Anyone have objective data on the effectiveness of the Regenexx stem cell procedure?

At the Regenerative Sciences, Inc. site, you can find some comments. You might wat to join the site and get some better information.

I would be very, very wary of this procedure. I read over the FAQ at the Regenexx website and I have significant concerns. My primary concern is that it has not undergone rigorous clinical trials. They talk about “surveys” with patients “reporting relief”. That is not a valid clinical study, nor does the company apparently feel the need to conduct one.

Moreover, they explicitly state in the FAQ itself that the FDA has no jurisdiction to approve this procedure since it is surgery (even though they are using autologous stem cells) and because they specifically avoid any interstate “aspects”, which might also invoke other states’ laws and/or FDA approval.

If you were to go for this procedure, realize that it has not been validated, and is experimental, at best. Given that it is not covered by insurance, your out of pocket expenses would be extensive, with little guarantee of success.

Finally, to attack the science behind this, yes stem cells have remarkable potential. But, simply injecting stem cells somewhere doesn’t guarantee that they will differentiate appropriately and grow/develop correctly. There is a lot of hocus pocus with this technique. If you were my patient, I would urge you to be very cautious.

Also, I forgot to mention that objective data will be hard to come by, seeing as how there is no clinical trial from which to base decisions. I initially started with a search of the medical literature, but when I drew a blank, I resorted to Google, and had to rely on the Regenexx website. So, I fear you won’t be able to get real objective date, which is a shame given how much they charge for the procedure and the time-effort required on the part of the patient.

I’m glad I’m not your patient as you sound like you would recommend invasive procedures that may or may not work either. I would much rather try stem cell treatment first. There are close to 10,000 peer reviewed published articles on mesenchymal cells (which is what Regenexx uses) available to anyone who cares to read them. Regenexx has 4 years of hard data from their clinical procedures as well. As for cost, you are basing your criticism on an insurance covered procedure vs. a non insured procedure. If someone does not have insurance and opts for your type of invasive procedure, it is going to cost more than a stem cell treatment. Unfortunately, stem cell treatments for the most part are not a covered procedure, but this will be changing in time. Stem cell treatments will probably become the norm as more and more people opt to avoid invasive surgery and the risks that it entails. Drs. Centeno and Schultz are caring doctors with many outstanding credentials. Dr. Centeno is the founder of ASCTA (American Stem Cell Therapy Association) www.safestemcells.org or www.stemcelldocs.org if you are a physician. This grassroots effort is gaining momentum. The FDA has been hanging many of us out to die. This effort is challenging the FDA’s regulation of our own stem cells as prescription drugs. Undoubtedly, this was a combined effort from the FDA and Big Pharma ties that permeate the agency that was and is supposed to protect us. Instead, it is killing many of us. I do not want to continue off subject, so I will just say that as co-founder of www.stemcellpioneers.com, our forum gives a thumbs up to Regenexx. The forum is patient moderated and only allows a company/doctor to participate if they have high patient satisfaction and results. Regenexx has both and is a welcome participant on the Pioneer forum.

Let me address your comments point-by-point:
1. You would recommend invasive procedures that may or may not work either. I would much rather try stem cell treatment first. Right. I would follow the results of actual clinical trials, for which there are NONE for Regenexx. You can feel free to “try” anything, but there are risks and costs with any procedure.
2. There are close to 10,000 peer reviewed published articles on mesenchymal cells (which is what Regenexx uses) available to anyone who cares to read them. So what? That is like saying there are 10,00 articles in the New York Times about George Bush. Yes, mesenchymal cells are part of the human body (thus justifying research on their function). So are hundreds of other cell types. Where are the double blind clinical trials comparing Regenexx to placebo?
3. Regenexx has 4 years of hard data from their clinical procedures as well. They should publish their results in a peer-reviewed journal.
4. Stem cell treatments will probably become the norm as more and more people opt to avoid invasive surgery and the risks that it entails. Yes, that would be terrific, ONCE the clinical trials PROVE the worth of stem cells for this purpose.
5. The FDA has been hanging many of us out to die. This effort is challenging the FDA’s regulation of our own stem cells as prescription drugs. Really? Stem cells are used regularly as treatments for various cancers, and the FDA is actually far too lenient in approving treatments in general, as has been publicized by the New York Times.
6. our forum gives a thumbs up to Regenexx. Again, I ask, so what? People are free to believe what they want. But, science should be objective to emotions. You may feel an emotional attachment to this procedure, but that doesn’t mean it works.
7. The forum is patient moderated and only allows a company/doctor to participate if they have high patient satisfaction and results. So it’s a self-selecting group. If you cater to patients, irrespective of ACTUAL RESULTS, you are in. If you have negative results, you are out. Surprise! Everyone is so positive here!

Shilling for this company and your web forum smacks of spam. I didn’t flag your quip simply because I find it more relevant to dispute your comments.

