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Thread: Anyone here enrolled in the stemcells inc trial?

  1. #1

    Anyone here enrolled in the stemcells inc trial?

    Like the title says, just curios if anyone here is enrolled in the stemcell inc. trial.

  2. #2
    Quote Originally Posted by JohnMarz View Post
    Like the title says, just curios if anyone here is enrolled in the stemcell inc. trial.
    John,

    The trial is described in http://www.clinicaltrials.gov/ct2/show/NCT01321333? but it does not indicate the therapeutic window. When I heard the presentation by the chief medical officer of Stem Cell Inc last February, I remember that he said that they are looking for patients who are at about 6 months after injury. Their inclusion criteria, however, states only "minimum of six weeks post injury for the initiation of screening" and "must be at stable stage of medical recovery after injury".

    Note also that the inclusion criteria requires that subjects have T2-T11 spinal cord injury both by MRI and ASIA criteria. Conus function must be preserved. Exclusion criteria includes any previous participation in gene transfer or cell transplant trial. The latter, for example, would exclude people who had X-cell, Beike Biotech, Geeta Shroff, or Geron therapies.

    I met Armin Curt in Brescia. He is the principal investigators of this trial. Several of the people in wheelchairs at the Brescia meeting talked to him. I respect him and his work a great lot. I am really looking forward to the results of this trial.

    Wise.

  3. #3
    Hi Wise,
    Thanks for replying. I actually saw something you said on another thread about the one year wait in between trials and since you're not doing anything here until 2012 it sparked my interest in this trial again. What do you mean when you refer to therapeutic window? Also would you mind explaining how this trial could be phase 1/2. I thought that phase 2 didn't begin until phase one was complete. Does this mean they will do smaller injections to test for safety followed by larger dosages in the same patients to determine efficacy? Thanks again

  4. #4
    Quote Originally Posted by JohnMarz View Post
    Hi Wise,
    Thanks for replying. I actually saw something you said on another thread about the one year wait in between trials and since you're not doing anything here until 2012 it sparked my interest in this trial again. What do you mean when you refer to therapeutic window? Also would you mind explaining how this trial could be phase 1/2. I thought that phase 2 didn't begin until phase one was complete. Does this mean they will do smaller injections to test for safety followed by larger dosages in the same patients to determine efficacy? Thanks again
    John,

    In general, phase I trials are intended to show safety and feasibility. Phase II trials are intended to optimize the treatment dose and route, inclusion and exclusion criteria, outcome measures, and other therapy parameters. One should do everything that one can during phase II trials to gain knowledge that would improve the success execution of a phase III trial that is often called a "pivotal" efficacy trial. The US FDA requires two phase III trials showing significant efficacy based upon pre-agreed criteria before they will approve the therapies. Phase IV trials are long-term safety and efficacy trials that are carried out after approval.

    Since all trials show safety and feasibility, one can often combine phase I and phase II trials. Such trials often achieve multiple goals at one time. By the way, safety evaluation continues through phase III and IV trials. Phase 1 trials are primarily oriented towards establishment of safety and feasibility. They are usually not randomized and involve small numbers of subjects (20 or less). The major outcomes of phase I trials are significant adverse events (SAE) and other complications. A significant adverse event is defined as something occurring to a patient during the trial that requires therapeutic intervention, including additional therapy (surgery or pharmaceutical) or unplanned hospitalization.

    There are no hard and fast rules for separating or combining phase I and II trials. The FDA judges the trials by their design. Some of the best designed trials are combination phase I/II trials. It might even be possible although very rare to have a phase I/II/III combination. Our trial of umbilical cord blood and lithium is a phase I/II trial: "The purpose of this study is to investigate the feasibility, safety, efficacy and optimal dose of umbilical cord blood mononuclear cell transplant in the treatment of chronic spinal cord injuries." The trial phase designation indicates both phase I and phase II. http://clinicaltrials.gov/ct2/show/N...1354483&rank=1

    To my knowledge, the Stem Cell Inc trial will be using the same dose in all the patients but first four patients will be ASIA A, the second three are ASIA B, the third set of two patients will be ASIA C. It is a very unusual and, in my opinion, innovative clinical trial design that is designed to show that the treatment can be safely given to people with incomplete spinal cord injury after having been first tried on patients with complete spinal cord injury. Because it provides information about feasibility, safety, as well as patient inclusion/exclusion criteria, it is a phase I/II trial. It is not necessarily powered to show significance in terms of efficacy. But, if it included sufficient patients, randomization, and a control group, it could even be a phase III trial.

