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Thread: Stem Cell Therapy in Panama?

  1. #1

    Stem Cell Therapy in Panama?

    A carecure member recently wrote the following as a private message to me and I thought that others may want to see the answer the I wrote:
    hello doctor, im a t5-t6 incomplete para. i was wondering if you ever heard of the stem cell therapy offered in panama at www.cellmedicine.com . if you have, what are your views on it. i know im probably like everyone else here looking to walk and get back on there feet and are just looking for a answer. but if you have heard of them and there methods i would liek to know your opinion. 6 years after my injury i still get confused on information given. also do you think its possible to regain function 3 years after injury, because i keep reading a lot of post that 1-3 years is the time frame of recovery. i do realize you probably get hundreds of questions a day but hopefully you will get to mine. also if you know of any clinical trials or therapies being held in the states especially in new jersey since i reside here. thank you again doctor for your time. hope to hear from you soon.
    Thanks for your question. Because this is similar to many other questions that I get every day, I decided to post my answer in the Cure Forum. I left your name out because I was not sure that you wanted to be identified. If you would like you can post and identify yourself. The web site www.cellmedicine.com apparently is being run by a clinic in Panama City. On the web site, they advertise themselves as a cGTP certified facility supported by the Ministry of Health in Panama and provides adult stem cell therapies for patients who are willing to pay. Whenever one sees a web site like this, two questions arise. First, what therapies are they offering? Second, are the therapies beneficial? Third, what are the risks of such therapies? Fourth, is this is a good place to get such therapies. Let me try to answer these questions in order to provide a template for people to use whenever they encounter any advertised clinic.

    1. What is the therapy that they are offering? A lot of clinics don't describe the therapy, its source, and how they get the cells. if so, please be careful. Just saying that the cells are stem cells is not good enough.
      • What kind of stem cells are they? The web site for the clinic says that the "stem cells are derived from the patient's own blood, bone marrow and/or fat."
      • How do they get the cells? Presumably they will collect the cells from the person and then take a few days to process them.
      • How do they ensure the quality of the cells? The web site says, "All cells used in treatments are processed in accordance with Current Good Tissue Practices (cGTP) in a state-of-the-art laboratory that is fully licensed and certified." If true, these are good signs.

    2. Are the therapies they offer beneficial?
      • Have stem cells from these sources shown to be beneficial? While there have been some reports that peripheral blood, fat, and bone marrow contain hematopoietic stem cells and even multipotent stem cells that can make neurons, the details really matter. Most of these stem cells do not behave like stem cells unless they enter into a niche. In other words, adult stem cells are very tightly regulated in their stem cell behavior and they can only make other kind of cells when they enter into a relationship with a group of other cells (called a niche). The spinal cord may not have a "niche" that allows any of these cells to behave like stem cells. On the other hand, several of these so-called stem cells are not being used for their ability to make many different kinds of cells but rather because of two qualities of the cells. First, mesenchymal stem cells from bone marrow have been reported to have anti-inflammatory or anti-immune effects. A clinical trial recently showed that mesenchymal stem cells may be useful to reduce graft-versus-host-disease. Second, many adult stem cells also secrete growth factors and these factors may protect or stimulate other cells to growth. The question is whether any adult stem cells has been reported to be beneficial in spinal cord injury. Yes, indeed, many studies have reported that adult stem cells are beneficial in animal spinal cord injury models.
      • Are the cells being given in the best way possible? Most of these studies involve transplanting the cells directly into the spinal cord at or around the injury site. Studies reporting that the cells can "home" into the spinal cord injury site when given intravenously or intrathecally are not yet convincing.
    3. What are the risks?. Be very careful of places that tell you the treatment has no risk. All treatments and all surgery has some risk. While it is true that autologous cells (one's own cells) that are minimally manipulated (i.e. not grown or genetically manipulated) tend to be relatively safe, there is no such thing as absolute safety. The more the cells are manipulated, the more likely that there will be some safety problem.
    4. Is this a good place for the therapy?. The web site indicates that many of the doctors are trained in the United States and the facilities are certified to be cGTP and GCP compliant. These are rigorous industry standards that are often used to assure the high quality of products. By the way, because a place says that they are cGTP and GCP compliant or certified, this does not necessarily mean that they are. This place sounds like a reasonable place


    Many people believe that it is very difficult to do clinical trials in the United States. This is not true. Getting clinical trials approved in the United States is often easier than in other countries (such as China). The FDA approves clinical trials in the United States. FDA approved clinical trials usually will not allow doctors to charge patients for experimental (unproven) therapies. One exception is autologous cell transplants, even though it may be experimental. The FDA does not regulate surgery or medical procedures. What they regulate medical products and the claims of manufacturers of the products. So, from the federal regulatory point of view, surgeons can take cells or tissues from one part of the body and transfer it to another part without FDA approval and can still charge patients for the procedure. However, because it is experimental, the surgeons must get the permission of their institutional review board (IRB) to approve the procedure.

