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Exclusive: Doctors Skirt FDA To Provide Human Stem Cell Therapy

regenexx stem cell therapy from Centeno

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.

regenexx stem cell knee therapy

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]

[Sources: Regenerative Sciences Inc, ABC 7 News in Denver, Lee Buckler , RSI Blog, Current Stem Cell Research & Therapy]


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90 comments

  • elvenrunelord says:

    We have waited for years for this technology to move forward and political cavemen have prevented the advances that will benefit all of us.

    Bravo to these doctors for working around a system that seems to protect big corporate profits more than it provides for the needs and wants of consumers.

  • centenooffice says:

    Aaron,

    Thanks for the coverage of an interesting issue. I would like to echo that ICMS (mentioned above) is a professional society that has produced strict clinical and lab guidelines for autologous stem cell use and has begun a third party non-profit tracking registry to follow-up on outcomes and complications.

    We are at about 450 patients and about 900 procedures and will submit for publication an additional (larger) complications tracking update (n= approx 400) as well as several large outcome case series this year. What we do is not a panacea, and I think you point out nicely that we don't make that claim, our procedure has its successes and failures like any other medical procedure. We are proud that we have safely help many patients avoid or delay much more invasive surgeries as part of medical practice here in Colorado.

    It's important to note that have not attempted to “skirt” anything. We began this journey in 2005/2006 with multiple legal opinions about what was the practice of medicine and what was drug production. If IVF (invitro-fertilization) were developed today with its 100x culture expansion of human embryonic stem cells (otherwise known as a blastocyst), I'm sure FDA would lay claim to it as the production of a biologic drug that needs to be regulated on a federal level. Many, many OB/GYN fertility specialists would ardently disagree that this is the case, stating that IVF is a medical procedure. IVF is not FDA regulated at this point and my OB/GYN colleagues have produced their own clinical and lab guidelines and partnered with various national organizations (for independent third party credentialing and outcome tracking). We have done the same. We are working at the highest levels of government now to help FDA clarify its own rules so that it can better differentiate the practice of medicine from biologic drug production (i.e. products and devices sold at the federal level in interstate commerce).

    Chris Centeno, M.D.

  • adsaenz says:

    Thank you Dr. Centeno for clarifying and weighing in on the article. I think most readers are going to be excited and thrilled about the work you and your colleagues are performing in Broomfield. I hope that Regenexx (and similar procedures) become as numerous in the US as IVF and with the same support/acceptance from all vested institutions (government or otherwise). I wish you and RSI the best of luck in the future.

  • Billy Smyth says:

    I'm sorry but this article is not cool. The idea is promising, but all the good is being spun with none of the bad. Big issue that is KNOWN AND COMMON with the technique they are using (taking a small stem cell sample and growing larger quantities) is that cancer rates traditionally increase in these patients. It is very common for a bone marrow recipient to have lymphoma afterwards due to the proliferation of the stem cells. Each time the cells copy, even stem cells, mistakes can be made. This treatment is no exception.

    I expect these doctors to be arrested as what they are effectively doing is conducting a clinical trial with the purpose of making profit.

  • Frank says:

    This has nothing to do with fetal stem cell research. Even fetal stem cell research wasn't banned by 'political cavemen', just federal funding for it.

    Regardless, I doubt this is for real.

  • ABowling says:

    The “political cavemen” you describe are not PREVENTING advances that WILL benefit ALL of us. They are treading carefully when setting regulatory precedent for therapies that HAVE THE POTENTIAL to change the way we treat millions of patients. Although the FDA may move slowly, it does so with purpose – promoting safety and efficacy. While this may prevent the implementation of these therapies for several years (typical clinical trials are 14 years), their methodology prevents a high majority of widespread mishaps due to the early implementation of a therapy with unforeseen side effects.

    • Mark2011 says:

      You like when pfizer passed their drug CELEBREX???? The drug that passed FDA approval and then KILLED dozens of people who were taking the drug for arthritis!!!!!

      LOL All these drugs are flawed and us poor people using them have no way to prove their side effects!! Even when they advertised the drug on TV do you listen to how many crazy side effects every single drug has??? It’s insane!! And so is the FDA and the pharmaceutical companies producing them!!!

      I would never take any of those drugs no matter what my illness!! Diet, exercise and eat healthy will cure most illnesses and then helpful processes like this one is just the beginning of a generation of natural healing remedies and a true breakthrough in science and medacine!!!. FINALLY!!!

