” He also discussed the company's Myoblast program for the treatment of heart failure.
Mr. Caldwell commented on the overall stem cell industry, saying, “It's an exciting field and it needs a little bit of a kick-start. That's why we believe our initial indication will help validate the industry, because it's what we believe to be low-hanging fruit.”
http://tinyurl.com/yfptwr2
Have you researched the Centeno firm? I contacted them about my shoulder (no glenoid due to prior surgery) and the up front fees were quite substantial. To the point, that I did not follow up. Further, I was not able to obtain any referral information from clients that had successful stem cell therapy for my type injury. My initial thought was that this is a bit of a scam, though I really don't know.
I not only researched Dr. Centeno’s procedure, I had it and although only enough stem cells were harvested for one shot instead of the four generally given, the difference has been miraculous. It has been two years and I am still seeing improvement and I believe had I had the four shots, it would now be about perfect. And, just for the record, surgery for my condition would have been upwards of half a million, so I thought a few thousand dollars was worth the risk and if it helped me, it maybe would help others. I was a month away from assisted living and in unbearable pain. That was two years ago and I’m still working and living independently thanks to this treatment. My orthopedic doctor was very skeptical of the treatment and I went back to see him after treatment and asked him to X-ray me so he could see the improvement and he told me he didn’t need to do X-rays, that he could see the huge improvement. I would have this treatment again in a heartbeat if I needed it. And, for the record, Dr. Centeno was very cautious about doing the treatment on me because he was not sure if it would succeed or not. I said I had to try and convinced him to go ahead. Also for the record, as I sometimes get calls from people, my video on the website is real and it was not scripted.
Jack,
I can assure you we are no “scam”. We do require that the patient get on the phone with us with his/her films so we can tell patients (before they spend the money to travel to see us) if they are GOOD, FAIR, POOR candidates for the procedure. We can't help everybody and are very upfront about that, so it's entirely likely that if you had no glenoid fossa left from a prior radical surgery, we felt it wasn't worth you pursuing this type of treatment further. We do routinely provide former patients for our prospective patients to contact, but again, due to your unique pathology we may not have had a patient with this type of severe shoulder issue that had been treated.
Our procedure is not covered by insurance at this point, so there are definitely out of pocket costs.
Chris Centeno, M.D.
Awesome. Where are the ICMS data made available for public inspection?
[...] Exclusive: Doctors Skirt FDA To Provide Human Stem Cell Therapy | Singularity Hub [...]
The fact that big pharmaceuticals are buying up stem cell treatment companies is proof enough they are trying to snuff out the competition. What this will mean though for Americans is that many more will die waiting for the FDA to get with the program of curing diseases -not prolonging them. I applaude Dr. Centeno for taking the stand, and for actually benefiting human health not for making billions of dollars of profits for “making claims” to cure diseases with carcinogens. Wake up and smell the ether…the medical establishment is either going to cure diseases or another country will and the US will be left to the corrupt system in place right now. Enough is enough…people are sick and tired of this corrupt system of profits before the health of people.
The argument that big pharma is buying treatment companies isn't convincing; many startups are designed and structured such that a buyout by a larger company is the goal. It isn't a case of buying up the competition so much as making sure the founders of the startup get a chance to cash in.
I'm asking for independent verification – data – that this particular practice is advancing human health. Still waiting for it. One or ideally more than one piece of evidence that RSI is improving human health, not generated by someone with a financial interest in the practice. I'm not saying it isn't there, just unable to find it on my own. And until I see it, I'll remain skeptical – something that I'd encourage every reader of this post to do as well, as a general rule about any such claims.
Skepticism is good for stem cell therapeutics, not bad for the field; by demanding rigorous standards of proof, we force practitioners to improve their products. Ultimately, this benefits everyone.
So, let's see it.
check out repairstemcells.org (don margolis)
[...] Exclusive: Doctors Skirt FDA To Provide Human Stem Cell Therapy | Singularity Hub [...]
[...] Human stem cell therapies like this one aren’t approved by the FDA. (Source: http://singularityhub.com/2010/03/09/colorado-doctors-skirt-fda-jurisdiction-to-provide-human-stem-c...) [...]