And just who are you “shilling for”? I always find it interesting that people that make posts such as yours do not honestly identify themselves. I have stated who I am and only give the links as a source to verify what I have stated. I can just as easily remove them and still say I think your post is not in the best interests of the patient in my opinion. Invasive surgery is always risky. I have a terminal disease and honestly don’t give a darn about what the New York Times (which is a questionable resource at best) has to say about the FDA and its so called leniency. Is my terminal disease safer? I think not. The FDA apparently thinks it is as they would prefer that years worth of clinical trials be conducted for each and every disease application using our own stem cells. Well, whoever you are, most of the people on the Pioneer forum will be dead by then. President Obama campaigned on change and transparency and the FDA is certainly in need of both. If you do not agree, then please inform us of your true identity and tell us why the FDA should be allowed to let us die. I would really like to hear your answer. If you are truly a physician you should be particularly worried about the change in regulatory policy that the FDA has made. You may find them regulating every facet of your business as well. Congress never gave them the power to regulate the practice of medicine. Keep that in mind before you do too much cheer leading. Thank you as well for helping to diminish hope for the over 110 million people in this country who are fighting terminal and chronic diseases 24/7. We deserve the right to have treatment using our own stem cells now if we so choose. We currently can have blood transfusions and invitro fertilization, so this regulation is really giving a double standard to such procedures.

I’m sorry you have a terminal disease. Yet, the history of medicine is littered with false hope for patients, who, given the circumstances are willing to try anything and everything for a cure. That is understandable. However, the role of medical science is to adequately test new treatments so as to “do no harm” and also to actually provide benefit.

As for your question, I shill for no one, and in fact am much more transparent about my experience (see my profile, if you choose). I have been on this site for more than a year, providing medical and science advice to anyone who chooses. I have both a medical degree and a PhD in immunology, so I am well versed in the promise of stem cells. But that is just it. Stem cells hold great promise, but actual benefit (besides stem cell transplants as rescue therapy for marrow-ablative chemotherapy for cancers) has been hard to prove. Likewise, gene therapy was supposed to be a panacea when I started medical school almost 20 years ago. It has yet to prove its worth.

My concern is in fact for patients, and I would hate for people to chase false hopes. Your quip is littered with hyperbole. If the FDA didn’t regulate drugs and treatments, all forms of horrible treatments would be out there, and people wouldn’t know who to trust. Perhaps they are slow sometimes, but there is a fast-track mechanism for approving important drugs. Sometimes that is too late, but other times, the careful vetting of drugs prevents dangerous agents from coming to market and doing more harm than good.

Finally, and most importantly, this is a question and answer site after all, and the questioner specifically asked for “objective data” on the benefits of Regenexx, not testimonials or personal anecdotes. As I answered (and as you have done little to dissuade), there is no OBJECTIVE data for its benefit.

Testtoast99..
To your questions about Regenexx, I don’t believe you can find an unbiased double blind/ placebo controlled study for the efficacy of their “Regenexx procedure”. I don’t believe that it exists.

Clinical trials do cost $millions of dollars. I have met Dr John Shultz today for the third time and Dr Centeno twice last year. This is their procedure; they are regular working doctors that actually show up at work @ 7AM to do the bone marrow draws themselves.

To the best of my knowledge the corporation of Regenerative Sciences isn’t funded by a multibillion dollar corporation back in New York City. Their corporation was started in a similar fashion to William (Bill) Hewlett and David (Dave) Packard who created HP the computer company we know and love today. HP was founded in a garage. Regenexx was started in a clinic outside Denver.

As for experiencing the procedure, yes I have. I was in their offices today for my second bone marrow draw. I have had a total of 3 injections so far with much improvement in my knee. I am not fully healed but I am much improved in my left knee. I’m paying for all the procedures, flights etc. out of my own pocket & it’s not cheap. However I want to enjoy my life without arthritic pain.

It was this story here that convinced me that Regenexx was a real clinic
http://www.pittsburghlive.com/x/pittsburghtrib/s_578202.html

As for the naysayers on this board, everyone has an opinion & freedom of speech is blessed in the US. Testtoast it is for you to do your own research. Abrogating your personal responsibilities to the FDA isn’t safe, as the FDA have had their howlers in terms of Celebrex Vioxx Plavix Paxil etc to name but a few drugs released & “Blessed” by them.

At the end of the day the FDA is a US Government agency. Not unlike the US Treasury. Isn’t it the US Treasury along with FDIC and the Federal Reserve that was asleep at the wheel when the current economic holocaust started!

If you feel you need double blind controlled studies on Regenexx you may be waiting about 5–10 more years, for me I want my knee working without arthritis now.
JM
BTW have you found kneeguru yet? You can read a lot about Regenexx there too.

@mccartjt I see you heeded the call from the other message board to come and post here. The simple question I ask is this. If the doctors behind this protocol TRULY believed in its efficacy, why don’t they recruit patients the right way and perform even a small randomized study? They obviously were able to recruit patients to come and pay out of pocket, why not advertise locally (I see the company is in Colorado) and recruit 40–50 patients, and randomize them to treatment versus sham (this has to include the bone marrow harvest, of course). Then, have a blinded orthopedic surgeon evaluate each patient before and after treatment. A published study in a quality journal would go a long way towards making this an established technique.

As far as being a naysayer, you and the other writer have me wrong. I would love nothing more than for stem cells to become the next great wave of treatment in medicine. However, this can only occur if the studies are done right, and the way this company (and apparently many others) are doing business is ALL WRONG. FYI, all procedures come with risk, like infection and bleeding. What would happen if you developed a serious MRSA infection in your knee owing to this injections associated with this procedure (serious staph infections are on the rise)? You could suffer greatly, and even die. It is experimental after all.

A word about the FDA and your metaphor regarding the economy. I think you have it backwards. The reason the economy failed was due to lack of oversight, and lack of regulation. Your argument is that the FDA is blocking the bounty of stem cells because of its excessive regulation. Yet, isn’t that what should have happened with the economy? More regulation? Thus, the FDA is doing a good thing, not a bad one.

Lastly, over the past few hours I’ve actually read multiple papers by Dr. Centeno, and let me just say, I am not impressed. The ONE (yes one) actual (I hate to use this word) scientific paper describing this procedure was so flawed as to be embarrassing. The paper describes a “clinical trial” with inclusion and exclusion criteria, but eventually only describes ONE PATIENT that was hand selected by a pain physician (I wonder who that was?). This patient then undergoes the procedure, and lo and behold, feels better at the end. They even state that he has statistically significant improvement in his cartilage size. How is that even possible? Anyone who has taken basic statistics knows it is impossible to calculate statistics with a sample size of ONE. More importantly, having direct knowledge of the patient skews the results, and of course, it is possible the patient was compensated for his time by getting free treatment. Do you think he would then be honest in his assessment? I doubt it. The whole study is uninterpretable.

I regret to tell you that medicine is imprecise, but the best thing we can do long term for our patients is to follow accepted scientific and ethical behavior. I truly hope stem cells are our future, but as I mentioned above, 20 years ago gene therapy was our future, and in the intervening years, patients have died in clinical trials and positive results have been exceedingly rare. Caveat emptor.

@StemCellPioneers i’m also a physician, although not with as much experience as @shilolo since it hasn’t been that many years sicne i graduated. I’ve read a few peer review articles on mesenchymal cells and was wondering… does the fact that you mention there are close to 10,000 of them available mean there are close to 10,000 glowing endorsements for the use of said cells in specific therapies?

I’ll admit that there is great promise in stem cell therapy (and hoped to God it had been available to treat my father and grandfather for their terminal conditions) but i’d like (as i’m sure the original poster would) to see some form of unbiased clinical information relating to the specific plausibility and effectiveness of said treatments in a variety of clinical settings.

I’m not knoking your website and/or group… i’m sure that the patient review on there is great, but where are the reviews from patients/physicians that haven’t had a good success rate? Where is the independent study not conducted by Regenexx? where is the statistical data proving the benefit of this treatment over other more conventional procedures?

Where outside the sites you mentioned (which i’m sorry to say can hardly be considered impartial) can one find detailed information on both success and failure rates for the treatment? where can one find validated and revcognized scientific data that specifically backs up your claims? Are you suggesting that the 10,000 peer reviews you mentioned all support your POV?

The point of this question was not to find an advertisement for the procedure but rather to find testimonials from actual patients for the specific condition mentioned (@mccartjt i’m looking at you) and for any UNBIASED clinical information.

I;m sure your site is great and you all love the procedure… but you didn’t really answer the question.

Clinical trials run by the people who designed the therapy being tested is not only biased.. it’s untrustworthy at best. Blaming the FDA for the death of patients is not only extreme… it’s akin to blaming them for causing illness to begin with. Sure they can be slow in approving some medications and have approved some that should not have been allowed on the market, but their process weeds out far more bad drugs than are allowed for human consumption and is an evolving process wich learns from previous mistakes… so while i’m sorry if you feel it takes too long for a drug to go through.. the benefit of having it tested thoroughly will help a great number of people in the long run with diminished risk. Oversight is the key.

So if the treatment works.. AWESOME! have it put to the test in a valid clinical trial to prove it! Just don’t try to pass off clinical information gathered by the doctor who invented the procedure as impartial or unbiased… even the most naive of patients would have a hard time believing that one.

You have me totally confused now. What good are testimonials from actual patients as far as scientific evidence goes? The Pioneer forum discusses all diseases and encourages input good and bad from actual patients who have had stem cell procedures. We are not limited to orthopedic discussion. A majority of the members have terminal diseases or are in constant chronic pain. Try living with one of those 24/7 and you will understand why we are fighting to keep our own stem cells away from the domain of large pharmaceutical companies. We do not feel that our own stem cells should be regulated as prescription drugs. I have no argument with you as far as the FDA’s process for approving other drugs. My argument is that my own stem cells are not drugs, a point you seem to have not understood. There have been thousands of stem cell treatments using A-ASC’s successfully in clinics outside the U.S. Do not get hasty and think that these clinics/doctors are inferior to those here in the U.S. as many of the same doctors also treat patients here as well, but by law must take patients that request or require stem cells outside the country to be treated. It is not really oversight that we are talking about, it is control. Control that is not being exerted on fertility clinics, blood banks or surgeries, so why the double standard? If you keep up with the news, many drug companies are now stating that they will be taking their clinical trials overseas to China and India because it is cheaper and the pool from which they can select participants is larger than what the U.S. can provide. This means that less clinicals will be available to those of us who are dying. Therefore, by denying us treatment, I do not feel that blaming the FDA is extreme. If the FDA was not standing in the way, many competent stem cell doctors would be following ASCTA guidelines and treating patients in the U.S. today. I only wish I had a blown knee or a bad hip, but I am not that fortunate. I do know that I would go to Regenexx if I did. The company treats major sports figures and quite frankly I believe that is an excellent testimonial if one is into testimonials.

I have no argument with testimonials and am sorry that you suffer from such a terrible condition. HOWEVER i’m not in the US and my question still stands… is ther any available unbiased information on the effectiveness of the treatment?

