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Thread: Question about treatment in China

  1. #1

    Question about treatment in China

    Dr. Wise Young, first of all I need to thank you for your great job, help and immense involvement in the SCI research. Keep doing what you're doing and I know that soon people like me with SCI will regain more of their lives thanks to you and people like you. I was delighted finding this forum and it's a pleasure having the possibility to communicate with you.


    Is there any news about the phase 3 cord blood mononuclear cells +- lithium clinical trial, like when is it going to start? I hope it's gonna be successful and walking on earth it's going to be achieved which is far more important than walking on the moon.
    http://www.chinascinet.org/downloads...release_en.pdf
    I am a C5-6 1year quad and I would need an advice or opinion about the stem cells transplants that you can get in many specialized clinic in China. While awaiting for the right treatment to come up I've decided to try and go to China to have a stem cell treatment, hopping for a bit of improvement, and of course knowing that many can be dangerous or just a big scam. It's really hard to find a good trustworthy clinic. After looking through many web sites I found a centre in Beijing called The Armed Police General Hospital which for me seems to be ok. They say it went through WHO clinical trial registration, obtained the FDA clinical trial approval and had laboratory with GMP certification of stem cell research and preparation. They deliver the cells via CT guided intraspinal injection which method they invented. I am not sure if the so called treatment is a real approved treatment or is a trial for which they got all the needed approval and registration, which costs a big sum of money.
    Can I get your opinion about this or where else and how should I look for a reliable treatment?

  2. #2
    Senior Member Imight's Avatar
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    Quote Originally Posted by Silvio GS View Post
    Dr. Wise Young, first of all I need to thank you for your great job, help and immense involvement in the SCI research. Keep doing what you're doing and I know that soon people like me with SCI will regain more of their lives thanks to you and people like you. I was delighted finding this forum and it's a pleasure having the possibility to communicate with you.


    Is there any news about the phase 3 cord blood mononuclear cells +- lithium clinical trial, like when is it going to start? I hope it's gonna be successful and walking on earth it's going to be achieved which is far more important than walking on the moon.
    http://www.chinascinet.org/downloads...release_en.pdf
    I am a C5-6 1year quad and I would need an advice or opinion about the stem cells transplants that you can get in many specialized clinic in China. While awaiting for the right treatment to come up I've decided to try and go to China to have a stem cell treatment, hopping for a bit of improvement, and of course knowing that many can be dangerous or just a big scam. It's really hard to find a good trustworthy clinic. After looking through many web sites I found a centre in Beijing called The Armed Police General Hospital which for me seems to be ok. They say it went through WHO clinical trial registration, obtained the FDA clinical trial approval and had laboratory with GMP certification of stem cell research and preparation. They deliver the cells via CT guided intraspinal injection which method they invented. I am not sure if the so called treatment is a real approved treatment or is a trial for which they got all the needed approval and registration, which costs a big sum of money.
    Can I get your opinion about this or where else and how should I look for a reliable treatment?
    Dr. Young updates this thread
    http://sci.rutgers.edu/forum/showthr...Update/page188

    I linked you from most recent post, so just click previous to go backward in time. He answers MANY if not all questions there.

    good luck.

  3. #3
    I'd be careful about going overseas and paying for experimental treatment. If such clinics were having any significant success with SCI patients then they'd be shouting about it from the rooftops and we'd soon get to know about it. But they are not. These places don't even release any proper data.

    That's not to say stem cells aren't the answer for us however at the moment there is still a hell of a lot of work needed before we are at treatment stage. Anyone who claims otherwise is a snake oil saleman imo.

  4. #4
    Quote Originally Posted by Silvio GS View Post
    A.S. I am a bit behind with the news this being my first post and I'm sorry if my questions are inappropriate.

    Dr. Wise Young, first of all I need to thank you for your great job, help and immense involvement in the SCI research. Keep doing what you're doing and I know that soon people like me with SCI will regain more of their lives thanks to you and people like you. I was delighted finding this forum and it's a pleasure having the possibility to communicate with you.