  • Ian Goodacre says:

    I suspect what is most likely to stop RSI is neither medical nor political, but economic concerns. The potential benefit and willingness to pay for therapies based on stem cells is enormous. There are large corporate interests attempting to capture that benefit and I expect some will use every means available to them to prevent competition, including applying extreme pressure on the FDA and other regulators.

  • centenooffice says:

    Billy,

    I appreciate your viewpoint, but wanted to point out some inaccuracies. The totality of the existing data would not agree that taking stem cells from a patient and multiplying them causes cancer, in fact many publications would argue the opposite. I think there may be some misunderstanding on what I think is being discussed in your post, bone marrow transplants in cancer patients. Right now, bone marrow transplants are generally not culture expanded, but simply saved in cryo-preservation and then re-implanted in the same patient (or transplanted into another patient).

    Adult stem cells replicate in our body every day. As another example, if a patient breaks several bones in a big car crash, the local marrow mesenchymal stem cells seep into the fracture site and form a clot. They along with other cells then proliferate and grow into the matrix to form new bone and heal the fracture. The stem cells used to heal the broken bone are not then gone from the body forever, but immediately replaced through the body's own culture system in the bone marrow. The same happens when a surgeon performs a micro fracture procedure in a knee to try and heal a hole in the cartilage, the stem cells seep into the lesion and then are replaced by the body. Your body does this everyday to stay alive and healthy, i.e. stem cells are used to repair traumatized tissues (read a heavy work-out at the gym), and they are replaced through culturing in the body (your body grows more). If this didn't happen, you would quickly deplete your body's supply of stem cells and age at a greatly accelerated pace.

    In particular, we add an extra safety step to our procedure which is performed by the University of Colorado Genetics lab. These experts analyze the cells grown to rule out any clonal genetic abnormalities in the cells (the issue you bring up). We have strict release criteria, that are frankly likely unnecessary given the data published by our group and others, but we believe on erring on the side of caution since this is a new procedure.

    Chris Centeno, M.D.

  • mycophage says:

    I feel like skepticism is warranted here, as in all cases of extraordinary claims, and it makes me nervous that the main source on this is Centeno, who at the very least has a financial incentive to claim that his treatments are safe and efficacious.

    Is there an independent source (specifically, one that is financially independent from RSI) that has evaluated the outcomes of these treatments?

    Right now the “case studies” and “published research” links are giving database errors, so it's hard to tell what they contain.

  • robot_makes_music says:

    We are being played for fools.

    “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.”

    And the FDA is run by ex-industry leaders. Stem cells are amazingly effective and frighteningly cheap when compared to the modern pharmaceutical industry's methods of “cure.” If these are not locked up, they will do to the pharmaceutical industry what Napster did to the music selling industry.

  • Anthony Musci, M.D. says:

    Is the blogger here a scientist or a cheerleader? Testimonials? Supportive media? Are you kidding? The problem here is not political but absolutely MEDICAL. Absent a compelling controlled clinical human experiment, the sale of this technique is just more snake oil.

  • ABowling says:

    They aren't being regulated strictly as drugs. That's just not true. You obviously aren't familiar with the industry, the regulations, nor the science. Depending on the extraction, manipulation, and re-insertion techniques involved; these can be regulated as drugs, biologics, or even medical devices.

    In addition, its incredibly foolish to think that the FDA would bar a therapy because its cheap and effective. That is their exact mission statement – and history would prove your statement wrong in thousands of instances.

  • centenooffice says:

    Like the past 10 years seeing “approved” drug after drug pulled from the market for being unsafe proves that the FDA process is what? That “history would prove your statement wrong in thousands of instances…”

  • robot_makes_music says:

    I think you just proved me right about the American populace being played for fools. Thank you for playing.

  • ABowling says:

    Although there have been drugs which have been pulled from the market (by the FDA mind you) – this would only suggest that the process is not robust enough – and further research is required prior to release of product into the market.

    If you're suggesting that the failure of several drugs over the past 10 years justifies bypassing the FDA regulatory system – well… good luck with your company.

  • ABowling says:

    Right. Its all a conspiracy. Watch out!

  • D Aiken says:

    Dr Musci, I wonder what your priorities are? What do you care about more? Patients or process? I believe that Vioxx and a host of other deadly drugs drugs came from your cherished clinical trial programs. If what Dr Centeno is doing is helping patients, why dont you learn mre about it rather than rushing to judgment and damnation.

  • adsaenz says:

    @mycophage,
    It looks like the entire Regenexx site is either down or slowed for the moment. Perhaps due to traffic from this post? I've double checked the URLs for the links, they are correct. Please try again after traffic has died down.

