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Thread: Clinical Trials

  1. #531
    A member asked for an explanation phase I, II, and III trials. I thought that others might have the same question and therefore decided to post an explanation. By the way, many other places in internet have such definitions but let me describe the trials as it pertains to spinal cord injury.

    A Phase I trial is usually intended to assess the safety and feasibility of an experimental therapy. The definition of phase I has shifted over the years and differs depending the treatment and the conditions. Originally, Phase I trials tested drugs on normal volunteers but I usually refer to phase I spinal cord injury trials as those that test experimental therapies in people with spinal cord injury. Note that there is a special type of Phase I trial, called "first-in-man" (also first-in-human) trials, where a therapy is being tested in humans for the first time. These are usually subjected to more regulatory scrutiny. Phase I trials tend to be open label (i.e. the subjects and the doctors know who is receiving what treatment).

    A Phase II trial is usually intended to determine the optimal dose or outcome for the trial. Note that it is possible to combine Phase I and Phase II trials, called a Phase I/II trial. It is also possible to combine a Phase II and III trials, sometimes called a Phase II/III or a IIb trial. These are trials that are randomized to treatment and control groups with sufficient power (number of subjects to establish statistically significant results) to detect efficacy of therapy.

    A Phase III trial is intended to establish efficacy of the treatment. These trials are usually multicenter, randomized, double-blind, controlled trials that have sufficient numbers of patients to establish efficacy. Usually, two Phase III trials are necessary to lead to U.S. FDA approval of a therapy. These trials can be carried out overseas and in the United States simultaneously.

    There are also Phase IV trials, which are intended to establish the long-term safety of the therapies. These often take place after the treatment has been approved by the regulatory agency.

    Wise.

  2. #532
    Quote Originally Posted by Wise Young View Post
    At the present, we are not planning to do Cethrin until 2014. The reason is because Cethrin still needs to be manufactured for the trial and we are committed to doing the UCBMC±lithium phase III trial in 2013. We must get the data for our current phase II UCBMC±lithium trials to apply for the phase III trials. It takes time to get IND's approved. Mid-2013 start is our goal.

    It is true that if we have the money, we might be able to do parallel trials but that would require substantial organization and more centers than we currently have. I am already writing grants to try to fund phase II trials combining UCBMC, Cethrin, and lithium that can be carried out concurrently with the phase III trial.

    It is not appropriate for each person to raise money for participating in the trial. That would be similar to the person paying to get in trial. There should be no linkage between a person raising money and getting into the trail. If people raise or give money to a clinical trial fund, it should have no influence on whether the person participates in the trial or not.

    Wise.
    I would really like to know where i can register for the UCBMC+lithium phase III trial. It's for my daugther, she is 7 at the moment and I would like to see if she can get into this trial. Please let me know who i should contact about this. PLEASE.

    Best regards,
    Inci
    Mother of Ameli

  3. #533
    Quote Originally Posted by Ameli2005 View Post
    I would really like to know where i can register for the UCBMC+lithium phase III trial. It's for my daugther, she is 7 at the moment and I would like to see if she can get into this trial. Please let me know who i should contact about this. PLEASE.

    Best regards,
    Inci
    Mother of Ameli
    Inci,

    The Phase 3 trial will not start until mid-2013 at the earliest. Recruitment for the trial has not started. It is also only for adults (age 18-64). Your daughter, if she is 8 years old, would be eligible for another trial that we are hoping to start within 2013 at Shriner's Hospital in Philadelphia. That trial (for children ages 8-17) also has not yet started and is not yet recruiting subjects. Please be patient. As soon as details are available for these trials, I will post them both on http://clinicaltrials.gov and on this site (CareCure).

    Wise.

  4. #534
    Thank you for your reply Dr Young.

    You say it is another trial that is coming up for children at Shrinners Philadelphia. Could you explain in what way it is different then the UCBMC+lithium+rehab trial. Is it going to be a phase III trial or a I or II.

    Futher i'll try to be patient .