I’m not arguing about the FDA trying to control your stem cells or my stem cells or my neighbor’s cells… i’m wondering if (beyond specific personal experience) there is any valid and unbiased information that specifically states that the treatment is a safe and valid option in a suficient percentage of patients to be considered for widespread use.

I have no complaints about physicians from anywhere outside the US conducting trials or any kind of research…

One more thing… the FDA is NOT denying you treatment… the FDA has no control over you going abroad to get whichever therapies you choose… and has approved many many many different kinds of drugs/therapies.. just because they haven’t approved the specific one you want does not mean they are letting you die. There are still other options and avenues for you to pursue.

btw.. the original question still has not been answered.

@StemCellPioneers The FDA is also out to prevent people from being taken advantage of (I only wish they extended their reach to other things, like homeopathy). How will you or anyone ever know if the $100,000 you spent on 4 stem cell procedures is worthwhile or wasteful? What about the people who may forsake other therapies for it? Or the people who suffer complications? You seem to think that somehow giving yourself an infusion of your own stem cells will be a panacea. Don’t you realize that those stem cells are already there? If they were going to help, they would have already. The only known success with stem cells is when they are given to people whose bone marrow has been ablated by chemotherapy, and the stem cells recolonize the bone marrow. As for the other examples you gave, I await a legitimate, well-done study, here or abroad.

You’ve brought up fertility doctors and blood transfusions. Both are well established (and regulated, FYI), and have been utilized for decades if not a full century (for blood transfusions). What is your point exactly? Again, I truly WISH for stem cells to become an effective treatment for a multitude of conditions. But, we will never know if the therapy WORKS unless it is studied rigorously. To take a point from @mccartjt, look at celebrex. It was approved by the FDA and many people used it for pain relief, but only after extensive post-marketing analysis was it clear that it increased peoples’ chance of stroke. Without that oversight, it might have gone unnoticed. Same goes for any new treatment. Without rigorous study, both before and after, we can never know if a treatment “works”, of if a patient has simply experienced a placebo effect.

To all on this board,
I am sure in fullness of time, there maybe someone that funds a double blind study for the Regenexx procedure. In the mean time, given the choices of going overseas to some completely uncontrolled doctor in China (for example) or a doctor that is practicing medicine as he feels the law as it stands in the state of Colorado, I’ll take the doctor in Colorado.

My own (independant) orthopaedic surgeon is following my own procedure, and is greatly encouraged with the results he’s seen and heard so far. I have copies of my before and after Tesla 3.0 MRI images & yes my knee does feel better. My blood pressure is down too, as I’ve been able for the first time in 14 years to put in substantial aerobic workouts in the last 6 months. For everyone’s information Osiris has done a clinical trial shown here.

http://www.osiristx.com/clinical_trials_chondrogen.php

The difference main difference between the two procedures is that they have used “Allogenic” stem cells which I find very dangerous where as Dr Centeno has used autologus stem cells.

Personally I ‘d far rather put cells back into my body that have come from me than from anyone else. Yes there are choices I have made, I’ve consulted some of the world’s finest surgeons & have had arthroscopic surgeries in the past yet none of those have repaired my knee. So I have taken a chance with my life, as we all have in the past.

One cannot put one’s blind faith in the FDA. History has taught us that. Millions of dollars have been spent by big pharma to make drugs and profits these two issues are direct opposites from the terms of the safety for the patient’s point of view. Lobbyists have been hired just to persuade the FDA in the “Right” direction. Here is a link to Wikipedia ‘s listing on Celebrex

http://en.wikipedia.org/wiki/Celebrex

People have died from using Celebrex. Where was the FDA on that drug? Asleep at the wheel I’d humbly suggest

As for the economy, TPTB were asleep at the wheel. There was plenty of warnings by knowledgable folks that said that the economic experiment would end badly. It did.

The double standard of allowing fertility clinics to expand cells at the very creation of life versus the FDA’s opinion that my own stem cells have now become a drug is frankly bogus. If an egg and a sperm can be joined outside a body & re-introduced a la “Octomum” why can’t I get my knee rebuilt with my own stem cells? & BTW where was the FDA’s oversight of “Octomum” too?

One more point. I pointed earlier to the story of Dr Joe Maroon who was facing a total knee replacement. I have an acquaintence who has had a double TKR. With the benefit of hindsight he said he wished he could have turned back the clock and tried the stem cells first. The pain from the TKR’s was excruiating. The cost was very very expensive too.

FWIW, I now believe that Regenexx has files on 500 patients.

This is Dr. Centeno, I’m on vacation, so sorry for the tardiness of a reply. We have several larger case series that have been submitted for publication. We are now training a clinical site for a larger RCT. It looks promising that funding may be available for the larger controlled studies. I think there is some confusion on research and medicine. While we MD’s are proud of our research heritage, recent meta-analysis of day to day clinical medicne show that 87% of what we all do everyday has no type 1 evidence support. Does this mean we should stop almost all medical care in the US? No, that’s why our legal system leaves doctor-patient decisions to doctors and patients.

In a disease where progression over time is a certainty, limited imaging evidence of disease regression is very valid. In the case of disc disease our site has multiple such MRI examples. What such data doesn’t speak to is generalizability, meaning does the procedure provide reliable results in large populations, hence our data submission and clinical site above.

As far as offering care without generalizability data yet available, type 1 evidence is lacking for all alternatives to treat dgenerative discs including epidural injections, laminectomy, and fusion, so all physcians practicing in this arena also lack substantial proof that their treatments are ultimately effective.