  • barbarahansonstemcellpioneers says:

    Weighing in as a patient I am thoroughly disheartened in this country by the lack of knowledge of so many people who do not realize that millions of people are dying while the FDA tries to figure out how to involve Big Pharma in stem cell therapy. I do not believe the FDA is worried about my safety whatsoever. The agency at one time might have had that function, but that has been lost in a mire of corruptness, conflicts of interest and a loss of scientific knowledge within the agency over the last few years. I want to be able to make the decision to have stem cell therapy with my doctor, not with a regulatory agency. I applaud Dr. Centeno and the ICMS for bringing that choice one step closer to reality. The U.S. is losing out economically as thousands and thousands of patients utilize offshore clinics. If that were not enough, the FDA cannot explain why fertility clinics are allowed to do what they do and yet they want to regulate our own stem cells in a different manner. There are NO stem cell based clinical trials for my disease in the U.S. Current medications become ineffective over time. The next step is looking at the grass from the other side for millions of us. To see comments from some that would deny us a chance to try stem cell therapy and insist their reasoning is for our own good sickens me. I am disgusted by it and I can assure you that if you were in my shoes, you would not be cheer leading the FDA's effectiveness nor claiming that stem cell therapy is snake oil when the scientific data proves otherwise. I urge you to support a system like ICMS has proposed and to get your own doctors involved as well. You never know when an illness may suddenly change your whole world. You would want to be afforded the chance to choose treatments that you want. I appreciate what Dr. Centeno and others are doing. They are true heroes for many of us.

  • Hal Kaye says:

    I will make this brief. This procedure works, I am the one in the YouTube story from Channel 7 that is part of the aritcle. Prior to having the procedure done, I was in pain 24/7, could hardly walk without a cane and only a few weeks from an ankle fusion due to the pain.

    I was lucky to hear about Regenexx and the procedure has allowed me to regain a positive quality of life that certainly would not have gone with an ankle fusion. I regularly excercise on a treadmill with a combination of jogging and walking between 2 and 3 miles 4 to 5 times a week. I play golf pain free and can walk around towns when on vacation. It does work, it is for real and my only regrets are that it is not available to more people before they go thru orthopedic surgery.

  • iamfromit says:

    I do like hearing from all of the viewpoints, but why not talk about the specific differences and the ethical confusion of the sources of useful stem cells? Not to throw gas on the fire, but there are more aspects to why it's okay to treat people with their own cells. That is the basis of the whole organic food movement. If it came from the natural ground, it must be healthy. If my body grew it, it must also be just as healthy.

    For instance, umbilical cord blood has large counts of hematopoetic ( which are typically pluripotent, from what I understand ). Has this therapy been used on any persons with degenerative bone/joint disorders in your practice, Dr. Centeno? Understandably, the percentage of persons with banked cord blood available so that these stem cells can be collected or derived from is severely limiting the available patient pool for this type of obersvation.

    Re: Dr Centeno's claim that the U of Colorado analyzes the generated cellular growth, it should be quite clear that they analyze a statistical sampling. There can be errors in any individual cell that then cause abnormalities which were not found. There is always a level of risk involved with large numbers of tiny things such as this.

    Re: Billy Smyth's comment about increasing cancer risk / occurence, it is a statistical matter. Deriving a single cell into 2, and then exponentially magnifying the chances of a differentiation disorder occuring in any of those cell divisions is significant when producing cells in this manner, as you've pointed out. Along the same lines, do you routinely take a different route to work to avoid being t-boned in the same intersection every morning? The statistical risk seems similar, on a seemingly less significant scale. It seems that if my body produced a significant sample, of say 1000 stem cells, with a 20% attrition rate during the cell generation phase of Dr. Centeno's treatment cycle, it would take 25 division/growth cycles to reach well over 100million cells. To get to that 100million+cells, it will take over 100million* cell divisions. ( * my math may be imperfect, so I'm lowballing that number on purpose ) It seems quite probable that some type of mutation may occur in the 100million divisions. Doesn't this occur naturally in our bodies every day?

    Statistically, most bodies seem able to defend against the typical mutations during typical cell division. At the least, it is certainly not accurate to say that therapies such as this are causing cancer of any form.

    I do agree we should be skeptical, but that is the only way of improving the process. 2nd guessing ourselves and re-iterating through the solution to the problem will eventually yield a more efficient and reliable process.

