Page 1 of 4 1234 LastLast
Results 1 to 10 of 37

Thread: Announcement: Clinical Trial Meeting in Hong Kong for CN102B

  1. #1

    Announcement: Clinical Trial Meeting in Hong Kong for CN102B

    We will hold the first subject recruitment meeting for CN102B "Safety and Feasibility of Umbilical Cord Blood Cell Transplant into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Trial". on January 16, 2010 at 1 pm in the Lecture Room on the 7th floor of the MacLehose Medical Rehabilitation Centre, Sha Wan Drive, Pokfulam, Hong Kong. We hope to start the trial early March 2010. At the meeting, Drs. Waisan Poon, Gilbert Leung, Yatwa Wong, and I will talk about the clinical trial and answer questions.

    The trial has been posted on http://clinicaltrials.gov/ct2/show/NCT01046786. Briefly, the trial will recruit 20 subjects with chronic traumatic spinal cord injury (>1 year after injury and stable neurological function) at C5 and T10 levels inclusive, who are classified on the ASIA Impairment Scale as A (“complete” spinal cord injury), who do not have significant contraindications to the surgery, methylprednisolone, or lithium, and for whom we can find an umbilical cord blood unit that matches at least 4:6 human leukocyte antigens (HLA) -A, -B, and -DR. The institutional review boards (IRB) of HKU and CUHK, and Hong Kong Department of Health have approved the trial.

    The subjects will be randomized to five treatment groups of four subjects. The first three groups will receive increasing volumes (4, 8, and 16 µliters) of 100,000 HLA-matched mononuclear cells/µliter, injected four times 3-mm deep into dorsal root entry zones of spinal cord above and below the injury site. The fourth group will receive the highest safe transplant volume plus an intravenous bolus of 30 mg/kg methylprednisolone to improve survival of transplanted cells. The fifth group will receive the transplant, methylprednisolone, and a 6-week course of oral lithium carbonate titrated to serum levels of 0.6 to 1.0 mM. Lithium stimulates the cells to grow and produce growth factors that may stimulate regeneration.

    The U.S. company StemCyte will donate the HLA-matched human umbilical cord blood cells. . The units have been tested extensively to rule out disease. A highly-certified U.S. laboratory (Vista Biologicals) will thaw, isolate, and purify mononuclear cells from the units. These cells include CD34+ and CD133+ stem cells in umbilical cord blood. The cells will shipped from the United States to Hong Kong without culturing or growing of the cells. Stemcyte units are certified by National Marrow Donor Program criteria for safety of transplantation to treat other conditions.

    The surgery will be done at Prince-of-Wales Hospital (Dr. Waisan Poon of the Chinese University of Hong Kong) and Queen Mary Hospital (Dr. Gilbert Leung, Hong Kong University). The hospitalization period will be at the discretion of the principal investigators and will probably be one week. Rehabilitation will be voluntary after the transplants. Subjects will be followed up at 6 weeks, 6 months, and 12 months after the transplants. The subjects will return to the MacLehose Rehabilitation Center to be examined at these times. At 12 months, the subjects will get an MRI and blood tests.

    While the goal of the trial is to assess feasibility and safety of transplanting umbilical cord blood cells into the spinal cord, the cells may improve neurological function and we therefore will be examining subjects for neurological changes at 6 weeks, 6 months, and a year after transplantation. The injection may cause local damage to the spinal cord and we will be assessing for neurological changes during the first week after surgery to assess adverse effects of the transplants. Such damage is unlikely at the small volumes (4-16 µliters) that will be injected. In China, patients routinely get >35 µliter cell injections into spinal cord without neurological loss. Cell transplants may cause inflammation or meningitis but this is unlikely because the cells are extensively tested to rule out infectious disease and are HLA-matched to reduce likelihood of immune rejection.

    The treatment is based on data from multiple animal studies indicating that umbilical cord blood mononuclear cells (UCBMC) are well-tolerated when transplanted into the spinal cord and improve function in animals after spinal cord injury. Methylprednisolone may increase survival of transplanted cells. Lithium stimulate umbilical cord blood mononuclear cells to produce growth factors (neurotrophins) that stimulate regeneration in the spinal cord. Based on the results of this phase II trial, we will decide whether and what type of phase III trial we will do to evaluate the efficacy of umbilical cord blood mononuclear cells with and without lithium.

    Wise Young, Ph.D., M.D.
    Richard H. Shindell Chair in Neuroscience & Director
    W. M. Keck Center for Collaborative Neuroscience, Rutgers University
    604 Allison Road, Piscataway, New Jersey 08854-8082

    15 January 2010

  2. #2
    Senior Member
    Join Date
    Jun 2005
    Location
    Norway
    Posts
    17,427
    Good luck.

  3. #3
    Senior Member 0xSquidy's Avatar
    Join Date
    Dec 2009
    Location
    Barcelona (Spain)
    Posts
    1,072
    Hope this is the beginning of the end

  4. #4
    Godspeed.
    Donnie: Dr. Xiao, What are your thoughts on a cure/combination therapy for SCI's??
    CG Xiao: Donnie, I don't want to disappoint you, but I think it is impossible to restore the continuity of the cord or "bridge the gap" in the near future, let's say: 50 years. Dr Wise Young has been my most respected scientist in SCI. He has dedicated and contributed to SCI no other can match.

  5. #5
    Here's hoping this will be the start of something for all who dream of the impossible. May we someday walk together on the path near my home and discuss the success of the therapy you are about to start.

    T.J.

  6. #6
    yes about time its moving forward

  7. #7
    Waited along time to read that , others even longer. I hope this gets some recovery going.
    oh well

  8. #8
    Senior Member
    Join Date
    Sep 2005
    Location
    In your nightmares
    Posts
    1,740
    Lovely. Maybe I should donate more to get good news...

  9. #9
    Go get'em, Wise.

  10. #10
    This is good. Thank you. Mary

Similar Threads

  1. Hello from Hong Kong
    By Jim in forum Cure
    Replies: 46
    Last Post: 05-13-2009, 12:29 AM
  2. New SCI from Hong Kong
    By Cancankwok in forum New SCI
    Replies: 20
    Last Post: 04-21-2008, 10:43 AM
  3. Replies: 16
    Last Post: 03-19-2007, 09:33 AM
  4. Replies: 53
    Last Post: 12-24-2005, 04:21 PM
  5. HONG KONG
    By bibby in forum Recreation, Sports, Travel, & Hobbies
    Replies: 11
    Last Post: 01-22-2005, 10:12 AM

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •