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Thread: ChinaSCINet Update

  1. #521
    Quote Originally Posted by jcalix View Post
    Dear Wise why in this trials don't include penetration SCI such as gun-shoot, knife-cutting or SCI caused by non-traumatic condition?, thank you

    Regards

    Jose
    Jose,

    In the current ChinaSCINet phase 2 trial, patients with gunshot and other penetrating wounds of the spinal cord are not being excluded. We do exclude patients who have lesions that extend more than 2 segments (this is because we are injecting into the injury edges and don't want to do a laminectomy that is wider that 3 segments). Depending on the results of the phase 2 trial, penetrating causes of spinal cord injury may or may not be excluded from the phase 3 trial.

    Wise.

  2. #522
    Quote Originally Posted by Jawaid View Post
    Dear Wise with what combination you will be going with your upcoming trial for lumbosacral injuries? Are you also thinking for chondroitinase to be included in ur coming trial?
    Quote Originally Posted by lunasicc42
    Wise, I would like to add to this string of questions... Presumably the china trials are showing that the procedure is safe, so is there a reason that when the data is given to the US FDA you'd have to have the same inclusion criteria and couldn't move to C4,although safety has already been shown in china?
    Jawaid and lunasicc42,

    At the present, the lumbosacral studies are preclinical, i.e. being done in animals. I don't know enough yet to predict any therapeutic effect or plan. The data is not likely to be available for another year (or more). Chronic animal spinal cord injury experiments take a long time and a huge amount of work.

    We are significantly behind our schedule for both the Hong Kong and Kunming trials. Of 40 planned subjects (20 in Hong Kong and 20 in Kunming), we have only 8 in Hong Kong and 18 in Kunming. Only several patients have reached their one year post-transplantation time and only two patients have received the highest dose with MP and lithium.

    I met with the investigators and we have agreed on a plan to complete recruitment for the trial by the end of March. In Hong Kong, we are applying to regulatory authorities for permission to study only four more patients. If they agree, we will do transplant 2 patients in Kunming and 4 in Hong Kong by the end of March.

    This unfortunately sets our schedule back. We will not be able to apply for an IND in the US until May or later. I had not anticipated that it would take so long to recruit patients for Hong Kong and that it would take us more than a year to get the import license for the cells into China. However, the trials themselves are going well. The investigators are collecting the data.

    Wise.
    Last edited by Wise Young; 01-21-2012 at 06:58 AM.

  3. #523
    dear professor Young you said to going to make come patient of china has Hong-Kong for finish clinical trial in HK. and after madam poon said in a post would make for ten patient has Hong-Kong and ten the other one has kunming why to have still changed

    sorry for all the questions but this is really interesting

    thank you

  4. #524
    Quote Originally Posted by Wise Young View Post
    Jawaid and lunasicc42,

    At the present, the lumbosacral studies are preclinical, i.e. being done in animals. I don't know enough yet to predict any therapeutic effect or plan. The data is not likely to be available for another year (or more). Chronic animal spinal cord injury experiments take a long time and a huge amount of work.

    We are significantly behind our schedule for both the Hong Kong and Kunming trials. Of 40 planned subjects (20 in Hong Kong and 20 in Kunming), we have only 8 in Hong Kong and 18 in Kunming. Only several patients have reached their one year post-transplantation time and only two patients have received the highest dose with MP and lithium.

    I met with the investigators and we have agreed on a plan to complete recruitment for the trial by the end of March. In Hong Kong, we are applying to regulatory authorities for permission to study only four more patients. If they agree, we will do transplant 2 patients in Kunming and 4 in Hong Kong by the end of March.

    This unfortunately sets our schedule back. We will not be able to apply for an IND in the US until May or later. I had not anticipated that it would take so long to recruit patients for Hong Kong and that it would take us more than a year to get the import license for the cells into China. However, the trials themselves are going well. The investigators are collecting the data.

    Wise.
    stuff happens. we all know this very well. the good news is that the trial is still going on.
    when do you expect to be able to share any data with us?

  5. #525
    Barrington, the thing that stand out above everything else is: the trials in China have been delayed again. From Dr Young's update, it appears that lack of patients is the problem. Now, if we can't get enough patients in China, we're in trouble. At the very least we are in trouble with getting results in many of our lifetimes. The start of trials in the USA are out further and further, no matter who starts them. The Chase trials are only in discussion stages . The application and beging of phase 1 trials are years away. Stem Cell INc are in phase 1 trials in Switzerland. Wise Young's trials in China are dealyed. The beginning of trials in the USA were to begin in 1st quarteer of 2012. We have to be honest with ourselaves and the answer is quite clear. anthony

    Anthony

  6. #526
    Quote Originally Posted by fti View Post
    dear professor Young you said to going to make come patient of china has Hong-Kong for finish clinical trial in HK. and after madam poon said in a post would make for ten patient has Hong-Kong and ten the other one has kunming why to have still changed

    sorry for all the questions but this is really interesting

    thank you
    fti,

    Last year, I reported to the board of the Hong Kong SCI Fund and asked them to raise an additional funds to support adding 10 patients from Mainland China. Our clinical trial is based on subjects who have valid Hong Kong ID's, which allows hospital expenses to be covered by the government. Patients who are not Hong Kong residents would not be covered. The cost of surgery, hospitalization, and lodging of the patients would be substantial.