  • centenooffice says:

    Not all suggesting that the FDA process be bypassed by makers of drugs and devices seeking to be distributed across the country. We need “robust” safety systems in place for all products which can be shipped in vials or distributed en masse and may potentially make millions of people ill. The FDA is I'm sure made up of hard working scientists doing their best. However, the delivery of medical care, hospital care, and pharmacy items that are compounded are not part of a federal en masse delivery system, they represent one on one care scenarios with one on one risks. As an example, a hospital aquired complication from a surgery can be a serious to the affected patient, but it's not a national public health issue to be regulated by the federal government.

  • Franklin David Marks says:

    You can't possibly be so naive. The FDA is a criminal organization that by its own admission, in testimony to Congress, admits it does not have the wherewithall in knowledge let alone resources, to do its job. The FDA should be disbanded as fast as humanly possible with most of its so-called “agents” and executives brought up on charges for the suffering and pain they have caused millions through their heavy-handed tactics, idiocy and general slowing down of medical progress.

  • centenooffice says:

    We only use autologous cells, so I can't comment on the use of cord cells. There may be others more qualified in that field.

    Agree that healthly skepticism should be applied to this procedurem all drugs, surgeries, medical therapies etc… Every patient needs to weigh the evidence, the risks, and benefits of whatever they chose.

    We will publish as we go, as is expected of a credible medical procedure. Stem cells reproduce in our bodies everyday. There is no way to gauruntee that any medical procedure, drug, surgery is risk free, but I can say that after publishing on a dataset of 227 patients, in the period of time we looked (3 months to 3 years), our procedure had far fewer risks than more invasive the surgeries it helped many patients avoid. The correct link to the National Library of Medicine on that study is: http://www.ncbi.nlm.nih.gov/pubmed/19951252

    As I think the author alluded to, we grade every patient prospectively, only giving 1 in 4 patients we speak to a “good” candidacy rating.

  • rageahol says:

    so you advise your patients that similar procedures in mice frequently result in teratomas?

  • Keith Kleiner says:

    Procedures in mice have been shown to result in teratomas, but AFAIK most of those involve embryonic stem cells and those procedures are not the same as the autologous, mesenchymal procedure described here. Although the long term teratoma risk will only truly be proven or disproven once patients have been monitored over the next few decades, the evidence is strong that for Dr. Centeno's patients and for dogs and horses that the short term (1 to 3 years) teratoma risk is small. Many patients are willing to undergo this procedure now because they cannot wait 10 or more years to see how the long term risks play out. These patients should be allowed to make the choice to undergo this procedure if they don't have the ability or desire to wait.

  • OCBandit says:

    Billy,

    I think you might be on the wrong blog. The site for unsubstantiated claims made without references is at FoxNews.com.

    I expect these doctors to be seen as pioneers in both science and business.

  • OCBandit says:

    It was also published on /.
    Nothing against the number of users on this blog, but certainly there is a /. effect.

  • OCBandit says:

    Come on now, this is potentially game changing technology. The wonderful makers of drugs like Vioxx, Baycol, Meridia, Phen-phen etc. etc. are not going to sit back on this, but to suggest this is a drug or biologic is over-the-top. These are autologous cells. If you replaced a scab that fell off your body while healing, you have administered a biologic to yourself.

    In the end, demand will be too great and we the people will demand it.

    The FDA does not insert itself between the physician and his/her practice of medicine. I actually spoke to someone from the FDA Center for Radiological Health specifically about ad hoc surgical devices and the answer was clear. Physician are free to deliver care by way of their license to practice medicine and the FDA is not a medical licensing body therefore they have ZERO influence on how a physician practices.

  • christophernachand says:

    I, too, am a patient and cannot speak highly enough of this treatment. I have AO in both knees, and had reached the point with pain in my right knee that I could no longer run. I had previously been through physical therapy and pain medication injections with limited, short-term relief. I have been through three different procedures with Dr. Centeno and added 25% thickness to damaged cartilage, repaired torn meniscus on two sides, and filled in crevasses under my knee cap. I am now training to run a marathon with very little discomfort in the knee. I couldn't be much happier with the results and would recommend the procedure to anyone looking for a minimally invasive and effective treatment option.

  • OCBandit says:

    Second that comment from D Aiken and I would add…look at the existing stem cell research. Educate yourself and you'll notice something missing from equine, human, and canine research findings: significant side effects.

  • OCBandit says:

    RE: Dr Centeno's claim that the U of Colorado analyzes the generated cellular growth, it should be quite clear that they analyze a statistical sampling. There can be errors in any individual cell that then cause abnormalities which were not found. There is always a level of risk involved with large numbers of tiny things such as this.

    Would you have pathologists make the same claim, after all they are not looking at EVERY cell when they diagnosis a cancer. In the example of a breast biopsy it is a sample of a sample. However, in this procedure, it seems they are sampling the entire lot. Also you don't know their methodology and until you do, how can you comment with certainty.

