Thread: ChinaSCINet Update

  1. #2331
    Quote Originally Posted by Wise Young View Post
    tumbleweeds, I had answered this question regarding participation in the Hong Kong trials. I had answered at the time that we could not accept patients who are not residents of Hong Kong because hospital fees would be charged to such patients. However, this situation varies depending on the trial and funding. Recently, for example, the Hong Kong SCI Fund approved funding for a clinical trial in Kunming that will compare the effects of untethering surgery and no surgery in patients that receive the Kunming intensive locomotor training program for 3-6 months. This trial would not be restricted to Chinese patients. Patients from the U.S., for example, would be able to participate in such a trial, just like Chinese patients. However, of course, patients have to pay for their own travel and expenses of any caregivers who might be traveling with them. I was just in Kunming and they tell me that they would welcome foreign patients. I will comment in a separate post about access of patients to phase II and III trials that we are planning for umbilical cord blood mononuclear cell and lithium clinical.

    Wise.
    Thank you for the update and clarification.


  2. #2332
    Quote Originally Posted by lunasicc42 View Post
    Is it just because I am sci and impatient or has phase 3 been taking abnormally long to get started? I am posing this as a serious question and not trying to sound combative though it may ....genuinely interested
    Is taking a long time, clinical trials are tough, especially when done the right way, and on the other side of the globe. Hang in there, Wise, and the entire team are doing all we possibly can.

  3. #2333
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by Jim View Post
    Is taking a long time, clinical trials are tough, especially when done the right way, and on the other side of the globe. Hang in there, Wise, and the entire team are doing all we possibly can.
    ...good stuff


    I am going to be selfish and ask a selfish question ...as a c456 quad, 11 years post, aisa A with a trach: when am 'I' going to to be able to take part in a chinascinet trial or Scinetusa trial? I will travel if needed and am also able to pay a proper amount
    "That's not smog! It's SMUG!! " - randy marsh, southpark

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  4. #2334
    Quote Originally Posted by Wise Young View Post
    I was just in Kunming and they tell me that they would welcome foreign patients. I will comment in a separate post about access of patients to phase II and III trials that we are planning for umbilical cord blood mononuclear cell and lithium clinical.

    Wise.
    Are you still waiting on that info or the time to tell us about it? I'm slightly confused here because at first it sounds like its just the walking program in Kunming that will accept foreign patients but then the comment after that leads me to believe that foreign patients might be able to go to China for the cells and lithium as well. Thank you for any more info.

  5. #2335
    Barrington314mx, I was talking only about the walking trial, which is funded by the HKSCIFund and would welcome overseas patients. It does not involve umbilical cord blood mononuclear cell transplants or lithium.

    We are working hard on Phase III IND's (clinical trial applications) for umbilical cord blood mononuclear cell transplants and lithium treatment of chronic complete SCI in China, India, Norway, and the United States. Depending on how these applications are reviewed by the respective regulatory agencies (cFDA, DCGI, EMA, FDA) of these countries, we may or may not get approval of these phase III clinical trial applications for trials before 2016.

    In the meanwhile, we have decided to do phase IIb trials in China, India, and the U.S.A.. In China, we have applied for funding from Guangdong Province and it looks like the grant will be approved and the trial will be done in Jinan University in Guangzhou. The regulatory status of umbilical cord blood mononuclear cells is unclear right now in China. They issued new regulations that imposed onerous new requirements for cellular therapies.

    In India, we are organizing a phase IIb trial in Mumbai and Chennai. We have commitments of funds for the trial from a group of families and Apollo Hospital. We still have to apply for permission for these studies but anticipate that approval of phase IIb INDs will be easier and faster than IND's for Phase III trials in India. Moreover, there is a possibility that the DCGI will give conditional market approval if the phase IIb trial is successful. The government of India has adopted a policy similar to Japan.

    We are also talking about doing a phase IIb trial in the United States, if we are able to raise the funds. That trial will be done in New Jersey Medical School in Newark, probably involving 20 subjects. This is still under discussion. All of these trials of course depend on approval of the trials by the regulatory agencies of each country. We hope that these phase IIb trials are more rapidly approved than Phase III trials.

    All of the above has happened in just the last two months and much remains to be done to try to get these trials going before the end of 2015. Accessibility of these trials to overseas patients is unknown. These trials are non-randomized trials that will look at the feasibility of transplanting HLA-matched umbilical cord blood mononuclear and 6-week course of oral lithium, followed by intensive locomotor training.

    The inclusion and exclusion criteria are still being discussed but should be decided by July when we will submit the INDs. I do not know accessibility of these trials to patients from overseas. Patients will not be recruited until after the trials have been approved by the regulatory agencies. The trials will be announced in http://www.clinicaltrials.gov and here on carecure as soon as we get approval and start recruitment.

    The major hurdle is getting approval of the cell processing. In China, the cells will be processed at the Jinan University under contract from Stemcyte. For the India and U.S. trial, the cells will be processed by Stemcyte in San Diego. The source, processing, shipping, testing of cells must be documented in great detail. These Phase IIb trials should provide robust multicenter data confirming the Kunming results and facilitate approval of the phase III trials in the U.S. and Europe

    Wise.
    Last edited by Wise Young; 05-11-2015 at 01:26 AM.

  6. #2336
    Senior Member Moe's Avatar
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    Can someone please tell me whats the difference between phase II, IIb & III? and how many left until its the the market?

  7. #2337
    Senior Member khmorgan's Avatar
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    Quote Originally Posted by Moe View Post
    Can someone please tell me whats the difference between phase II, IIb & III? and how many left until its the the market?
    http://en.wikipedia.org/wiki/Phases_...nical_research

    Phase II studies are sometimes divided into Phase IIA and Phase IIB.

