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Why not trials for lower injuries?

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  • Why not trials for lower injuries?

    As some trials have started and some will be soon but there is no space for lower spinal injuries in any of trials. Is it not fair? Why lower injuries are not included in any trials?


  • #2
    Don't ask what clinical trials can do for you, ask what you can do for clinical trials.

    Fenexy: Proyecto Volver a Caminar (soon in english too)


    • #3
      The main reason is because there is currently no immune-compatible source of neural stem cells for transplantation, unless people want to consider removing neural stem cells from the brain and transplanting them into the spinal cord. There have been many claims of converting bone marrow or umbilical cord blood cells into neurons but these have been done in the dish.

      At least one group (Mari Dezawa, et al.) have been able to consistently reprogram bone marrow cells to produce neurons and formed a company (Sanbio) to raise funds for and to develop the technology to take it to clinical trials. Because genetic manipulations are involved, approval by the FDA will take longer and require additional hurdles to show safety.

      There is a lot of talk right now of using neural stem cells from embryonic stem cells, which are believe to be immune privileged. As you know, it took Geron four years to get the FDA to approve of oligodendroglial precursor cells derived from embyronic stem cells. The Geron Phase 1 trial is just starting.

      A company named Stem Cell Inc. and Neural Stem Inc. have started clinical trials transplanting fetal stem cells into spinal cords of people with spinal cord injury and amyotrophic lateral sclerosis. If these trials show that the treatment is safe, I suspect that they will start targetting lumbosacral spinal cord injuries.

      There is also a lot of excitement about using induced pluripotent stem cells or induced neurons by genetically programming the cells. It may take a while for these cells to reach clinical trials because they involve not only genetic programming of the cells but also the problem of tumor formation and pluripotency.

      I am very optimistic by the work of Mari Dezawa who recently reported that she was able to isolate a type of cells that she called MUSE cells from bone marrow and other sources of adult stem cells. She showed that these cells can be readily isolated, expanded, and transformed into neural stem cells without having to use genetic reprogramming.

      I am very worried about this work being interrupted by Mari Dezawa works at Tohoku University in Sendai, Japan. The earthquake there devastated the city and also the university. It may be some time before they can restart their experiments. I have offered to help them in any way possible. It has been very difficult in northern Honshu for the past three weeks.



      • #4
        Thank u for detailed reply and some good information.

        Wise do you think i can recover bladder bowel and sexual function with neural stem cells once proven safe or combination therapy will be needed for my full recovery? If combination therapy then what it would be?

        Hope ur trials show some good results and then may be in lumbosacral injuries too.


        • #5
          Dr. Young, what do you think about this article about IPS cells being rife with mutations. Would it be a big roadblock in using them for clinical trials/therapy? Can this problem (mutations) be easily overcome? Thanks.