  • centenooffice says:

    I think some clarification is in order. MSC's, unlike other stem cells, do not grow forever in culture. They are conatct inhibited by their nature, so most patients will “peter out” in culture around 2-3 weeks (just stop growing). This quite different from embryonic cells, fetal tissue, cord cells, and IPS cells that will “immortilize”, i.e. not show appropriate telomere shortening. Even when MSC's were recently placed in a medium used to immortilize cells and tortured by being “whipped” to grow well beyond their normal life cycle, while they will pick up genetic changes, they don't form tumors. For some references see http://www.ncbi.nlm.nih.gov/pubmed/17909019.
    In addition, research has shown that even if an MSC did become a problem in culture, the normal immune system takes these cells out of action (see http://www.ncbi.nlm.nih.gov/pubmed/20199238). This may explain that even when you torture cells and try to get genetic abnormalities, your left with cells that have no repair function, but don't form tumors.

  • donmargolis says:

    Wonderful article, interesting, colorfully written, and 95% accurate. Aaron, you are to be congratulated. Just one little thing—the FDA has never, in your lifetime (assuming you are under 35) cared a whit about safety. It is owned and operated by Big Medicine which is deathly afraid of what stem cells will do to profits. Dr. Centeno is not a threat because Big Medicine doesn't make very much on knees and hips. But you won't see any stem cell therapies in your lifetime curing heart patients, cancer victims, or diabetics, even though in the undeveloped world, these patients' lives are being improved with stem cells.
    Finally, pity people like Billy Smyth, who, like most Americans, has been horribly misinformed by his overly-trusted media. What you will never read in the NY Times, Billy is the truth, i.e. that EMBRYONIC stem cells cause cancer and has slaughtered thousands and thousands of lab animals. Adult stem cells cause cancer only in Big Medicine's propaganda machine and NEVER in human beings. Never, Billy, Never!

  • drpeter says:

    Where is the controlled randomized trial? Until then, I remain cautious. The potential to help and heal always carries the potential to harm. That is true of every treatment.

    Until then, this is unproven, both in safety and efficacy.

  • Keith Kleiner says:

    Of course you don't want the procedure because you don't suffer from knees that don't let you walk anymore. If you were in that situation, you might find yourself a bit more willing to take a chance on this. I think we are all cautious about it. Certainly it is not proven by decade plus results or a randomized trial…but that is besides the point. The point is that the therapy is promising, and although it might not be something you would want to do, other people should have the right to undergo the procedure if they feel it is right for them. This is especially true in the case where they are severely handicapped and this therapy represents their only hope.

  • goinveg says:

    “Skirt” my foot! RSI are not “introducing a drug into interstate commerce.” They are not even producing a drug for sale. They are taking a patient's own stem cells, culturing them and injecting them back into the patient.

    Athersys is creating a product for sale with these stem cells.

  • Zonsb says:

    So glad to see someone acknowledge that government officials aren't Superior in ability than other people. That what they have is a monopoly on the initiation of force, threat of force and fraud. I do not consent. To force or threaten force against my consent is enticement into involuntary servitude.
    That alone means they have less integrity than us innocent men and women.
    No pharmaceutical company officer ever goes to prison when people die or are injured from a drug approved by the FDA. No one at the FDA goes to prison for their gross negligence. For big Pharma the billions of dollars in fines they pay for injuring people is just a cost of doing business.
    There have been some drugs that have benefited many people. But the way the Pharma companies push drugs now you'd think a hundred years ago when their drugs weren't available everyone back then would have been dropping dead for lack of drugs.

    Why are there so many more ailments today than 100 years ago? Remember that the first letter in FDA stands for food. What a frikkin scam and fraud.

  • Zonsb says:

    Your sensationalism in attempt to minimize is revealing. It's not all conspiracy. There is a ton of fraud and criminality occurring by the FDA to pharmaceutical companies.

  • mease says:

    Billy,

    Are you wearing a foil hat? These doctors are practicing medicine! LOL

  • mease says:

    RSI participates with ICMS, a 501c3 non-profit that tracks it's complications and outcome through a third party treatment registry (similar to a bone marrow transplant registry).

  • mease says:

    Tony,

    I've read that about 1/2 of what our doctors do everyday has no such “controlled clinical human experiment”. Does that mean that half of what you do everyday in practice is “snake oil”?

  • centenooffice says:

    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.

  • centenooffice says:

    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.

  • wheresthefreemarket says:

    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

  • Jack Witkin says:

    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.