I apologize for the brevity of the response, as typing this on an iPhone is a challenge.:)

@Dr_Centeno Thank you for your comments. However, it doesn’t seem as if you addressed the question regarding having objective data for this specific procedure. Also, I am most certainly not confused about the relationship between research and medicine. I know full well how both bench and clinical research should be conducted, both ethically and scientifically. Your assertion that there is a lack of randomized double-blind data for certain procedures doesn’t provide an excuse to avoid doing it for other procedure (though, even surgeries as complex as heart bypass have been studied in randomized, blinded clinical trials).

A relevant example is this study of arthroscopic surgery of the knee published in the New England Journal of Medicine, where patients were actually randomized to arthroscopic surgery, lavage or placebo (a sham procedure that also involved a true surgical incision). The results showed NO BENEFIT to lavage or debridement versus placebo, although all patients reported improvement undoubtedly due to the placebo effect. To their credit, the authors reported this negative result that should impact a large number of procedures. Here is a procedure that everyone thought “works”, and yet, the data do not support its use. So, I ask, why not follow the gold standard (i.e. a randomized double blind study) rather than invent your own standards?

In light of your other comments regarding evidence-based medicine, I would ask you to provide the citation. In my practice, most of what I do IS evidenced based. Antihypertensives, cholesterol lowering drugs, aspirin, diabetes medications, antibiotics, anti-retrovirals have all been tested in randomized control studies.

Finally, I will say again, I am in favor of stem cells as a possible future treatment. But, avoiding clinical trials with the notion that these are “your cells” and bemoaning the role of the FDA is not the appropriate way to conduct research on stem cells. All it will take is for a few unfortunate patients to acquire a disease from the passage of autologous cells in the lab (i.e. due to contaminated media, for example) for the whole field to suffer a serious setback (much like the severely negative impact on the future of gene therapy by the death of a patient in a study several years ago).

One problem I see is that there are so many different egos in the scientific community. It also is apparent that many are not interested in any type of change whatsoever and would like to continue in the old ways forever more. I also do not understand where anyone has gotten the notion that I paid $100,000 for my treatments. My two bone marrow treatments cost $1500 each. My last treatment was $4000.00. On the other hand, a lung transplant which is most certainly iffy even though it is an approved procedure, would run between $300,000 to $400,000 exclusive of the lifetime of anti rejection drugs I would need to be on. Yes, a person can spend $25,000 for a treatment, but this is most likely something more complicated such as treatment requiring lumbar puncture or possibly umbilical cord stem cells. It is not one price fits all and a patient must be very careful when researching a clinic that he or she understands what type of treatment they will be getting. There simply are no horror stories coming out of foreign clinics giving autologous adult stem cell treatments. I certainly cannot consider stem cells a “future treatment” as you state because without trying treatment now, I have no future. It is as simple as that for people with a terminal disease. It’s really shocking that no support is even mentioned for those of us who should be allowed to have this treatment as a life saving measure with the FDA’s blessing. ASCTA has included compassionate use in the guidelines which is more than I see coming from physicians and scientists that post a lot of medical gibberish that means little or nothing to someone who is suffering. I am not advocating treatment that is so questionable that one could suffer worse for having tried it. In the case of A-ASC treatment, there is enough evidence from other countries to make most anyone with mobility and the funds willing to take the plunge.

In the U.S. horses and dogs can legally have treatment. If you want to know how well stem cells are working for animals, it is a subject easily researched on Google. One thoroughbred race horse had stem cell treatment and went on to win a million dollar purse. Dogs with hip dysplasia are showing great progress.

I almost laughed when I read that even one serious setback would cause the whole future of stem cell treatment to be in jeopardy. I seriously doubt it. There are billions of dollars invested. Foreign countries that are friendly to stem cell treatments are enjoying the economic windfall that has come with this new technology. I have read a story about a young boy who got tumors after some strange fetal cell cocktail in the Ukraine. That circulates a lot and yet it hasn’t stopped anyone that I know of from seeking treatment. It hasn’t stopped the researchers that I know of from continuing their work. It hasn’t stopped doctors from giving stem cell treatments. My own brother-in-law almost died from a staph infection he acquired in a hospital in Idaho. Look how many FDA approved drugs have caused deaths to millions and yet as a country we still are stuffed with drugs from cradle to grave. I will continue to Pioneer and be grateful for the doctors that are out there doing the same.

I’m really glad these procedures give you hope, but when I read on your very own site about children being treated for autism with stem cells, it is very upsetting. As a consenting adult, you can feel free to pursue whatever modern version of snake oil you want, but to promote stem cells as a cure for childhood diseases, or for chronic debilitating diseases that have no connection to stem cells (like Alzheimer’s or multiple sclerosis) is wrong. These modern-day hucksters are simply taking advantage of desperate people. Infusion of stem cells just sounds so sexy that it must work. Yet, without actual DATA, there is no way to know whether stem cells can join the list of effective treatments for a variety of ailments, or simply go down in history as another promising treatment that failed to live up to expectations.

By the way, in the process of expanding and differentiating the cells ex vivo, any number of things could happen to the stem cells to alter their biology. For example, it isn’t outlandish to think that injection of an extra population of stem cells that are actively dividing could result in cancer, or other unwanted results. Perhaps for someone with a terminal illness, this is a risk worth taking. But, for individuals not facing a terminal disease, that risk may be too much. The dearth of viable clinical data makes it impossible to know.

