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Thread: Spinal Cord Injury Network USA (SCINetUSA)

  1. #331
    Senior Member Tufelhunden's Avatar
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    Quote Originally Posted by Wise Young View Post

    In 2010, we proposed to do the following trials in the U.S.
    US102. Phase II trial of UCBMC+Lithium±Rehab in 20 subjects.
    US103. Phase III trial: Rehab, Rehab+Ltihium, Rehab+UCBMC, Rehab+UCBMC+lithium, 120 subjects.
    US104A. Phase II trial of UCMBC+lithium±rehab in 20 young subjects (8-17 years old).
    US104B. Phase II trial of UCBMC+ltihium±rehab in 20 older subjects (65-80 years old).
    US104C. Phase II trial of UCBMC+lithium±rehab in 20 subjects with high cervical injuries (C1-C4).
    I take it that 104A and 104B will be concurrent?
    No one ever became unsuccessful by helping others out

  2. #332
    Quote Originally Posted by Wise Young View Post
    In 2010, we proposed to do the following trials in the U.S.
    US102. Phase II trial of UCBMC+Lithium±Rehab in 20 subjects.
    US103. Phase III trial: Rehab, Rehab+Ltihium, Rehab+UCBMC, Rehab+UCBMC+lithium, 120 subjects.

    Wise.
    in US 102, will those 20 subjects be broken up into groups with lower dosage of cells or lithium?

    and in US103, basically the same question. im assuming 30 subjects in each group. but then is there a subgroup of different dosages?

    hope that made sense.

  3. #333
    Quote Originally Posted by Wise Young View Post
    Unfortunately, Dr. Charlotte Smith who was our investigator at Brackenridge has left that hospital. So, we are currently considering several options, including not doing US102 or doing US102 in New Jersey instead. We, however, are continuing to plan to initiate US103 in 2013.

    Wise.
    Dr Young, does this mean that Brackenridge is out?
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
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  4. #334
    Quote Originally Posted by muskie View Post
    Hi Dr Young, if this phase II is moved to jersey where would the surgeries be performed?
    Bob Heary at UMDNJ Newark has indicated that he will do the surgery. We are still discussing. Wise.

  5. #335
    Quote Originally Posted by ineedmyelin View Post
    Dr Young, does this mean that Brackenridge is out
    No, it means what I said. I don't think that we can get the trial started in Brackenridge within 2012. Much depends on whether we can find another investigator soon and whether we raise the funds of the trials. Wise.

  6. #336
    Quote Originally Posted by Barrington314mx View Post
    in US 102, will those 20 subjects be broken up into groups with lower dosage of cells or lithium?

    and in US103, basically the same question. im assuming 30 subjects in each group. but then is there a subgroup of different dosages?

    hope that made sense.
    Barrington, the final design of the trial depends on both investigators and FDA agreeing. I am just listing what we proposed in 2010 to do. Wise.

  7. #337
    Quote Originally Posted by Tufelhunden View Post
    I take it that 104A and 104B will be concurrent?
    Hi, Tufelhunden. These are being done in different hospitals and therefore there is no linkage. Wise.

  8. #338
    We are continuing to work on seeing if we can do the planned trial at Brackenridge. In the meantime, we are working hard on getting a trial going at UMDNJ Newark, Kessler Rehabilitation Institute, and the East Orange VA Hospital. The details are still being discussed and I will post them as soon as they become solidified.

    Wise.

  9. #339
    US104A. Phase II trial of UCMBC+lithium±rehab

    When is this trial going to take place ...... my daugther is 7 at the moment but if the trial starts in 2013 she'll be 8.

    I'm going to google it right now!!

    Please let me know!

    Best regards,
    Inci
    mom of Ameli

  10. #340
    Senior Member Wills77's Avatar
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    Wise if you do start trials at kessler in 2012 will it include asia B and C or just asia A patients?

    Thanks
    c6 inc since 2-19-11
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