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Thread: Spinal Cord Injury Network USA (SCINetUSA)

  1. #451
    Quote Originally Posted by Jim View Post
    The estimate for compassionate use is 50k for the surgery/3 days inpatient hospital stay, 50k for 6 weeks of intensive PT, 50k for 3-6 months of walking program. If you don't have a qualified surgeon near you, housing would be another expense. If chosen for the clinical trial, the only cost would be housing, clinical trials are free.
    Jim, could you please clarify for me "If you don't have a qualified surgeon near you". Does that mean that surgeons from various locations around the country will be trained in the surgical procedure for this therapy and will be available for compassionate use at the same time as the surgeons at the centers you mentioned? Also, if that's the case, what about the therapists? Will they be trained and available for compassionate use outside the listed centers as well? Or, is a trip to the east coast a necessity to participate in the therapy under the compassionate use clause?
    Thank you.


  2. #452
    tumbleweeds, I would assume the Expanded Compassionate Use (ECU) legislation includes rules that must be followed. For example, one requirement would be for ECU to follow the same protocol as the clinical trial. Training will be necessary for surgeons and physical rehab professionals. Maybe interested parties will come and observe the surgery/walking. Maybe Wise has this planned out, I don't know.

  3. #453
    Thanks Jim, please give an update when you get more info.


  4. #454
    Senior Member
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    Quote Originally Posted by Jim View Post
    MomNoah, Wise met with the FDA for the pre-IND and they requested a safety study. This has been completed and the results were as expected, no safety issues with the cells. The IND paperwork (thousands of pages) is being finalized and will soon be submitted.

    There is no safety issue with this therapy. Twenty-eight subjects received the umbilical cord blood injections and none lost function. The majority regained the ability to walk with assistance, and many regained the ability to pee and poop. These were all complete patients.
    Are we talking human trial results? That would be amazing!!!!!

  5. #455
    The mom, here are the results of the trial. We will be repeating this trial in the US, Taiwan, and India. Any questions, shoot.

    http://www.ingentaconnect.com/search...ize=10&index=7

  6. #456
    Senior Member
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    Quote Originally Posted by Jim View Post
    The mom, here are the results of the trial. We will be repeating this trial in the US, Taiwan, and India. Any questions, shoot.

    http://www.ingentaconnect.com/search...ize=10&index=7
    Thank you for responding quickly, Jim!

    I see that one individual from KM was unable to proceed as an HLA match wasn?t found. Additionally, it seems the greater the HLA match the better the outcome? My daughter is having a baby ? should we make arrangements to save the cord blood for my son who has a C6-7 injury?

    According to Dr. Young?s article published in 2014, the method for umbilical cord blood processing makes a difference. We are in Texas. Where do we go for a PD processing?

    Independent for bowl and bladder ? what does this mean - proceed as an able bodied individual or quads do not need assistance as they may dig stem?

    Are folks in this research projects actually walking or is their upper body throwing their legs forward? Thank you!

  7. #457
    Quote Originally Posted by The mom View Post
    Thank you for responding quickly, Jim!

    I see that one individual from KM was unable to proceed as an HLA match wasn?t found. Additionally, it seems the greater the HLA match the better the outcome? My daughter is having a baby ? should we make arrangements to save the cord blood for my son who has a C6-7 injury?

    According to Dr. Young?s article published in 2014, the method for umbilical cord blood processing makes a difference. We are in Texas. Where do we go for a PD processing?

    Independent for bowl and bladder ? what does this mean - proceed as an able bodied individual or quads do not need assistance as they may dig stem?

    Are folks in this research projects actually walking or is their upper body throwing their legs forward? Thank you!
    Hi The Mom,

    The odds are, the cord blood will not match your son, but StemCyte has a great deal. If you donate it to their public bank, they will give you a matching unit for free. Contact them- https://stemcyte.com/

    Independent means they are able to do their bowel/bladder care themselves. On top of that, some no longer have to cath, or use suppositories to evacuate.

    75% are able to step using the upper body supporting rolling walker. Videos show stepping, not swinging. Some progressed to a four point walker and stopped using wheelchair at home. I don't think any stopped using wheelchair out in public, It's just too hard.

  8. #458
    Quote Originally Posted by Jim View Post
    Videos show stepping, not swinging.
    Are the videos available online for us to see? I know they haven't been in the past, just wondering if that's changed.


  9. #459
    Quote Originally Posted by Jim View Post
    The IND paperwork (thousands of pages) is being finalized and will soon be submitted..
    Jim, that was from 9/23. How's the paper coming along? Sorry, just getting antsy.


  10. #460
    I can't post the videos.

    Last I heard, the CRO has the paper, will soon be submitted.

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