I'm a big believer in stem cell research and that it should be allowed. People with chronic and genetic diseases believe that stem cell research is their only hope for finding a cure. The government should be more open minded toward doctors and surgeons developing new procedures.
Dr. Centeno,
I have just read about this today, and I wanted to applaud your efforts. I think that even if your practice turns out to be unsuccessful, you are taking medicine in the right direction by attempting this. I have always been in support of stem cell research, although admittedly I know very little about the subject. I think given enough time and research in the area, mankind could one day use it to cure almost anything. Or at least I hope so anyway. The current success seems amazing.
I can say that if I ever develop any problems that could potentially be corrected by this procedure, then I will strongly consider coming to Regenexx. I will be keeping an eye on this to see how it progresses.
I appreciate that you take the time to discuss the details with everyone here. Keep up the good work, and best of luck to you in your endeavors!
[...] sans FDA approval, because they don’t need it for what they’re doing – are helping people avoid surgery and drastically improving their lives right now. And they don’t have to kill a single baby [...]
Personally I am rather pleased that someone has shown the testicular fortitude to put this sort of therapy out on the market.
Finally we will get a chance to see how stem cell therapy holds up in the long term. Good move tracking the patients, in 20 years time we'll start to get an idea of things like long term effectiveness of the treatments along with the rates of any diseases or conditions they develop. Might shut up the “it'll cause cancer!” crowd.
Excellent article. I always enjoy what you guys at Singularity Hub find. After reading this I did a web search and found two other US based outfits (Florida and North Carolina) that appear to be doing a stem cell implantation for orthopedic issues although it seems that they are not incubating the cells for ~20-30days like Regenexx. They also might be worth a look or having an additional article about. 1) Dr Alan Lazar (dralanlazar.com) and 2) Insitute of Regenerative and Molecular Orthopedics (stemcellorthopedic.com)
Let's hope this stem cell biological knee replacement works! Sounds very much like the work of Dr. Stone and the Stone Clinic in San Francisco.
I believe Dr. Lazar and Purita do BMAC injections, a much simplified procedure where a simple bedside centrifuge concentrates bone marrow cells. There's some question of whether this produces enough stem cells to be effective, see http://www.regenexx.com/2009/02/bone-marrow-nuc...
Yes I think they do BMAC. I think the jury is still out on which performs better. I beleive X-cell in Germany also does not incubate the cells for more than a few days.
[...] Doctors Skirt FDA To Provide Human Stem Cell Therapy [...]
I'm not a doctor, neither a surgeon or a researcher but I work or worked closely with some Orthopedic Cie in USA and Europe, which are most of them privately founded by doctor and researcher (meaning not these big corporation some of you are talking about in their post).
I can testify in good faith that there are HUGE problems in USA when it is question to bring innovative solution to American citizens.
The first one is related to the US healthcare system that doesn't cap the price in the medical and pharmaceutical industry. I'm amaze almost every time to learn that the same exact implant or technology can be sometimes (most of the time?) 10 times more expensive than the exact same one in Europe (a $300 orthopedic screw in Europe becoming $3000 by magic in the US).
No wonder the US government cannot offer a 100% coverage for US citizen medical bills like it is the case all over Europe. The only explanation I can found is that the lobbying of the pharma. and medical related big corporation is very strong. Too strong and should be fight.
On the other side, FDA seems to be a HUGE break to innovation in the US and seems to work and decide with no apparent logic. And when you take a step back to look at the big picture they definitively seems to play the game of the big corporation. Even if you believe in coincidence, you would have a hard time to swallow it.
The results are unfortunately simple and dramatic :
- Many Americans don't have access to innovative treatment that are most of the time already available in Europe for years,
- When they do have access, these innovation are usually sold by the big corporation (who generally bought the innovation from little start-up which strangely never got approved by the FDA – or was requested a multi millions dollars clinical study – that put them on their knees and obliged to sold themselves to the devil.