    • Phase IIA is specifically designed to assess dosing requirements (how much drug should be given).
    • Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)).

  8. #2338
    Quote Originally Posted by lunasicc42 View Post
    ...good stuff


    I am going to be selfish and ask a selfish question ...as a c456 quad, 11 years post, aisa A with a trach: when am 'I' going to to be able to take part in a chinascinet trial or Scinetusa trial? I will travel if needed and am also able to pay a proper amount
    The decision of who should be in a trial will be made by the investigators at each center. The protocol stipulates inclusion and exclusion criteria. After that, once the patients meet the criteria, the decision depends on the investigator who has to weigh risk, suitability, likelihood of followup, and other factors in the decision. From the perspective of the trial inclusion and exclusion criteria, it is possible that you may not fit because you may be ASIA B or C, neurological level may be C3 or C4 (the lowest intact level), and the lesion length may extend 2 segments. To date, our trials have specified ASIA A, C5-T11, and lesion length ≤2 segments.

    However, for the phase IIb trials, we are considering expanding the inclusion criteria to ASIA A, B, and C and neurological level of C4 to T11. We have not discussed the possibility of including patients with lesion lengths that are greater than 2 segments. The reason is because it would require a 4 level laminectomy to expose the spinal cord above and below the injury site to transplant the cells. Such a long laminectomy increases the risk of instability and we don't feel that this risk is warranted until it is clear the the treatment is effective. It is not clear that you would qualify for the trials even under the expanded inclusion/exclusion criteria.

    On the other hand, exclusion from the trial does not mean that the treatment will not be beneficial for you. We are planning to apply for compassionate use of the therapy by qualified doctors when the phase III trial is approved. This would mean that if you are able to find a qualified doctor to apply the therapy and locomotor training, that doctor can obtain the cells to apply to you at cost. The cost of the cells will be negotiated by the regulatory agency (e.g. US FDA) with the company. This, however, is not likely to happen until the phase III trial starts, perhaps mid-2016.

    The major question that we are debating now is whether ASIA B and C should be included in the phase IIb. I believe that people who are stable ASIA B and C chronic SCI do not recover very much without therapy and therefore should be candidates for the trial. However, some of the investigators believe (legitimately in my opinion) that the trial would be much more credible if all the subjects were complete, i.e. ASIA A, like it was in our trials to date. Unfortunately, we are finding that relatively few people with chronic SCI are ASIA A.

    Contrary to what is published, we find that many people have anal sensation and motor function below the level of injury, even though they were originally ASIA A. I am using the term ASIA rather than AIS (ASIA Impairment Scale) because people may not recognize AIS. I am suggesting that we should use the opportunity of this phase IIb trial to compare the response of complete and incomplete patients to the treatment. It would be important to know whether or not the therapy improves people with ASIA B and C, in addition to A.

    Before we did our phase I and II trials in Hong Kong and Kunming, we could not have chosen people who are ASIA B or C because doctors were afraid that transplantation of the cells into the spinal cord may cause of the loss of some function. However, so far, we have not observed neurological loss in any of the patients, even though we have transplanted cells into the spinal cord above the injury site (where sensory and motor function are intact). I think our safety data to date justifies the inclusion of ASIA B and C. This is a decision that our investigators must come to a consensus on.

    Wise.
    Last edited by Wise Young; 05-14-2015 at 08:31 AM. Reason: correct typographical errors and to introduce the concept of stratification in trials to compare complete and incomplete

  9. #2339
    Thank you. These terms are just labels.

    In general, phase I trials show safety and feasibility. Phase II trials are intended to identify the optimal dose and outcome measures. Some people use the terms phase IIa and IIb to refer to dose-escalation studies and efficacy studies. The Kunming trial is what would be called a dose-escalation trial and we found no significant effect of dose. The lower doses appear to be effective and the higher doses appear to safe. We have never done intensive walking training of patients outside of Kunming and there is some skepticism that we would be able to do so in a phase III trial. So, the phase IIb trials at Jinan University, India, and United States would help allay that anxiety.

    Phase III trials are pivotal trials that provide the data for regulatory approval. We are trying to get regulatory agencies to approve phase III trials and this may take time. So, while we are waiting the phase III trials to be approved, I thought that we should go ahead and do phase IIb trials (which are intended to confirm our previous data from Kunming). This will help get our phase III trials approved and also tell us if there are any unanticipated problems.

    Please note that the Hong Kong SCI Fund decided to support a clinical trial to determine whether the surgery and walking training are effective. Even though many doctors today will acknowledge that no amount of walking training will enable a person with chronic complete spinal cord injury to walk, the first thing they will say is that intensive training can allow patients to walk. We need to answer this criticism up front. That is why the trial is there. By the way, it is possible that intensive walking training without cell transplant may restore walking, bowel, and bladder function.

    Finally, regarding the U.S. trials, funding is our major obstacle. If we can't raise the funds of the trial or the company (Stemcyte) doesn't make its IPO, we can't go ahead with the trial. It costs $150,000 per subject for the surgery, rehabilitation, and walking training.

    Wise.

    Quote Originally Posted by khmorgan View Post
    http://en.wikipedia.org/wiki/Phases_...nical_research

    Phase II studies are sometimes divided into Phase IIA and Phase IIB.

    • Phase IIA is specifically designed to assess dosing requirements (how much drug should be given).
    • Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)).

  10. #2340
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    Wise still chronic lumbar injury patients not able to participate this trial?
    What plans for starting lumbosacral trials? In 2016 hopefully or still not?

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