    • Sharon Lloyd says:

      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.

  • centenooffice says:

    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.

  • mycophage says:

    Awesome. Where are the ICMS data made available for public inspection?

  • Teriss says:

    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.

  • mycophage says:

    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.

  • mikesopm says:

    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.

  • Matt says:

    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!

  • BORK says:

    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.

  • NF says:

    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)

  • Dr. Douglas S. Shearer says:

    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.

  • GFR123 says:

    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

    • NF says:

      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.

  • Paul says:

    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.

  • Billy Smyth says:

    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

  • Billy Smyth says:

    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

  • orb says:

    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.

  • MachineGhost says:

    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.

  • MachineGhost says:

    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.

  • NF says:

    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.

  • NF says:

    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.

  • dan fahy says:

    check out repairstemcells.org (don margolis)

  • dan fahy says:

    check out repairstemcells.org (don margolis)

  • Sharon Lloyd says:

    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.

  • Sharon Lloyd says:

    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.

  • Barbara Hanson says:

    As someone who has had offshore treatment for a terminal lung condition, I have no fear of the treatment when my own stem cells are used. I do fear non treatment and right now that is the only option available for me in the U.S. When a patient hits end stage, it means that there is nothing else their doctor can do medically to help them. The FDA is going to have its day in court to explain why fertility clinics are not subjected to the same type of regulations they are placing on stem cell clinics. They can also explain why they believe they have the authority to regulate the practice of medicine. Maybe, this will clear up why the U.S. has fallen so far behind many other countries in terms of safe, available treatments and stem cell based clinical trials. I applaud Drs. Centeno and Schultz and Ms. Cheever. They have forced this issue so that they can get a clear answer from the FDA. This has cost them a great deal of money and I for one am very grateful to them. I am co-founder of the Stem Cell Pioneers, but they are the real Pioneers.

  • Barbara Hanson says:

    As someone who has had offshore treatment for a terminal lung condition, I have no fear of the treatment when my own stem cells are used. I do fear non treatment and right now that is the only option available for me in the U.S. When a patient hits end stage, it means that there is nothing else their doctor can do medically to help them. The FDA is going to have its day in court to explain why fertility clinics are not subjected to the same type of regulations they are placing on stem cell clinics. They can also explain why they believe they have the authority to regulate the practice of medicine. Maybe, this will clear up why the U.S. has fallen so far behind many other countries in terms of safe, available treatments and stem cell based clinical trials. I applaud Drs. Centeno and Schultz and Ms. Cheever. They have forced this issue so that they can get a clear answer from the FDA. This has cost them a great deal of money and I for one am very grateful to them. I am co-founder of the Stem Cell Pioneers, but they are the real Pioneers.

  • Barbara Hanson says:

    As someone who has had offshore treatment for a terminal lung condition, I have no fear of the treatment when my own stem cells are used. I do fear non treatment and right now that is the only option available for me in the U.S. When a patient hits end stage, it means that there is nothing else their doctor can do medically to help them. The FDA is going to have its day in court to explain why fertility clinics are not subjected to the same type of regulations they are placing on stem cell clinics. They can also explain why they believe they have the authority to regulate the practice of medicine. Maybe, this will clear up why the U.S. has fallen so far behind many other countries in terms of safe, available treatments and stem cell based clinical trials. I applaud Drs. Centeno and Schultz and Ms. Cheever. They have forced this issue so that they can get a clear answer from the FDA. This has cost them a great deal of money and I for one am very grateful to them. I am co-founder of the Stem Cell Pioneers, but they are the real Pioneers.

  • Don Margolis says:

    First, congratulations for a balanced stem cell article, something rare in the USA. Why? Because the FDA is owned outright by Big Medicine and nothing has ever threatened their now $2Billion per WEEK profits. If ever you had a doubt about this statement, all you need is study this case. The FDA routinely allows drug approval for its bosses, Big Pharma, on contrived clinical trial data—after all, they just have to donate a few million to Harvard and bingo—positive data appears to replace true data and thousands die. But one little guy threatens them with stem cells and the FDA calls out the Marines!

    So with 100% of major media owned and controlled by Big Business, with the FDA a criminal organization killing people by the thousands with unproven drugs (Just google “FDA Corruption” or “FDA Scientists”) and the sham Big Medicine backed stem cell club ISSCR saying whatever they want knowing no one will challenge them in any major medium, they can all pretend they care about the patients when their only goal is to keep all cures away from those who are suffering.