    Is there any news about the phase 3 cord blood mononuclear cells +- lithium clinical trial, like when is it going to start? I hope it's gonna be successful and walking on earth it's going to be achieved which is far more important than walking on the moon.
    I am a C5-6 complete 1year quad and I would need an advice or opinion about the stem cells transplants that you can get in many specialized clinic in China. While awaiting for the right treatment to come up I've decided to try and go to China to have a stem cell treatment, hopping for a bit of improvement, and of course knowing that many can be dangerous or just a big scam. It's really hard to find a good trustworthy clinic. After looking through many web sites I found a centre in Beijing called The Armed Police General Hospital which for me seems to be ok. They say it went through WHO clinical trial registration, obtained the FDA clinical trial approval and had laboratory with GMP certification of stem cell research and preparation. They deliver the cells via CT guided intraspinal injection which method they invented. I am not sure if the so called treatment is a real approved treatment or is a trial for which they got all the needed approval and registration, for which they ask a big sum of money.
    Can I get your opinion about this or where else and how should I look for a reliable possible stem cell treatment? Thank you very much in advance.
    Dear Silvio GS,

    I am surprised to hear that the Armed Police General Hospital has "obtained FDA clinical trial approval". I assume that they are referring to the China Food and Drug Administration (cFDA). You used the post tense verb "had" when referring to "GMP certification of stem cell research and preparation", suggesting that they do not currently have such certification. In any case, I am pretty certain that they do not have US FDA approval of trials and I am certain the cFDA has not approved of any cellular transplant therapy in China.

    I just met a neurosurgeon from the Armed Police General Hospital group at the International Association for Neurorestorology Symposium (IANR) held in Mumbai last week. To my knowledge, they are doing autologous bone marrow cell transplants. They are doing this through loopholes in regulations that allow transplants of autologous (self) cells, fetal cells, and umbilical cord blood cells. These loopholes are how doctors have been justifying charging patients for transplanting fetal olfactory ensheathing glial cells (Hongyun Huang), umbilical cord blood cells (Beike) into patients in China, autologous bone marrow stem cells (Armed Police General Hospital).

    The cFDA may be closing some of these loopholes. The cFDA is supposed to be announcing new guidelines soon and there is speculation that these new guidelines will address autologous bone marrow, fat-derived stem cells, fetal olfactory ensheathing glial cells, and umbilical cord blood cells. Last year, they announced stringent new regulations concerning clinical trials for cellular therapy. The first step in the regulation is GMP certification of the facilities used to prepare the cells. The second is the requirement for IND (initial new drug/device/cell) clinical trial application for all non-approved therapies. The third is the requirement for BLA (biological license application) for all cell therapies before approval.

    Because the cFDA has not yet released their regulations for cell therapies, I am skeptical that the hospital has cFDA approval for GTP (Good Tissue Practice) or GMP (Good Manufacturing Practice) status for their cell preparation facilities. It may be possible that they may have approval from Military Ministry of Health, which is a separate regulatory agency altogether, for clinical trial. However, if any hospital is charging you for the therapy, it is not likely to be part of a cFDA approved "clinical trial" since hospitals are not supposed to charge patents to be part of clinical trials unless they have "compassionate use" approval, which I did not know was something that the cFDA is giving out.

    Regarding our clinical trial of umbilical cord blood and lithium, we are in the processing of transferring technology to China. In informal meetings that we have held with the Ministry of Health last year, they told us that we must process the cells in GMP facilities in China. We are transferring technology to three centers at major universities in China to do the cell processing and have trained people in these centers to do process the cells according the U.S. standards. After we have validated these centers, we will apply to the cFDA for the clinical trial IND. I hesitate to predict how long this will take since nobody has much experience with the new regulations yet.

    Regarding where else you may get effective sten cell therapies, there is no proven cell therapy for spinal cord injury and certainly no such "approved" cell therapy in the world. Some clinics and doctors are offering cellular therapies under legal loopholes that allow autologous cells, fetal cells, or umbilical cord blood cells to be given without regulation. For example, in India, China, Jordan, Panama, Costa Rica, and some former Soviet countries, you can get intrathecally administered autologous bone marrow stromal cells, fat-derived mesenchymal stem cells, fetal olfactory ensheathing glial cells, various fetal cells, and intrathecal or intravenous umbilical cord blood cells. However, none of these therapies have been proven to be effective. In my opinion, if you go to any of these places and pay for unproven therapies, you are treating your emotions and not your spinal cord.

    What are the drawbacks of receiving therapies at such clinics? First, the therapies are probably ineffective for following reasons. For example, most fetal cell transplants are not immune matched and will be rejected by the recipient's immune system. Autologous cells would not be rejected but there is no credible evidence that these cells work when applied intrathecally or intravenously. Second, the risk of the treatment is not known. Many laboratories that prepare cells for transplantation are not certified by any regulatory authority. Third, the mechanisms of action of the cellular therapies are not well understood.