I was surprised to see your sudden alarm for children whose parents have chosen to have stem cell treatment for them. Most parents usually spend a great amount of time prior to making the decision to have stem cell treatment for their child exhausting all other means of treatment that their physician has to offer. This is not a decision made lightly on the spur of the moment.

I got this in my alerts e-mail today and found it quite timely to this discussion:

WASHINGTON (Reuters) – A study that found possible heart risks with attention deficit drugs had limitations and should not prompt parents to stop giving the medications to children, the U.S. Food and Drug Administration said on Monday.

The FDA said the study published on Monday in the American Journal of Psychiatry found there may be an association between use of stimulant medications used to treat attention deficit hyperactivity disorder (ADHD) and sudden cardiac death in healthy children.

“Because of the study’s limitations, parents should not stop a child’s stimulant medication based on the study,” an FDA statement said.

Stimulant medications used to treat ADHD include Novartis AG’s Ritalin and Shire PLC’s Adderall and Vyvanse.

Evidently, if a study is limited, according to the FDA, then it is acceptable that a potentially dangerous drug should be continued to be given to children. And you are asking me to accept that the FDA is not taking advantage of desperate people in order to not upset the apple cart with the manufacturers of these drugs? What good is a study, if the advice is to ignore it? You argue that stem cell treatments may be harmful and therefore should be avoided because of a lack of data and studies and yet it is evidently okay for parents to risk their children’s lives if the FDA lacks data on a drug and the studies are limited.

I also don’t understand where you feel that anyone is promoting cures with stem cells. I do not know of a single reputable stem cell clinic or doctor that would even use the word cure. Please do not mislead people with your intentional errors.

@StemCellPioneers I think you raise an interesting argument, but not for the reasons you list. The FDA is at least trying to base decisions on ACTUAL DATA, whereas there IS NO VERIFIABLE DATA on the therapeutic use of stem cells. What the FDA is saying is that the study is limited, and thus should be interpreted with caution. Therefore, they are being CONSISTENT. Flawed or limited data does not equal legitimate data on which to base decisions. So yes, “if a study is limited, according to the FDA, then it is acceptable that a potentially dangerous drug should be continued to be given to children.”

I don’t have access to this particular study from home, but I can already tell you that retrospective case control studies can have significant problems with bias and confounding. See, this study states in the methods “The primary exposure measure was the presence of amphetamine, dextroamphetamine, methamphetamine, or methylphenidate according to informant reports or as noted in medical examiner records, toxicology results, or death certificates. ” Now, even without reading the paper, which I will, I can already identify a potential source of bias. Kids who experienced sudden death were probably a lot more likely to have an autopsy, where drugs would be found by toxicology, whereas the kids who died in auto accidents probably were less likely to have autopsies, and the investigators likely relied on interviews with the family (less reliable). Thus, I predict that when I read the study tomorrow, I will find more autopsies in the sudden death group, and thus a greater association of sudden death with stimulants (because they were found more frequently by a better method). We shall see.

In any event, at least the FDA is weighing DATA, pros and cons, etc. There have been many cases of the FDA pulling medications and-or issuing black box warnings (for example, the diet drug fen-phen). This is how the system works. No drug is perfect, and as such needs to be approved through prospective studies, and constantly reviewed via aftermarket analysis. If more proof accumulates indicating that stimulants are harmful in ADHD, you can be sure the FDA will pull the drugs from the market. In contrast, the stem cell “pioneers” are just pushing forward, without so much as a hint that there could be some benefit (save lots and lots of anecdotal stories, which could easily be attributed to placebo affects).

I will say this again (perhaps for the 5th or 6th time). As a physician-scientist I truly believe in the promise of stem cells. I really, really do. However, no one will ever know if stem cell treatments are effective if they aren’t studied in rigorous, well-controlled clinical trials. This is true of all new treatments. And I would ask, why are the purveyors of this treatment not the leaders in the field of stem cell research? You talk about “reputable stem cell clinic or doctor”, but I consider that a misnomer. No reputable doctor would perform these infusions without it being part of a clinical trial or as an already verified procedure. Furthermore, this thread has piqued my interest in this area, and I’ve been doing a lot of web research over the past few days. Interestingly, quite a few of the doctors and clinics discussed on your very site have had major legal and ethical issues (including doctors that are heavily promoted), which argues against them being “reputable”. The doctors who run these clinics may claim to be “scientists”, but in reality, the bulk of cutting edge stem cell work is going on in major academic hospitals, not small, private clinics run by doctors with little to no scientific training.

Finally, I really hope you find what you are looking for in stem cell infusions. Neither I nor any doctor wants patients to suffer needlessly, but apparently the majority of the medical community views the current status of stem cell treatments to be in its infancy. Many of us are concerned that the quixotic pursuit of highly experimental stem cell treatments could be detrimental on an emotional, financial, and possibly biologic level.

Shilolo

Are we not slightly off topic here? The original post was from someone who wanted to know whether the Regnexx procedure was safe and whether it worked?

What really is your beef here? Are you jealous of success?

At the end of the day if anyone haa a bad knee wouldn’t they like it better? Just like Testtoast99?

Shilolo

One more thing while we are on the FDA areas of expertise and authority.. Why doesn’t the FDA just flat out ban tobacco products? That would save millions of peoples lives, and, would be a noble cause!