- Of course, insurance who are here for profits – by opposition of a general healthcare system like in Europe – are not covering the bills. I Cannot really blame them for that. You will not pay $150 a steak coming from the same cow if you know you can have for $15 next door. But at the end, a lot of American suffer and dies because they cannot afford a treatment that is almost free in Europe !
I'm not saying the FDA should disappeared, but my point of view is that this institution is not fair and showed many time that it is not qualified for the job they have to do. It should be reformed from the Ground.
I invite you to question yourself about what you want: If it is to have access to a treatment when they need it without asking how much it will cost, you should definitively write a letter to cap the price of pharma and medical products on one side and ask them to reform the FDA to remove the worms inside the apple.
If you are still reading my comment, you will not be surprised that I can only applause Dr. Centeno, his partners and team for their stand.
If they're practicing medicine why are they not following the standard rules of medicine?
Stem cells on a good day are unpredictable, and are far too complex to simple be injected into a place and just 'work'. Life doesn't happen that way.
If you don't believe me that's fine. This website is the only source I know picking up the story as original. If you see this miracle cure in 5 years, I'll eat my words. Otherwise I suggest you don't leap before you look in future scientific endeavors
Dear Chris,
You are correct with how stem cells replicate in our body every day. I right now have several of them migrating down a bundle of cells in my brain to my olfactory bulb. It takes these guys 21 days to make the journey, and they go through a lot of changes along the way.
As for car crashes, yes the body does an amazing job of healing it. However this is where your analogy and the science (at least explained via the article, please correct the author if needed) is different. You take stem cells from the body and cause them to replicate in large numbers. That is where car crashes and your treatment differ. One involves a lot less copying in an environment that is tuned to stimulate differentiation. The other attempts to mimic the environment and humans are simply not that adept yet. So ultimately your procedure will cause the original cells to replicate more than the alternative. These cells are then being put back into the body. So could cells get past your screening procedures? Yes… yes they can. Unless you fully sequence it, you can at best look for trends and oddities in the cells but that's it. We lack the tools right now to determine that these cells are not without potentially dangerous errors. I am not dismissing your work, but it doesn't follow the rules we have set out when performing medicine. You are skipping steps and that's dangerous. The FDA doesn't like to write warning letters to people for fun after-all. I've done some quick searches and have yet to find a peer reviewed journal with anything published by you Chris. I must say you have done an excellent marketing job for yourself and your work but that doesn't allow you to bypass the moral and ethical obligations you swore an oath to when you became a doctor.
Sincerely,
Billy
The FDA may prevent some discomfort or in rare cases death for a few people from bad side effects of new treatments, but how many MORE people suffer or die because the treatments aren't allowed to be available when they need them.
Even without the FDA drug companies can and do go through extensive testing of new drugs for efficacy and safety in order to avoid lawsuits. The FDA does it's best and the people who work there really do try but ultimately it's an counter-productive government bureaucracy and we should find something better for those employed there to do.
Paul,
> I’m amaze almost every time to learn that
> the same exact implant or technology can
> be sometimes (most of the time?) 10
That is because the U.S. taxpayer subsidizes the rest of the whole freaking world that implement price controls on U.S. invented medical drugs and devices!!! There is no free lunch in economics; someone ultimately has to pay the costs. Non-U.S. citizens get a free ride off the backs of U.S. taxpayers, not just in overregulated medical drugs and devices, but also in lightly regulated dietary supplements.
> On the other side, FDA seems to be a
> HUGE break to innovation in the US and
> seems to work and decide with no
> apparent logic. And when you take a step
No argument here. The historical facts and evidence is damning. The FDA needs to be abolished or majorly reformed. It is simply beyond corrupt with agricultural and drug industry, revolving door, unelected bureaucrats.
[...] Exclusive: Doctors Skirt FDA To Provide Human Stem Cell Therapy [...]
[...] is something very engrossing about the idea of having your body provide its own cure for a disease. Autologous stem cell treatments may enjoy some increase in their popularity due to a similar perception. In the future, we may be [...]
[...] heavy (and slow moving) regulation of the US and Europe, though a few (such as XCell in Germany and Regenexx in Colorado) operate within them. Essentially this means that most stem cell therapies a patient could receive [...]