    Don’t believe that? OK, name one chronic disease conquered in the 60 years since Salk & Sabin kayoed polio. How about 75 years of the hoax American Cancer Society whose job it is to limit our cancer treatments to deadly chemo and radiation? No cures are allowed out of the lab and into the clinic under the FDA system…and none ever will be in significant numbers.

    THAT is what Chris Centeno is threatening and why the FDA is doing what it always does: making patients suffer. Nothing explains the criminality of patient-hating American Medical Science and the FDA better than this case. Money first; patients last.

  • Don Margolis says:

    First, congratulations for a balanced stem cell article, something rare in the USA. Why? Because the FDA is owned outright by Big Medicine and nothing has ever threatened their now $2Billion per WEEK profits. If ever you had a doubt about this statement, all you need is study this case. The FDA routinely allows drug approval for its bosses, Big Pharma, on contrived clinical trial data—after all, they just have to donate a few million to Harvard and bingo—positive data appears to replace true data and thousands die. But one little guy threatens them with stem cells and the FDA calls out the Marines!

    So with 100% of major media owned and controlled by Big Business, with the FDA a criminal organization killing people by the thousands with unproven drugs (Just google “FDA Corruption” or “FDA Scientists”) and the sham Big Medicine backed stem cell club ISSCR saying whatever they want knowing no one will challenge them in any major medium, they can all pretend they care about the patients when their only goal is to keep all cures away from those who are suffering.

    Don’t believe that? OK, name one chronic disease conquered in the 60 years since Salk & Sabin kayoed polio. How about 75 years of the hoax American Cancer Society whose job it is to limit our cancer treatments to deadly chemo and radiation? No cures are allowed out of the lab and into the clinic under the FDA system…and none ever will be in significant numbers.

    THAT is what Chris Centeno is threatening and why the FDA is doing what it always does: making patients suffer. Nothing explains the criminality of patient-hating American Medical Science and the FDA better than this case. Money first; patients last.

  • Don Margolis says:

    First, congratulations for a balanced stem cell article, something rare in the USA. Why? Because the FDA is owned outright by Big Medicine and nothing has ever threatened their now $2Billion per WEEK profits. If ever you had a doubt about this statement, all you need is study this case. The FDA routinely allows drug approval for its bosses, Big Pharma, on contrived clinical trial data—after all, they just have to donate a few million to Harvard and bingo—positive data appears to replace true data and thousands die. But one little guy threatens them with stem cells and the FDA calls out the Marines!

    So with 100% of major media owned and controlled by Big Business, with the FDA a criminal organization killing people by the thousands with unproven drugs (Just google “FDA Corruption” or “FDA Scientists”) and the sham Big Medicine backed stem cell club ISSCR saying whatever they want knowing no one will challenge them in any major medium, they can all pretend they care about the patients when their only goal is to keep all cures away from those who are suffering.

    Don’t believe that? OK, name one chronic disease conquered in the 60 years since Salk & Sabin kayoed polio. How about 75 years of the hoax American Cancer Society whose job it is to limit our cancer treatments to deadly chemo and radiation? No cures are allowed out of the lab and into the clinic under the FDA system…and none ever will be in significant numbers.

    THAT is what Chris Centeno is threatening and why the FDA is doing what it always does: making patients suffer. Nothing explains the criminality of patient-hating American Medical Science and the FDA better than this case. Money first; patients last.

  • Mayr says:

    Dr. Centeno is putting his practice on the line for everyone that is using ADULT stem cells. This has nothing whatsoever to do with embryonic stem cells. The public has been misled and taken to the cleaners as taxpayers. This is the practice of medicine. The FDA has no authority to regulate a person’s own stem cells. Do you think for one minute that a heart surgeon calls the FDA for permission to take a vein from a person’s leg and use it in his heart? I think not. The FDA, as it runs today, should replaced or abolished. They also are a waste of money!

  • Mayr says:

    Dr. Centeno is putting his practice on the line for everyone that is using ADULT stem cells. This has nothing whatsoever to do with embryonic stem cells. The public has been misled and taken to the cleaners as taxpayers. This is the practice of medicine. The FDA has no authority to regulate a person’s own stem cells. Do you think for one minute that a heart surgeon calls the FDA for permission to take a vein from a person’s leg and use it in his heart? I think not. The FDA, as it runs today, should replaced or abolished. They also are a waste of money!

  • Mayr says:

    Dr. Centeno is putting his practice on the line for everyone that is using ADULT stem cells. This has nothing whatsoever to do with embryonic stem cells. The public has been misled and taken to the cleaners as taxpayers. This is the practice of medicine. The FDA has no authority to regulate a person’s own stem cells. Do you think for one minute that a heart surgeon calls the FDA for permission to take a vein from a person’s leg and use it in his heart? I think not. The FDA, as it runs today, should replaced or abolished. They also are a waste of money!

