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Thread: Exclusive: Doctors Skirt FDA To Provide Human Stem Cell Therapy

  1. #1

    Exclusive: Doctors Skirt FDA To Provide Human Stem Cell Therapy

    Wouldn't be nice to be able to do exactly the samething to the spinal cord and we recover from paralysis. I don't think it's inpossible to do with the right combo stem cell treatment.



    Exclusive: Doctors Skirt FDA To Provide Human Stem Cell Therapy
    76 Comments
    March 9th, 2010 by Aaron Saenz
    Filed under stem cells.


    The FDA has yet to approve stem cell therapies for general use in medicine, but that hasn’t stopped doctors in Colorado from providing them anyway. Chris Centeno and John Schultz have boldly formed Regenerative Sciences Inc. in Broomfield, Colorado. RSI provides its patients with the Regenexx procedure, an adult stem cell transplant that uses your own cells (autologous) to treat joint injuries and bone damage. There’s no surgery needed. A needle extracts bone marrow, RSI isolates the stem cells and cultures them in your own blood, and then these cells are injected into the area where they are needed. They’ve treated 348+ patients with 800+ injections and show no signs of slowing down. According to RSI’s own surveys, 89% of their knee patients showed marked improvement, as did 75% of their hip patients! Within months some patients can walk or run in ways they haven’t been able to in years. We’ve seen these kinds of results from stem cell treatments before, but only in horses and dogs. That’s because human stem cell therapies like this one aren’t approved by the FDA. How can Centeno and Schultz flaunt the lack of federal approval? They claim that Regenexx is solely used as a part of their medical practice, only within the state of Colorado, and as such is no more regulated by the FDA than it would be by the FAA or the Department of Motor Vehicles. I had a chance to talk with Dr. Centeno over the phone and learn more about Regenexx and RSI. For hundreds of patients, he and his team are providing a remarkable hope. They’ve brought lab-cultured medical stem cell therapies to the US. Finally.



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


    A severely damaged knee healed to a remarkable degree. Must be stem cells. RSI is offering adult stem cell therapies in the US. That's an important first, but what will happen without FDA approval?

    read...

    http://singularityhub.com/2010/03/09...erapies-video/

  2. #2
    Manouli, this is good post; I'd like to see what Wise says about it. I know it's not spinal oriented, but many of us have or may have bone or other p[roblems whan our turn comes.

    T.J.

  3. #3
    yea I would like to hear more about this myself. How are some people able to do this. According to the other thread this would lead to the destruction of careers and no one would accept the results and the practitioners would be hung... Strangely enough the results seem to be positive and no one says mumm.

    I'm sure theres more to it. so I guess judgement should be held...

  4. #4
    Quote Originally Posted by Eric.S View Post
    yea I would like to hear more about this myself. How are some people able to do this. According to the other thread this would lead to the destruction of careers and no one would accept the results and the practitioners would be hung... Strangely enough the results seem to be positive and no one says mumm.

    I'm sure theres more to it. so I guess judgement should be held...
    I have already posted on this before. These guys are taking advantage of a loophole in the FDA regulations right now that allows doctors to transplant a patient's own cells into him/herself. This is exactly what is being done by X-cells in Germany, where the clinic is providing a service where they remove cells from the bone marrow, give the cells to the patient, and the patient then goes to some doctor who transplants it. Because this is giving the same cells to the same person, it is not regulated by the US or EU FDA. This is not career-threatening or anything like that.

    The problem with X-cells is that they have zero interest in doing a clinical trial. If you search on this site, you will find a doctor by the name of Kleinboesm, who was actively recruiting people from this site to pay his company to extract the cells and then go to Turkey or one of the former Soviet countries to get the cells transplanted. This was perhaps 5-6 years ago. He has now set up X-cells. They are making a lot of money. I know several people from this site that have gone. I don't think that anybody has recovered much function but this is the problem with not having a clinical trial. All you get are rumors and conjectures. You have no hard data.

    This has been going on for the last 6-8 years with no gain of knowledge for anybody and a lot of people wasting their time and money, as well as emotions trekking to Germany for this unproven therapy. Is this what you want? If this particular group in Colorado does what X-call does and that is sell people their own cells without doing anything to show that the treatment is safe and effective, the FDA should step in and shut them down. If the group is interested and committed to doing proper clinical trials, I applaud. But, I think that the group is interested in making money from an unproven therapy and they don't seem to have any interest in doing clinical trials.

    Wise.
    Last edited by Wise Young; 04-07-2010 at 06:43 PM.

  5. #5
    Super Moderator Sue Pendleton's Avatar
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    Considering the uses that they are talking about is this so much different than what atheletes for years received for injuries. It didn't make the news until civilians were getting their own platelets reinjected in heel cords and knee joints.

    As for clinical trials... They take too long. They cost way too much. And they are used to prove what the manufacturerss will make money from not necessarily what is best for human overall health. IMHO. So if a company or doctor has a ton of excess bucks to toss around on rarer conditions and is altruistic to an amazing degree; clinical trials are nice when the results show up 15 years later.