    Hospitals have not begun in the United States to charge patients for autologous transplants in part because charging patients for experimental therapies is strongly discouraged by the FDA. While autologous transplants of minimally manipulated cells may not be regulated by the FDA, it is nevertheless considered experimental and approval of institutional review board and the FDA is expected. Therefore, charging patients for unproven experimental therapies is unlikely to be approved and will have to be done outside of the clinical trial setting or done overseas in countries where regulations concerning such transplants are lax, such as Panama.

    In summary, I think that this institution in Panama is practicing experimental medicine and charging patients for the treatments. However, if what they say in the web site is true, i.e. they have a cGCP facility preparing all the cells and their doctors are U.S.-trained and certified, this suggests that they are following international standards for sterility and cell quality, as well as surgery and care of patients. Finally, regarding clinical trials in New Jersey, you should come over to a Friday Open House at the Keck Center in Piscataway. The Open House occurs on the first Friday of every month. People start coming at 5 pm, get a tour of the lab, and see a video. I then present a summary update of the field and then talk about the latest in all the clinical trials.

    Wise.
    Last edited by Wise Young; 09-30-2010 at 03:31 PM.

  2. #2
    DR.WISE
    OR ANY ONE ELSE CAN YOU PUT IT ON YOU TUBE . OR CAN IT BE VIEWED . OR HAS ANY ONE TRIED THIS BE FOUR



    Finally, regarding clinical trials in New Jersey, you should come over to a Friday Open House at the Keck Center in Piscataway. The Open House occurs on the first Friday of every month. People start coming at 5 pm, get a tour of the lab, and see a video. I then present a summary update of the field and then talk about the latest in all the clinical
    AS I SIT HERE IN MY CHAIR . I LOOK OUT UPON THE GROUND .I WONDER WILL I EVER GET UP AND WALK A ROUND ??


    http://justadollarplease.org

  3. #3
    Quote Originally Posted by Wise Young View Post
    A carecure member recently wrote the following as a private message to me and I thought that others may want to see the answer the I wrote:


    Thanks for your question. Because this is similar to many other questions that I get every day, I decided to post my answer in the Cure Forum. I left your name out because I was not sure that you wanted to be identified. If you would like you can post and identify yourself. The web site www.cellmedicine.com apparently is being run by a clinic in Panama City. On the web site, they advertise themselves as a cGTP certified facility supported by the Ministry of Health in Panama and provides adult stem cell therapies for patients who are willing to pay. Whenever one sees a web site like this, two questions arise. First, what therapies are they offering? Second, are the therapies beneficial? Third, what are the risks of such therapies? Fourth, is this is a good place to get such therapies. Let me try to answer these questions in order to provide a template for people to use whenever they encounter any advertised clinic.