    We also have to ensure that the patients come back for followup studies and the patients have housing in Hong Kong. How do we cover travel and housing of patients to be screened for the study and how we would pay for patients who travel to Hong Kong and stay 2 months for the initial part of the study and then the cost of coming back for their 6 and 12 month followup exams.

    So, we have discussed these issues extensively, including opening up the trial to people from all over the world. In the end, we have decided that the original goal of recruiting a total of 20 patients from Hong Kong is unlikely to be achievable within the coming 3 months. However, the team felt confident that they can recruit another four patients.

    I suggested to the group that they consider just doing the highest dose with MP and lithium, since Kunming has shown the safety of the 16 ┬Áliter injections and methylprednisolone treatment. They agreed to apply to their IRB (institutional Review Board) for permission to do this. In the meantime, Kunming needs to do two more patients in the highest dose group plus MP and lithium.

    This way, we will achieve our objective of having 8 patients in the highest cell dose group with MP and lithium. If this turns out to be safe, we will propose this protocol for the U.S. trial. But, we have to wait for the data. This unfortunately delays our U.S. protocol. However, we are proceeding with the development of the Norway protocol.

    There are always obstacles and unexpected developments in clinical trials. When we started this trial two years ago, we did not have all the money raised and we were uncertain whether the treatment protocol is safe. Now, 39 transplantations later (Kungming has also done 13 transplants into subacute spinal cord injuries besides the 26 transplants into chronic spinal cord injury), we have raised the funds for the phase 2 trial in Hong Kong an Kunming and the trials are going ahead. We must complete the data collection to ensure that the combination of the cell transplants, MP, and lithium are safe.

    We need to see a trend for improvement in the patients before we can proceed to phase 3 trials. Yes, some patients are getting some recovery but we have to confirm these on 6-week, 6-month, and 12-month followup examinations. Finally, of course, we are raising the money for the U.S. trials, preparing for EMA (European) and Norwegian approval of the protocols, and preparing to apply to the U.S. FDA.

    Wise.
    Last edited by Wise Young; 01-21-2012 at 02:07 PM. Reason: minor grammar correction

  7. #527
    All I know is that I am looking forward to a possibility .

  8. #528
    Quote Originally Posted by keeping on View Post
    Barrington, the thing that stand out above everything else is: the trials in China have been delayed again. From Dr Young's update, it appears that lack of patients is the problem. Now, if we can't get enough patients in China, we're in trouble. At the very least we are in trouble with getting results in many of our lifetimes. The start of trials in the USA are out further and further, no matter who starts them. The Chase trials are only in discussion stages . The application and beging of phase 1 trials are years away. Stem Cell INc are in phase 1 trials in Switzerland. Wise Young's trials in China are dealyed. The beginning of trials in the USA were to begin in 1st quarteer of 2012. We have to be honest with ourselaves and the answer is quite clear. anthony

    Anthony
    Anthony,

    Lack of patients in China is not a problem; there are plenty of people there who are willing to volunteer. In China, we have had to blaze new trails in almost everything that we have done. This is the first trial of cells imported from the United States in China. It is the first cooperative clinical trial network in China that I know of. They started in Kunming in October 2011 an did 18 patients in 3 months.

    Lack of patients in Hong Kong is a problem because there are relatively few people with spinal cord injury in Hong Kong. I suppose that I could have gotten more patients by hyping the therapy but this is not the way we do things. Trust, credibility, and ethical conduct is essential for ChinaSCINet. This is a partnership with the community.

    Lack of volunteers is likely to be a problem for the world. We may have trouble finding 20 patients for a phase 1/2 trial in Norway, France, or the United States. However, this is one of the reasons why we must have networks with multiple centers. Networks is the only way to get the numbers that we need to show therapeutic efficacy.

    Please, I also want to say that I am very grateful to patients who have volunteered to participate in the clinical trials. In Hong Kong, in particular, where there is cradle-to-grave health care, there is really no reason for people to volunteer for trials. Why not wait until the trials show that the treatment is safe and effective? So, I thank those who have volunteered.

    Finally, I am very grateful to the doctors who have given their time, energy, staff, and funds for the trial. Drs. Waisang Poon and Gilbert Leung of CUHK and HKU respectively are incredibly dedicated to the trial. After having seen them operate and take care of their patients, I know that I would put my spinal cord under their knives. They care and hopefully will cure.

    Wise.
    Last edited by Wise Young; 01-21-2012 at 02:08 PM.

  9. #529
    Dr Wise Young
    I would do anything to get into the Networks , I just wish I knew how .
    TY
    GL

  10. #530
    Senior Member
    Join Date
    May 2005
    Location
    Pakistan
    Posts
    1,177
    Anthony you means chase trials are still few years away? If so then that is really very discouraging for us. We will give up. I was just hoping for chase trial in a year or so

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