Thread: ChinaSCINet Update

  1. #2401
    It is getting to beyond the two-year mark for some parents in the original Kunming study. We are currently trying to find a time and situation to bring the patients back. It is a lot of trouble and costly for patients to travel back to the center. So, we need to raise the funds for that as well. Several have come back on their own to visit because they live nearby. At the present, Kunming is doing another trial... assessing the effects of surgery and walking training alone, without cell transplants.

    Regarding participation in an upcoming trial in China, several changes this year may postpone the trial. Last April, the China Food and Drug Administration announced new regulations that seemed to require a two-stage approval for clinical trials, one at the provincial level and a final approval in Beijing. However, they apparently did not have the infrastructure to implement this two-stage approval. In August, we heard that they were going to change the system to just provincial approval of selected hospitals as "stem cell centers" and allow trials as such centers. Three of our centers have applied for stem cell center status. So, we are waiting for these applications to clear before going forward.

    The path for getting national approval of a cellular therapy is still unclear. I assume that the original proposal for initial provincial approval followed by Beijing approval still stands. No non-Chinese company is allowed to do stem cell therapies. So, whatever company wants to do a trial in China must find a Chinese company to partner with. Until the recent stock market crash, some Chinese investment groups were actually looking around for American stem cell companies to acquire. Right now, things are a bit mixed up in terms of clinical trials in China. I hope that it will clear up soon. As soon as we know that a trial has been approved, it will be announced here on CareCure and also on www.clinicaltrials.gov.

    We are applying for the trials in the U.S. and India. Those applications are still in progress. As soon as something solid is know, we will likewise announce these trials here and on www.clinicaltrials.gov. None of the trials are recruiting and so there is no point in applying or trying to get on various lists.

  2. #2402
    Thank you for the update and for your continued pursuit.

    Best,

    Justin

  3. #2403
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    Thank you Dr. Young! It's always great to hear from you!

  4. #2404
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  5. #2405

    publication

    Quote Originally Posted by taymas View Post
    This.

    If I remember correctly, they returned it because it was too "specialised." But really, FOUR rejections?
    I am not sure what the current status is on publication. But (as someone with a lot of refereed publications in a totally different field) I am familiar with the process.... and I would guess that Wise would feel it would not be appropriate to comment in detail. What would be galling would be the length of time taken to "return without review". That's an editorial decision that should take a days not months. It may be a reflection of the competitive, high stakes nature of publishing in sci cures. Maybe Wise should have been more aggressive with the telephone (to get a faster decision). Who knows. In any case there are a good number of relevant journals and this appears to be quality applied research, so I have no doubt there will be a positive result.

  6. #2406
    Wise will soon post an update.

  7. #2407
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    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

  8. #2408
    Yes, we weren't sure when it would be available online.

  9. #2409
    Congratulations on getting it published, this seems like great news and gives us all some hope that something can be done.

    Couple of questions if I may, it says that some were able to empty their bladder without a catheter. I take it that means they could activate the muscles to empty the bladder?

    The question really is did they know when their bladder was full?
    Using an intermittent catheter isn't the end of the world, the problem is knowing when to do it.

    I suppose the same question regarding the bowels, do they know when they need to go to the toilet?
    The document says that accidents were reduced/eliminated - so that sort of suggests that they knew when they needed to empty. Is that correct?

  10. #2410
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    Great news! Congratulations!

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