  • Brian says:

    My son had autologus bone marrow stem cell treatment in March 2010 in a clinical trial in Mexico..

    Brain Injury at 4 months of age, many delays but the biggest problem was the seizures..Within 3 years I am positive I easily witnessed him have over 5000 seizures..Do the math, it is more then a couple evey day..Numerous medications did nothing..And they never showed signs of slowing down only getting worse…

    Within 2 weeks of stem cell treatment..80 percent of seizures stopped..Now we are 5 months post stem cell treatment and it has been 15 days with NO seizures..They are gone for the first time in 3 years..

    We had EEG before treatment and have scheduled an EEG to confirm..Should be very useful evidence to someone…

    Two Thumbs up for adult stem cells…

  • Brian says:

    My son had autologus bone marrow stem cell treatment in March 2010 in a clinical trial in Mexico..

    Brain Injury at 4 months of age, many delays but the biggest problem was the seizures..Within 3 years I am positive I easily witnessed him have over 5000 seizures..Do the math, it is more then a couple evey day..Numerous medications did nothing..And they never showed signs of slowing down only getting worse…

    Within 2 weeks of stem cell treatment..80 percent of seizures stopped..Now we are 5 months post stem cell treatment and it has been 15 days with NO seizures..They are gone for the first time in 3 years..

    We had EEG before treatment and have scheduled an EEG to confirm..Should be very useful evidence to someone…

    Two Thumbs up for adult stem cells…

  • Brian says:

    My son had autologus bone marrow stem cell treatment in March 2010 in a clinical trial in Mexico..

    Brain Injury at 4 months of age, many delays but the biggest problem was the seizures..Within 3 years I am positive I easily witnessed him have over 5000 seizures..Do the math, it is more then a couple evey day..Numerous medications did nothing..And they never showed signs of slowing down only getting worse…

    Within 2 weeks of stem cell treatment..80 percent of seizures stopped..Now we are 5 months post stem cell treatment and it has been 15 days with NO seizures..They are gone for the first time in 3 years..

    We had EEG before treatment and have scheduled an EEG to confirm..Should be very useful evidence to someone…

    Two Thumbs up for adult stem cells…

  • Brian Sanderson says:

    I have received one re-injection of autologous MSC at the Centeno-Schultz Clinic. Yes, it has helped me — more function and less pain. Originally, I expected to need 3 re-injections to treat three cartilage problems in my right knee. And then the FDA screwed things up!

    Peer-reviewed scientific publications demonstrate the efficacy of cultured autologous MSC to treat cartilage problems. Personally, I’m not at all swayed by testimonial evidence of the kind “well I suffer less pain after the treatment”. When that testimonial evidence is backed up by MRI evidence and histology (one of the Japanese publications) then I start to think there might be something in this clinical procedure. I become somewhat more convinced when there is a clear mechanistic relationship between objective measurements (MRI) and more subjective things like pain.

    There are also publications indicating that autologous MSC treatments can be safe as practiced in some clinics. You don’t have to be a genius to read and understand this stuff.

    Scientists adapt their methodology to the phenomenon at hand. It seems to me that FDA (and some others who have commented above) are stuck in a bureaucratic rut — they have their hammer and see everything as a nail.

    • Alex says:

      I’m getting an adult stem cell therapy in Germany in 3 weeks. I’m doing it to hopefully avoid a heart transplant or even certain death by the age of 40. I will take my chances with the stem cell treatment. Anyone that wrote in this blog that does not support the use of stem cells has never been in the position that i’m in. I challenge anyone who does not support the use of stem cells to put themselves in my shoes and then turn down the chance to receive a stem cell treatment. I dare them. Whether the stem cell is used to fix a sports injury or to save a life the decision should be left in the hands of the patient. Internationally and here in the USA, research shows across the board that there is no harmfull side effects. And if i end up getting some terminal side effect from this proceedure, it was my choice. Is anyone paying attention to the side effects of sleep aids or birth control pills…. holy cow that stuff will kill you for sure. No one has had any negative side effects to using their own bone marrow/stem cells to heal themselves. Do your research non believers. I have reviewed and spoken with high end doctors from all over the world at this point and investigated and reviewed many clinical trials here and overseas. Anyone out there care to prove me wrong… go for it post something with real data thats been proven and documented , published or peer reviewed and then illl listen.

      Alex

  • Ivan Malagurski says:

    If it works so well, they should file it with the FDA and get it out in the world…

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