@mccartjt This isn’t off topic in the least (the specific question asks for objectivity, and I am arguing with all of the non-objective posters here). All of the posters that suddenly materialized to tout the procedure appeared to be flagrant spammers, and as I have said again and again and again, there is NO OBJECTIVE DATA to support this procedure (have you provided any?). As far as I am concerned, anyone (including doctors) who promotes this as a legitimate therapy is operating contrary to established medical ethics.

Shilolo

& I have agreed with you. To the best of my knowledge there is no independently verified objective data, no double blind study. For all the studies, done on any drug or procedure, the real issue a patient wants to know, is does it work & is it safe?

So far with all the postings on website after website that I have read, I have yet to see any people complain having adverse reactions to the Regenexx procedure. Most people posting seem to be pleased with their outcomes.

To your point of it being a legitimate therapy, I have read that Dr Centeno met with three separate independent attorneys for their legal opinion prior to doing releasing this procedure on the public. It was their opinion that at that time the procedure was in fact not covered by FDA regulations. Since that time the FDA has sought to rule that my own body is a drug making machine, and that my own stem cells are drugs. Its my opinion that idea is bogus.

I have noted that on my suggestion above of the FDA doing their job you have so far chosen to ignore the 800lb gorilla, of stopping the sale of tobacco products. There has been as we both know, double blind studies done, on the deadly effects of smoking. Where is your outrage with the FDA not doing their job here pray tell?

Hi,
I am one of Dr Centeno’s patient’s,he has helped me with three different joints.I was told I need replacements in both knees and also was given an option to have my thumb/wrist fused.Dr C,gave me a chance to save what I have and it has worked! I was a grade 3–4 OA or DJD in all three joints and very stiff ,my pain level,range of motion and function have vastly all improved.My CMC,IP and Radial-Lunate in my dominant hand were all injected wiith .6 million cells.I have regained almost 20 degrees of range of motion in the flexion portion of my right hand/thumb.This is truly amazing and significant!I was fortunate last year to find a way to have this procedure covered by my health insurance.So,here is one patient happy with his autologous stem cell transplants!MB

@mccartjt If you want to build a straw man argument regarding tobacco, feel free. I am completely in favor of the FDA getting involved, but historically they have been prevented from going after the tobacco industry. So, they couldn’t “do their job” as you said, because they were prevented from doing so. However, new legislation just passed and signed by President Obama allows the FDA now to step in.

Getting to the heart of this issue, you said “the real issue a patient wants to know, is does it work & is it safe?” I agree 100%. This is precisely my argument. You cannot know whether something works or is safe without clinical trials. As I showed in a link above, a clinical trial published in the NEJM (the world’s most prestigious medical journal) showed that sham knee procedures provided the same beneficial response (owing to the placebo effect) as an actual surgery. So we now know that particular procedure doesn’t work. Likewise, aftermarket analysis of celebrex (a billion dollar drug) and fen-phen showed serious problems, and they were pulled from the market for not being safe. This is my point: Without careful study, we would have assumed the knee surgery “worked” (much like you do with the autologous stem cell infusion) and that celebrex is safe (millions of people took it without side effects).

As a vested interest in this procedure, Regenexx is not likely to publish negative results or report side effects, since they aren’t involved in a clinical trial and are flaunting existing regulations. In any event, neither you nor they can know whether the benefits experienced by individual patients are due to placebo effects or true biologic-physiologic improvement. Patient safety should be everyone’s goal. Even though you think it is safe because these are your cells, they have to be harvested (you can suffer a serious infection or bleeding), manipulated in the lab (contaminated with bacteria, yeast, fungi or worse yet, switched accidentally with another patient’s cells) and reinjected (bleeding and infection risk, again).

In the end, you can feel free to take whatever risks you want, but the job of the medical community and the FDA is to provide vetted treatments that work and will do no harm. At the present time, there is little to suggest that autologous stem cell infusions meet either of those two criteria.

Shilolo

I agree with some of your points. Yes there is a chance of infection at the lab, true.

Assume for a moment that the procedure were all of a sudden approved by the FDA, the risk of infection from the lab work would still exist. So that point is really moot. If you want win the lotto you naturally have to buy a ticket!

On a point of law, currently if the FDA could shut down Dr Centeno, they probably would try to do so, in the Denver federal courts. The FDA has published their open letter to Regenerative Sciences LLC (RSI) over a year ago now. Legal arguement is where the issue currently stands. Its the FDA’s new (& recently changed) position is that my body is a drug making machine, & the law as I understand says that is not the case.

Thus Dr Centeno and his associates believe that they are practicing medicine as the law in Colorado currently allows. That they are vigorously mounting a campaign to keep the status quo is their perogative. You might not like the law as it pertains to RSI, but we are all subject to it.

As for the FDA’s vetted treatments I’ve been waiting 4 + years for MACI to be approved by the FDA

http://www.genzyme.com.au/prod/maci/au_p_hcp_bio-maci.asp

Whilst that appears to be currently approved in Australia, I’ve been waiting 4–5 years for the FDA to make some moves on that here in the US. Your arguements (from your last posting) of contamination issues etc (N.B don’t for get the outside issue of the collagen too), would still hold water with a MACI procedure even though its approved in Australia?