    1. What is the therapy that they are offering? A lot of clinics don't describe the therapy, its source, and how they get the cells. if so, please be careful. Just saying that the cells are stem cells is not good enough.
      • What kind of stem cells are they? The web site for the clinic says that the "stem cells are derived from the patient's own blood, bone marrow and/or fat."
      • How do they get the cells? Presumably they will collect the cells from the person and then take a few days to process them.
      • How do they ensure the quality of the cells? The web site says, "All cells used in treatments are processed in accordance with Current Good Tissue Practices (cGTP) in a state-of-the-art laboratory that is fully licensed and certified." If true, these are good signs.
    2. Are the therapies they offer beneficial?
      • Have stem cells from these sources shown to be beneficial? While there have been some reports that peripheral blood, fat, and bone marrow contain hematopoietic stem cells and even multipotent stem cells that can make neurons, the details really matter. Most of these stem cells do not behave like stem cells unless they enter into a niche. In other words, adult stem cells are very tightly regulated in their stem cell behavior and they can only make other kind of cells when they enter into a relationship with a group of other cells (called a niche). The spinal cord may not have a "niche" that allows any of these cells to behave like stem cells. On the other hand, several of these so-called stem cells are not being used for their ability to make many different kinds of cells but rather because of two qualities of the cells. First, mesenchymal stem cells from bone marrow have been reported to have anti-inflammatory or anti-immune effects. A clinical trial recently showed that mesenchymal stem cells may be useful to reduce graft-versus-host-disease. Second, many adult stem cells also secrete growth factors and these factors may protect or stimulate other cells to growth. The question is whether any adult stem cells has been reported to be beneficial in spinal cord injury. Yes, indeed, many studies have reported that adult stem cells are beneficial in animal spinal cord injury models.
      • Are the cells being given in the best way possible? Most of these studies involve transplanting the cells directly into the spinal cord at or around the injury site. Studies reporting that the cells can "home" into the spinal cord injury site when given intravenously or intrathecally are not yet convincing.
    3. What are the risks?. Be very careful of places that tell you the treatment has no risk. All treatments and all surgery has some risk. While it is true that autologous cells (one's own cells) that are minimally manipulated (i.e. not grown or genetically manipulated) tend to be relatively safe, there is no such thing as absolute safety. The more the cells are manipulated, the more likely that there will be some safety problem.
    4. Is this a good place for the therapy?. The web site indicates that many of the doctors are trained in the United States and the facilities are certified to be cGTP and GCP compliant. These are rigorous industry standards that are often used to assure the high quality of products. By the way, because a place says that they are cGTP and GCP compliant or certified, this does not necessarily mean that they are. This place sounds like a reasonable place

    Many people believe that it is very difficult to do clinical trials in the United States. This is not true. Getting clinical trials approved in the United States is often easier than in other countries (such as China). The FDA approves clinical trials in the United States. FDA approved clinical trials usually will not allow doctors to charge patients for experimental (unproven) therapies. One exception is autologous cell transplants, even though it may be experimental. The FDA does not regulate surgery or medical procedures. What they regulate medical products and the claims of manufacturers of the products. So, from the federal regulatory point of view, surgeons can take cells or tissues from one part of the body and transfer it to another part without FDA approval and can still charge patients for the procedure. However, because it is experimental, the surgeons must get the permission of their institutional review board (IRB) to approve the procedure.

    Hospitals have not begun in the United States to charge patients for autologous transplants in part because charging patients for experimental therapies is strongly discouraged by the FDA. While autologous transplants of minimally manipulated cells may not be regulated by the FDA, it is nevertheless considered experimental and approval of institutional review board and the FDA is expected. Therefore, charging patients for unproven experimental therapies is unlikely to be approved and will have to be done outside of the clinical trial setting or done overseas in countries where regulations concerning such transplants are lax, such as Panama.

    In summary, I think that this institution in Panama is practicing experimental medicine and charging patients for the treatments. However, if what they say in the web site is true, i.e. they have a cGCP facility preparing all the cells and their doctors are U.S.-trained and certified, this suggests that they are following international standards for sterility and cell quality, as well as surgery and care of patients. Finally, regarding clinical trials in New Jersey, you should come over to a Friday Open House at the Keck Center in Piscataway. The Open House occurs on the first Friday of every month. People start coming at 5 pm, get a tour of the lab, and see a video. I then present a summary update of the field and then talk about the latest in all the clinical trials.

    Wise.
    You are correct ! Stem Cell Trials in the US are easier than in China ....wish us luck with our submission

  4. #4
    Wise, your explanations are so real for us;how do you find the time to answer us? One thing and one thing only, your trials willl be looked at by us with utmost hope and believeability. Your comments on other trials and research findings are good as we try to seperate the bullshit from the truth. We are waiting for some treatments to affect our lives and we're counting on you.

    keeping on

  5. #5
    DR WISE
    you are right in summary of other clinics . But can i say if this clinic or any other clinic in the world comes up with a cure and it shows improvement and is safe . I know you will say what is safe .But if it shows it works The People that can afford it will get the money and pay for it . They will not care what cells they are .Or what is in them . Or is only me thinking this
    Last edited by skeaman; 12-09-2010 at 11:58 AM.
    AS I SIT HERE IN MY CHAIR . I LOOK OUT UPON THE GROUND .I WONDER WILL I EVER GET UP AND WALK A ROUND ??


    http://justadollarplease.org

  6. #6
    "Yes, indeed, many studies have reported that adult stem cells are beneficial in animal spinal cord injury models."

    Good news! Stem cells harvested from the injured person are less likely to trigger the body's defense mechanism and be rejected.

    Dr. Young, I'd like to read some of these studies. Could you provide the names of some of the leading researchers in this field and the titles of the papers they've written?

    Regards,

    Hop

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