    I was wondering why the Germans were allowing this procedure in Dusseldorf and it's obviously because it causes no harm and may help.
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

  6. #6
    Quote Originally Posted by Wise Young View Post
    I have already posted on this before. These guys are taking advantage of a loophole in the FDA regulations right now that allows doctors to transplant a patient's own cells into him/herself. This is exactly what is being done by X-cells in Germany, where the clinic is providing a service where they remove cells from the bone marrow, give the cells to the patient, and the patient then goes to some doctor who transplants it. Because this is giving the same cells to the same person, it is not regulated by the US or EU FDA. This is not career-threatening or anything like that.

    The problem with X-cells is that they have zero interest in doing a clinical trial. If you search on this site, you will find a doctor by the name of Kleinboesm, who was actively recruiting people from this site to pay his company to extract the cells and then go to Turkey or one of the former Soviet countries to get the cells transplanted. This was perhaps 5-6 years ago. He has now set up X-cells. They are making a lot of money. I know several people from this site that have gone. I don't think that anybody has recovered much function but this is the problem with not having a clinical trial. All you get are rumors and conjectures. You have no hard data.

    This has been going on for the last 6-8 years with no gain of knowledge for anybody and a lot of people wasting their time and money, as well as emotions trekking to Germany for this unproven therapy. Is this what you want? If this particular group in Colorado does what X-call does and that is sell people their own cells without doing anything to show that the treatment is safe and effective, the FDA should step in and shut them down. If the group is interested and committed to doing proper clinical trials, I applaud. But, I think that the group is interested in making money from an unproven therapy and they don't seem to have any interest in doing clinical trials.

    Wise.
    To be honest as selfish as it is I'm interested in getting better. But I do understand your point. I mean your charging people and making money, the least you can do is collect some data to help along the science not to mention help validate yourself. I have know qualms with that opinion...

    Dr. Young can I ask you what you think about Dr. Luis Geffner? I believe he as published some of his results. I they were actually recorded by researchers from california and published. Have you read his results? Are you skeptical?

  7. #7
    Quote Originally Posted by Sue Pendleton View Post
    Considering the uses that they are talking about is this so much different than what atheletes for years received for injuries. It didn't make the news until civilians were getting their own platelets reinjected in heel cords and knee joints.

    As for clinical trials... They take too long. They cost way too much. And they are used to prove what the manufacturerss will make money from not necessarily what is best for human overall health. IMHO. So if a company or doctor has a ton of excess bucks to toss around on rarer conditions and is altruistic to an amazing degree; clinical trials are nice when the results show up 15 years later.

    I was wondering why the Germans were allowing this procedure in Dusseldorf and it's obviously because it causes no harm and may help.
    I believe that X-cells is in Cologne. I know several prominent German doctors who are very upset by what X-cell is doing. Last fall, I believe that they issued a press release indicating how many patients they have treated and some claim of efficacy. To my knowledge, it has not been published except by newspapers. They are obviously making enough money to have a very nice looking facility and website.

    One of the reasons why clinical trials are so slow is because they are being carried out by one or two centers with shoestring budgets. It often takes quite a lot of time to raise the money and to make sure that the therapy is ready to go. I know this is the case for ChinaSCINet where we have slipped behind several times due to lack of money. When you don't have money, you have to make decisions to choose cheaper routes.

    Your final point concerning company supported trials is true but thankfully is becoming less true as companies such as Acorda are showing the money can be made. A lot of companies are beginning to dip their toes into the water. However, a lot of people probably don't realize that competition within companies for clinical trial funds is very tough in the big pharma companies, perhaps tougher than it takes to get an NIH-funded clinic trial.

    Wise.

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    Work out weekly with an SCI 20 years post injury person who is 6 months post X-cells treatment. No noticeable changes thus far from my vantage point. The person states that there have been no noticeable changes as well.

  9. #9
    As for clinical trials... They take too long. They cost way too much. And they are used to prove what the manufacturerss will make money from not necessarily what is best for human overall health. IMHO.
    Clinical trials are slow and costly BECAUSE they are focused on determining if it is "best for human overall health". That is the sole purpose of a phase 1 trial.

    If the results from this group are so good, why have they not published them? It doesn't take a clinical trial to submit a paper to Stem Cell Research documenting the methods and results. Because they have not is a huge warning flag that things are not so good as they claim, and they know it.

  10. #10
    Super Moderator Sue Pendleton's Avatar
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    I believe that NIH funded clinical trials might be possible if one thing happens: patients are put in charge of what is funded. NINDS funds studies on how to lower cholesterol counts in the SCI'd. Do you care what yours is compared to walking which would then put us under the studies for ABs with high cholesterol. There are a ton of bucks that go to studying the psychology of paralysis. Umm, when will they publish that it seems most paralyzed people just want to be whole again? Or would that kill off what seems to be a huge career field in VOC Rehab for quads.

    Head to the clinical trials site and look at what is currently studied concerning paralysis. Very little goes to physical recovery versus side issues.

    Phase 1's are not for efficacy but for safety. If they were for improving health we could cut out the phase 2s and go straight to phase 3's.
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

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