There is with every procedure, risk. Personally I’ve chosen to go with Dr Centeno and his team. Rather than take a chance with some other suspect doctors of overseas locations where I would feel less comfortable. As for your point on the NEJM Dr Centeno uses that very same link to point out that even NFL’s Tom Brady has had issues with US surgeons doing their work

http://sports.espn.go.com/nfl/news/story?id=3658987

Nothing is guaranteed.. You pays your money and takes your chances.. I can speak from my experience, & so far I am happy patient.

JM

This guy asked for objective evidence not a debate. I know people who have had excellent results and also those for whom it was a failure. The company rates your chances of success and allows you to make a choice…. pay attention to this. People’s experience over time is meaningful and so are mris etc if you can read them or get someone to do this for you. (hint little arrows showing the differences are helpful but is not reading the MRI…Are there MRIs of people with this injury over the same time period with no procedure as some things just heal others do not…The stem cell process used has had many years success with large animals like horses.

Clinical studies are not always objective, the blinded are not always blind and the study can be written to favor the product. Reviewers are also not objective. The New England study is no role model yet it is quoted by people for FDA regulatory position and against it. What does life tell you….go to hospitals and physio places and ask how people who treat recipients see these individuals as progressing with this process in real life. I would use refs to link to and back all this up but there was talk going back and forth about spamming….

It is going to cost you either way, traditional surgery, leave it ,or try stems….The tumor factor is more of an issue with IPC or embryonic cells… mostly unless people are dead stupid about how long to let the cells grow out this is not a big issue.

I would want to know how they are growing the cells out specifically to be sure there was no PCR type cloning going on and that all ingredients used in the medium were safe for cell growth.Hormones and precursors may be safe for instance in some circumstances but not in others because of how they affect cell regulation and growth. Are they using animal or human growth mediums….wouldn’t wan’t prion disease or changes in the way the cell metabolizes to happen . What are the lab conditions….are the freezers cold enough not only to preserve but to prevent transmission of things like syphilis which is very resilient. What is going on for power back ups and how are the cells brought back from frozen to where they can be grown out.

Before considering a procedure I would look at the turn over rate of employees and if the ones they have now are happy. Did people leave their employ paid and happy? How an organization or company acts towards others in times of stress reflects how they will treat customers in less than ideal circumstances…..Sort of like looking at how people treat their relatives or pets and translating that to future relationships. Ethics and principle are kept in the heart and regulatory agency can often be bypassed with creative thinking….as one major medical equipment developer said coldly about his multi million dollar fines and fueds and retainers to assist in dealing with the FDA…“It is just the cost of doing business ”

What responsibility does the company take if the procedure causes you problems and who is paying. If it doesn’t work and the product improves will they offer you treatment at a reduced or free rate? One thing people fail to consider going international is that international law is not going to protect them and many of these countries need money badly. You are a foreigner and cash cow and they are going to protect their own leaving you without a leg to stand on…

As for tobacco, fatality failure affecting the science I agree…I don’t think the genetics where someone died was a double blind clinical but could be wrong…and for the med/science contingent why not spell out the risk you see for instance tumors, how/when/why/where…etc The FDA are wrong because…specifics would be helpful they are calling your cells a drug doesn’t say anything…..nor does the legislation said this and now it says something else. What legal rights do they have or no have to change policy and wording..who decides.

Also how about the risk/benefits of pusuing non FDA protocols….off label use…drugs and procedures grandfathered in….why a trial takes 5–15 years etc would be helpful. even simple things like will I go to jail if I use non FDA products…will my Dr lose his license/hwat is the difference between and FDA shut down and an untitled letter etc…People are just trying to get well and get information to do so…you all had to have this stuff down to get your PhDs so why not give a little real information

You know I have read everything through this debate and found it quite interesting. I have seen it go off track from the question and I have seen some interesting information. Such as that there is no type 1 evidence for any replacement or treatment. My own DR confirms this. I like the comment that checking into the emplyoees satisfaction in their work lead to more confidence in the company, but what I am concerned about is competition. I know they must be on the leading edge, but if this is such a good remedy why I am not finding other clammering to get on board? Competition brings forth improved procedures, more proof of the process. It also can bring aboad scammers, but by those appearing it brings more credence to the honest practices.
So why are there not more DRs. into this?????

@Bad_Knee There is no “debate”. This is a scam, plain and simple.

I have personally seen great, good and not so good results in others who have had stem cells. There is risk of infection at the lab or in the body with most procedures, FDA approval does not guarantee safety from infection.

Results over time with people I knew before and after and in comparison to other treatments on the market are promising. I certainly would not write them off as a scam. Stem cells are not new in treatments for areas like cancer but the technology to grow them out safely in numbers sufficient to make a difference is very new.

It has worked well in animal models without incident so I think labelling all stem cell treatments a scam is shortsighted. If you have evidence of a particular company engaging in fraudulent behavior why not call on authorities that deal with fraudulent activities to deal with it. for the sake of defenceless and vulnerable people.

There is a stem cell orrganization ISSCR that is making a PDF stemcell guidelines for patients that the national health organizations across Europe are recommending to help people differentiate between real treatments and not so reputable places http://www.isscr.org/public/index.htm. Many of the stem cell companies can not afford the legal and administrative cost of essentially getting through FDA legislation in the present economic climate

Most Drs I know are curious about stem cells but also want to deliver FDA approved treatments without controversy to their patients and will wait untill stem cells hit the mainstream before jumping on board.