Thread: ChinaSCINet Update

  1. #2651
    4 years for me and the only "positives" I see are, er, er I'm still here after 4 years,on most days I don't see that as a positive . It seems to be all we hear is the good news from researchers looking for more funding so they have a job or quack clinics promoting their 1 person success stories. In the time it takes to get a trial going there are new "cures" which make the "old" waiting for trial to start almost obsolete, a never ending circle of research, promises research. Maybe a harsh assessment of the state of play but I now understand the "5 years to a cure" cynics

  2. #2652
    If you would have read further back in this thread you would have seen that Wise's paper was published based on the 2 clinical trials in Hong Kong and China. The participants had chronic, complete injuries. They received escalating dose injections of umbilical cord mononuclear cells into their spinal cords, above and below the injury. In Hong Kong, 8 patients were injected, and the participated in regular physical therapy. Some recovered 1-2 sensory levels of feeling. At a year, some showed growth across their injury site. No other recovery occurred.

    At the Kunming Army Hospital, 20 patients received the escalating dose injections and all participated in the intense walking program for 3-6 months. 75% of these patients recovered assisted walking. (Some with rolling/upper body supporting walker, others with 4 point walkers). MRI's of the spinal cord were taken at different time points. At one year, some patients showed growth across the injury site. Also at a year, 60% began to regain bowel and bladder function.

    Here's the paper- http://www.ingentaconnect.com/search...ize=10&index=7

    Based on these results, this trial is being repeated this year in India, Taiwan, and the US.
    Last edited by Jim; 05-01-2017 at 04:32 PM.

  3. #2653
    Jim, do you have any info on when the Taiwan and India trials will start and how many people will be participating in each?

  4. #2654
    Another few questions: If the US,Taiwan,India Trials show similar results what are the next steps and what would have to happen so these treatments are available to thousands of people? What would a phase 3 trial consist of? Just more people or other factors? Is there phase 4 or is that looking too far ahead? what does each phase mean exactly?
    Thanks Jim.

  5. #2655
    Quote Originally Posted by greenseed View Post
    Jim, do you have any info on when the Taiwan and India trials will start and how many people will be participating in each?
    India & Taiwan Phase IIb trial- 18 subjects each, 2 groups- Group 1: cord blood injections + intensive walking, Group 2: cord blood + lithium + walking. They will to start this year, Taiwan prob first.

    Quote Originally Posted by greenseed View Post
    Another few questions: If the US,Taiwan,India Trials show similar results what are the next steps and what would have to happen so these treatments are available to thousands of people? What would a phase 3 trial consist of? Just more people or other factors? Is there phase 4 or is that looking too far ahead? what does each phase mean exactly?
    Thanks Jim.
    In the US IIb Trial there will be 27 patients, 3 groups (FDA required a walking group only.) As soon as subjects are chosen, anyone can apply online for Expanded Compassionate Use (also in India.) If granted, person can have the procedure at cost (Estimate $150K- 50 for operation and 3 days of hospitalization, 50 for 6 weeks of outpatient physical rehab, 50 for 3-6 months of intensive walking at a rehab center.)

    The IIb trials will tell us whether the treatment is effective, as in the ChinaSCINet the Phase II. It will also tell us if lithium is effective. If it is not, lithium will be dropped from the Phase III Trial. Phase III will consist of 240 patients around the world. If proven to be effective, it will be approved for treatment.

  6. #2656
    Thanks for that info Jim.

    Im a bit confused with the Expanded Compassionate Use part though.
    As soon as subjects are chosen for the India and US trials ANYONE can have the procedure done in those countries as long as they can pay & find someone & somewhere to do the procedure? If that is correct i imagine there would be only specific places this could be done. If so where would those places be? Would it be difficult to acquire the right cells at this time?

  7. #2657
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    Also, can the intensive training be done outside the program (aka, with PTs nearer to home).
    T3-T7 complete since Sept 2015

  8. #2658
    When you say anyone can apply for the expanded compassionate use, does that include C's and D's who don't fit the trial criteria?

    150K won't allow me to try regardless though.

    Thanks for the updates Jim.

  9. #2659
    Quote Originally Posted by greenseed View Post
    Thanks for that info Jim.

    Im a bit confused with the Expanded Compassionate Use part though.
    As soon as subjects are chosen for the India and US trials ANYONE can have the procedure done in those countries as long as they can pay & find someone & somewhere to do the procedure? If that is correct i imagine there would be only specific places this could be done. If so where would those places be? Would it be difficult to acquire the right cells at this time?
    Yes, must find a qualified neurosurgeon. The best choice would be one who performed the procedure in our trial. The cells will be provided by StemCyte at cost, shouldn't be a problem finding a matching unit.

    Quote Originally Posted by Mize View Post
    Also, can the intensive training be done outside the program (aka, with PTs nearer to home).
    Yes

    Quote Originally Posted by nphuskers View Post
    When you say anyone can apply for the expanded compassionate use, does that include C's and D's who don't fit the trial criteria?

    I'm not sure if we need to do a trial of incompletes before the FDA will allow Compassionate Use for Incompletes.


    150K won't allow me to try regardless though.
    Fees with Dr's, hospitals, and rehab centers are negotiable. You can also try to get insurance to pitch in. In all 6 ChinaSCINet trials, not one Dr. was paid.

    Thanks for the updates Jim.

  10. #2660
    Thanks for the info Jim. Forgive me if this is to forward of a question but are you going to apply for Compassionate Use and get this treatment done if it goes through?

    I wonder how worth it it would be to get the cell treatment but do no PT and walking training. As in would bladder bowel function improve without those aspects? I would imagine they might but who knows. Im going to look at the HK results again to see if theres anything in there that speaks to that.

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