    Thanks,
    Inci
    mother of Ameli

  5. #535

    Question eligibility??

    Other question.

    If you were to participate in a study, does that rule you out in any other study in the future.

    I can imagine from a scientific point of view that only patient that underwent no other testing are eligible for a study.

    That could mean if you want to participate in a phase 3 study it wouldn't be smart to go somewhere else before that right??

    Hoping for a reply.

    THX,
    Inci

  6. #536
    The time is here, the wait is coming to an end! Get em Wise, I wish I could hand you a blank check sir!

  7. #537
    Quote Originally Posted by Ameli2005 View Post
    Thank you for your reply Dr Young.

    You say it is another trial that is coming up for children at Shrinners Philadelphia. Could you explain in what way it is different then the UCBMC+lithium+rehab trial. Is it going to be a phase III trial or a I or II.

    Futher i'll try to be patient .

    Thanks,
    Inci
    mother of Ameli
    We are thinking of a phase II trial, since it will not have enough patients to establish efficacy. It would tell us whether the treatment can be safely applied to children and whether it has effects similar to adults.

    Wise.

  8. #538
    Quote Originally Posted by Ameli2005 View Post
    Other question.

    If you were to participate in a study, does that rule you out in any other study in the future.

    I can imagine from a scientific point of view that only patient that underwent no other testing are eligible for a study.

    That could mean if you want to participate in a phase 3 study it wouldn't be smart to go somewhere else before that right??

    Hoping for a reply.

    THX,
    Inci
    Inci,

    Much depends on the clinical trial. Certain clinical trials have strict exclusion criteria to rule out participation in previous clinical trials or experimental therapies received overseas. In our trials, because we do not believe that any therapy overseas or previous clinical trial has shown significant improvement to date, our trials will probably exclude people who are participating or were participating (within a year) in a current trial involving an experimental therapy. However, we are planning clinical trials for people who have already participated in our clinical trials.

    Wise.

  9. #539
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    Wise,


    I'm sure my question has been answered at some point before and after reading through quite a few posts, haven't quite found the answer yet. Cutoff level in the umbilical cord/lithium study is C5. Awaiting demonstrations of efficacy, and hopefully eventual phase 3 statistical significance in motor improvement, would any treatment be feasible for higher levels? It's the rationale at this point focused on avoiding safety issues for higher cervical levels?

  10. #540
    Quote Originally Posted by cubsfan View Post
    Wise,


    I'm sure my question has been answered at some point before and after reading through quite a few posts, haven't quite found the answer yet. Cutoff level in the umbilical cord/lithium study is C5. Awaiting demonstrations of efficacy, and hopefully eventual phase 3 statistical significance in motor improvement, would any treatment be feasible for higher levels? It's the rationale at this point focused on avoiding safety issues for higher cervical levels?
    cubsfan,

    Sorry that I didn't see this question earlier. Our current approach to injecting the cells into the spinal cord involves making one injection above the injury site and one below. The phrenic nucleus is located at C3 and part of C4. Our surgeons are concerned with injecting cells into the spinal cord where it may damage the phrenic nucleus and hence compromise respiratory function in patients. For that reason, we limited the subjects in the trial to C5 through T10 inclusive. This decision was made before we started the trials.

    We have now had the experience of injecting cells into the C5 through T11 spinal cord of 41 subjects. Based on this experience, we have seen that none of the subjects had any permanent loss of motor or sensory function in the segment above the injury site. One patient showed a transient loss of sensation but it recovered within 2 weeks. So, we feel more confident that the injections do not damage the spinal cord, at least not in a detectable way within the first 3 months after transplantation.

    If further trials show significant improvements in subjects that have received cell transplants, we are planning to do a clinical trial directed at people with higher cervical spinal cord injuries, i.e. C1-C4. Instead of injecting the cells in the segment above the injury site, we plan to inject the cells into the injury site and just below. I believe that such a trial would be justified if we have evidence that the treatment is beneficial to lower spinal cord injury.

    Wise.

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