    Wise.

  5. #5
    Wise,
    Thanks for explaining the phase I/II. I just have a few more questions. If I did enroll in this phase I/II trial and started to see results would I be able to continue my treatment in phase III or would I have to wait for the product to be approved? Is that based on the specific trial or is there a general guideline for this? Also, if I enrolled in this trial and did NOT see any results how long would I have to wait until I enrolled in another trial, your's in NJ for example. I know you said one year, would that be from the day that I started the trial or the day it ended? Thanks

  6. #6
    @Wise - therapeutic window: on the Balgrist website, the following is stated in a press release:

    The approval of Swiss Medic includes the stem cell therapy, first for three patients with complete and later in the trial for incomplete chronic (3 - 12 months after injury) sci patients.


    http://balgrist.ch/en/desktopdefault...9/9_read-1014/

    Die Zulassung von Swissmedic umfasst die Stammzellen-Therapie an zunächst drei Patienten mit kompletter und im Verlauf auch inkompletter chronischer (3 – 12 Monate nach Unfall) Paraplegie.

  7. #7
    I applied but unfortunately, I was too close to my 12 month mark. So I didnt get a chance. They did review all my medical info from my doctors. Still hoping and never giving up. Good luck to all that apply!

  8. #8
    Quote Originally Posted by Wise Young View Post
    To my knowledge, the Stem Cell Inc trial will be using the same dose in all the patients but first four patients will be ASIA A, the second three are ASIA B, the third set of two patients will be ASIA C. It is a very unusual and, in my opinion, innovative clinical trial design that is designed to show that the treatment can be safely given to people with incomplete spinal cord injury after having been first tried on patients with complete spinal cord injury. Because it provides information about feasibility, safety, as well as patient inclusion/exclusion criteria, it is a phase I/II trial. It is not necessarily powered to show significance in terms of efficacy. But, if it included sufficient patients, randomization, and a control group, it could even be a phase III trial.

    Wise.
    Dea Dr. Young,
    The cells they are using are not HLA matched, but the give imn.supression for just few months, I think 9 months.
    my quesion is,What will happen after stopping the imn.supression? is there no risk of rejection ?
    thank you.

  9. #9
    Quote Originally Posted by beuty View Post
    Dea Dr. Young,
    The cells they are using are not HLA matched, but the give imn.supression for just few months, I think 9 months.
    my quesion is,What will happen after stopping the imn.supression? is there no risk of rejection ?
    thank you.
    Yes, the StemCells transplants are fetal neural stem cells obtained from aborted fetuses. They are not HLA-matched and therefore should be immunogenic. The groups that are doing these trials believe that the cells may survive.
    • Embryonic and fetal cells may express anti-immune factors that stop immune rejection. Even if this were so, there is no guarantee that the progeny of embyronic stem cells will be anti-immune.
    • The central nervous system (CNS) is believe to be an "immunologically privileged site". While it takes longer for immune rejection to occur in the CNS, many animal studies have shown that CNS will reject allogeneic cells. For example, olfactory ensheathing glial cells and neural stem cells injected from the same strain of rats will be rejected from the brain and spinal cord within 4 weeks.
    • Immune tolerance may occur during a prolonged period of immune suppression. They hope the immune system will no recognize the cells after a period of immune suppression.
    • Some cells are non-immunogenic. For example, neurons are believed to be non-immunogenic. HUman studies indicate that dopaminergic cells from non-matched fetal sources will survive transplantation in patients with Parkinson's disease.

    In my opinion, none of these hypotheses have been satisfactorily tested in animals or humans.

    Wise.
    Last edited by Wise Young; 05-26-2011 at 02:41 PM.

  10. #10
    Dear Wise,
    Many thanks for the explanations.. I have another question regarding inclusions criterias. It is my understanding that clinical trials are generally involving patient from T2 to T11.
    Do you thing someone who's T12 - L1 with the evidence of preserved conus function could be involved ?..
    Thanks again
    George

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