Thread: ChinaSCINet Update

  1. #2421
    taymas,

    Those with syringomyelia/cysts are not excluded from the IIb trial.

  2. #2422
    Quote Originally Posted by Jim View Post
    taymas,

    Those with syringomyelia/cysts are not excluded from the IIb trial.
    AAAAAAAAAAAAAARRRRGHHHHHHHHHHHHHH JIM YOURE FULL OF GOOD SURPRISEA WOOHOOO!!!!

    ...It's a shame I'm in the UK... one day though...

  3. #2423
    If you want to receive info about how to apply to be in the trial, email me and I will add you to our list- jimbenn@rutgers.edu.

  4. #2424
    Congrats to all involved in this trial. Looks like MP and Lithium is the key as the scores did improve when using those. Keep up the good work to all those involved, good job. The publishing of this gives people hope. I know it has been a long road.
    "Life is about how you
    respond to not only the
    challenges you're dealt but
    the challenges you seek...If
    you have no goals, no
    mountains to climb, your
    soul dies".~Liz Fordred

  5. #2425
    Quote Originally Posted by Jyi View Post
    Is this the publication? few days ago.


    Phase I-II Clinical Trial Assessing Safety and Efficacy of Umbilical Cord Blood Mononuclear Cell Transplant Therapy of Chronic Complete Spinal Cord Injury
    Authors: Hui Zhu1, 2; Waisang Poon3; Yansheng Liu1, 2; Gilberto Ka-Kit Leung4; Yatwa Wong4; Yaping Feng2; Stephanie C. P. Ng3; Kam Sze Tsang3; David T. F. Sun3; David K. Yeung3; Caihong Shen1, 2; Fang Niu1, 2; Zhexi Xu1, 2; Pengju Tan1, 2; Shaofeng Tang2; Hongkun Gao1, 2; Yun Cha2; Kwok-Fai So5, 6, 7; Robert Fleischaker8; Dongming Sun9; John Chen5; Jan Lai5; Wendy Cheng5; Wise Young9, 5

    Abstract:
    Umbilical cord blood (UCB) mononuclear cells (UCBMNC) transplants improve recovery in animal spinal cord injury (SCI) models. We transplanted UCBMNC into 28 people with chronic complete SCI in Hong Kong (HK) and Kunming (KM). Stemcyte Inc. donated UCBMNC isolated from human leukocyte antigen (HLA=4:6) matched UCB units. In HK, four participants received four 4-?L (1.6 million cells) injections into dorsal entry zones above and below the injury site and another four received 8-?L (3.2 million cells) injections. The 8 participants averaged 13 years after C5-T10 SCI. Magnetic resonance diffusion tensor imaging of 5 participants showed white matter gaps at the injury site before treatment. Two participants had fiber bundles growing across the injury site by 12 months and the rest had narrower white matter gaps. Motor, walking index of SCI (WISCI) and spinal cord independence measure (SCIM) scores did not change. In KM, five groups of four participants received four 4-?L (1.6 million cells), 8-?L (3.2 million cells), 16-?L (6.4 million cells), 6.4 million cells plus 30mg/kg methylprednisolone (MP), or 6.4 million cells plus MP and a 6-week course of oral lithium carbonate (750 mg/day). KM participants averaged 7 years after C3-T11 SCI and received 3-6 months of intensive locomotor training. Before surgery, only 2 participants walked 10 meters with assistance and did not need assistance for bladder or bowel care before surgery. The rest could not walk or do their bladder and bowel care without assistance. At a year (41-87 weeks), WISCI and SCIM scores improved, i.e. 15/20 participants walked 10 meters (p=0.001); 12/20 did not need assistance for bladder care (p=0.001) or bowel care (p=0.002). Five participants converted from complete to incomplete (2 sensory, 3 motor; p=0.038) SCI. We conclude that UCBMNC transplants and locomotor training improved WISCI and SCIM. Additional clinical trials are proposed.

    http://www.ingentaconnect.com/conten...1483_Zhu_et_al
    No mention of sexual function improvement, even if there was it is such a taboo most studies don't even address it! yet evidently majority of injuries see sexual function as their greatest loss and most desired return ( other then hand function for cervical injuries ) it has a dramatic impact on quality-of-life, ANY improvements would obviously have a dramatic improvement on quality-of-life... But like every spinal cord injury trial nothing was mentioned on the subject

  6. #2426
    Amazing ����. So it's finally officially published Right?
    Great step moving forward .
    When are the Second round of phase 2 in India and the states going to start?

  7. #2427
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    Quote Originally Posted by JamesMcM View Post
    No mention of sexual function improvement, even if there was it is such a taboo most studies don't even address it! yet evidently majority of injuries see sexual function as their greatest loss and most desired return ( other then hand function for cervical injuries ) it has a dramatic impact on quality-of-life, ANY improvements would obviously have a dramatic improvement on quality-of-life... But like every spinal cord injury trial nothing was mentioned on the subject
    I have to wonder if this is just a result of the taboo of discussing sexual issues? I know my doctors and therapists avoided any talk along these lines even when it was listed as something they were to address in my care plan.

  8. #2428
    Quote Originally Posted by Jim View Post
    The Phase IIb may start by the end of the year in the US. My understanding is once all 27 patients are enrolled, the treatment will be eligible for expanded compassionate use to anyone.
    Just to clarify, are you saying the treatment will be eligible after enrollment or do you mean after enrollment, execution and data analysis? Two very different timescales for those that are clearly holding out hope for this treatment in the US.

  9. #2429
    Quote Originally Posted by JamesMcM View Post
    No mention of sexual function improvement, even if there was it is such a taboo most studies don't even address it! yet evidently majority of injuries see sexual function as their greatest loss and most desired return ( other then hand function for cervical injuries ) it has a dramatic impact on quality-of-life, ANY improvements would obviously have a dramatic improvement on quality-of-life... But like every spinal cord injury trial nothing was mentioned on the subject
    Actually, they didn't think to include sexual function as an outcome measure. When the subjects are examined for the 3 year follow-up they will ask.
    BTW, sexual function is also controlled by a central pattern generator, so the chances of return are good.

    While an inpatient at the Shepherd Center we were required to take classes that covered SCI sexuality. I would guess that most of the SCI speciality hospitals have the same.

    Quote Originally Posted by mrTerell View Post
    Amazing. So it's finally officially published Right?
    Great step moving forward .
    When are the Second round of phase 2 in India and the states going to start?
    I believe the publication date is sometime in May.

    Phase IIb might begin in India and the US this year. It's looking like India will start before us.

  10. #2430
    Quote Originally Posted by Fly_Pelican_Fly View Post
    Just to clarify, are you saying the treatment will be eligible after enrollment or do you mean after enrollment, execution and data analysis? Two very different timescales for those that are clearly holding out hope for this treatment in the US.
    Yes, a major difference in time!

    When the 27 patients are randomized to the 3 groups (cell transplantation + walking/rehab, cell transplantation + lithium + walking/rehab, walking/rehab only), the therapy will then be available.

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