    Having been transplanted with cells may also preclude you from other trials. In our phase III trial, we are still considering how long we should wait for patients who have received another cell transplant before we will accept the patient in the phase III trial. In the phase I/II trials, we set a period of 6 months. However, in the upcoming Phase III trial, we may decide to set a period of 12 months between the last transplant and participating in the phase III. This is because of our latest Phase II results indicating that it takes at least one year or more before regenerating fibers and locomotor recovery occurs after cell transplantation. We want to make sure that there is no recovery due to the previous transplant.

    In summary, if I were you, I would wait until more reliable and credible information is available concerning efficacy of cell transplant clinical trials. At the present, insufficient data support approval of human umbilical cord blood therapy or any kind of cells for chronic spinal cord injury. In the coming several years, I am sure that additional evidence will be published to allow a more rational choice of therapies and trials.

    Wise.

  5. #5
    Dear Mr. Wise,
    I'm pleased to get your reply to my enquire. Thank you! I have it clearer now and a bit disappointed that my fears were confirmed... but looking forward with confidence for a more reliable therapy to come.


    And about the trials, I really want to get into one, but it seems impossible. I've been emailing so many trials I found on Google, where my eligibility criteria would suit, even to the third phase of the ChinaSCiNet trial which would make my dream come true participate...and unfortunately no response. The thing is I live in Ireland where are no trials and I imagine that at the trials they get local people from the same country. Anyways traveling wouldn't be an issue for me. If I could get some help regarding SCI trials, this is my email: gabrielsilviustefan@yahoo.com.
    Thank you very much Mr. Wise.
    Big respect.

  6. #6
    Silvio, check clinicaltrials.gov
    Simply googling trials will not get you very far.

  7. #7
    Tomsonite, clinicaltrials.gov doesnt get you anywhere either, emailed all of the trials that were recruiting supposedly multiple times without an answer. Silvio I have asked the same question on here numerous times also without much answers. Seems there is no way to get into the trials that are actually legit, good luck

  8. #8
    There are very few or no active clinical trials for chronic spinal cord injury at the present. Many of the trials listed on Clinicaltrials.gov have not yet started their recruitment phase or are past their recruitment phase. To my knowledge, none of the clinical trials are actively recruiting patients at the present. I have heard that both Neuralstem and Stem Cells Inc. have obtained IND permissions to do their trials but I don't know whether they are actively recruiting yet. So, please don't blame clinicaltrials.gov for the fact that there are few active trials for chronic spinal cord injury trials. ChinaSCINet, SCINetIndia, SCINetNorway, and SCINetUSA are planning a phase III trial but have not yet obtained permission for the trials and will not be actively recruiting until permission and funding have been attained. I know that it is a very frustrating time for everybody waiting for trials but this has been a problem for a long time and some of us have been working hard to try to correct this problem.

    Wise.

  9. #9
    Dear Mr. Wise as all those who have a spinal injury that we can look forward to finding a cure x and let us move back to being normal. I ask itself there is no age limit or something?

  10. #10
    Quote Originally Posted by Wise Young View Post
    There are very few or no active clinical trials for chronic spinal cord injury at the present. Many of the trials listed on Clinicaltrials.gov have not yet started their recruitment phase or are past their recruitment phase. To my knowledge, none of the clinical trials are actively recruiting patients at the present. I have heard that both Neuralstem and Stem Cells Inc. have obtained IND permissions to do their trials but I don't know whether they are actively recruiting yet. So, please don't blame clinicaltrials.gov for the fact that there are few active trials for chronic spinal cord injury trials. ChinaSCINet, SCINetIndia, SCINetNorway, and SCINetUSA are planning a phase III trial but have not yet obtained permission for the trials and will not be actively recruiting until permission and funding have been attained. I know that it is a very frustrating time for everybody waiting for trials but this has been a problem for a long time and some of us have been working hard to try to correct this problem.

    Wise.
    Dear Professor Wise,

    First of all, as a quad, I wish to thank you for your outstanding involvement in finding a cure for us and the fabulous hope your work and research bring to our entire community.
    On your last post, you mention a lack of funding as a source of delay for the phase III trial.
    Could you here tell us how much you need now to feel comfortable and secure with your level of funding?

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