Page 5 of 6 FirstFirst 123456 LastLast
Results 41 to 50 of 51

Thread: ChinaSCINet and NASCINet meetings in China

  1. #41
    Quote Originally Posted by Mike Pell View Post
    Dr. Young
    Thank you for all you do. I will be donating and e-mailing friends and family a couple of the post as well as the Keck Center website, encouraging them to donate.

    I'm very interested in the locomotor training. I recently qualified because I am a C4 Asia C. I'm presently on 15 mg of baclofen orally and in the process of weaning off baclofen pump (presently 130 mcg). I go through the final screening at the end of the month and part of that is to check my tone. I'm concerned because I very much want to get into this program but worry about the tone issue. How much tone would disqualify me and why? I'll be more than willing to deal with any amount of tone to participate.

    Mike
    Mike, I am glad that you qualified forthe locomotor training. Are you taking 15 mg per day of baclofen or is this 15 mg three times a day? If you had severe enough spasticity to require a baclofen pump, my guess is that you will require some baclofen to control your tone. It is often complicated to wean off baclofen at the same time that you are starting locomotor training. The training itself should reduce spasticity.

    You would not be eligible for the nascinet clinical trial because of the C4 and ASIA C. The inclusion criteria are C5 through T10 inclusive and ASIA A. The reason for the C5-T10 is because we are injecting the cells above and below the injury site; a C4 would require injection into C3 where the breathing centers are while a T11 would require injection into the lumbar enlargement where the locomotor centers are.

    We are limiting the study to ASIA A in the United States because we would need to do about 400 subjects to get sufficient data to detect significant differences. In the chinascinet trial, we will be studying about 400 subjects.

    In the U.S., we will be studying three treatment groups with 60 subjects per treatment group: lithium only, UCBMC transplant only, and UCBMC plus lithium. The http://nascinet.org still refers to a group that is rehabilitation only. That should be changed now to lithium only.

    If the nascinet and chinascinet trials shows that the treatment is safe and improves function, that is the time that we should be doing a trial to assess its effects on incomplete injuries. Since the chinascinet trial will have incomplete (ASIA C) patients, a second phase 3 trial of incompletes will confirm and allow the FDA to approve the therapy for both completes and incompletes.

    Some people might be disappointed to be excluded from the study. Note that the UCBMC transplants may not be beneficial. In that case, we would go on to test other cells and combination therapies. If it is successful, then it would be widely available.

    Wise.

  2. #42
    I am not sure how to phrase my question. I would like to know if C4 will always be a barrier to treatment or is it just in this round of trials? Is there some point were the results will allow you to conclude that you would be willing to inject at C3? Will C3 always be considered a no go?


    Quote Originally Posted by Wise Young View Post
    The reason for the C5-T10 is because we are injecting the cells above and below the injury site; a C4 would require injection into C3 where the breathing centers are while a T11 would require injection into the lumbar enlargement where the locomotor centers are.
    ______
    Awe at my magnificent coq!

    "You may say I'm a dreamer
    but I'm not" - J. Lennon

  3. #43
    Quote Originally Posted by eks View Post
    I am not sure how to phrase my question. I would like to know if C4 will always be a barrier to treatment or is it just in this round of trials? Is there some point were the results will allow you to conclude that you would be willing to inject at C3? Will C3 always be considered a no go?
    No, we will be able to treat C3. The problem is that we need to have a consistent way of injecting the cells into the spinal cord in order to compare the results. If we do it in another way, we would have to have another clinical trial. We are thinking of a clinical trial just for high quads, in which the cells will be injected at and below the injury site rather than above and below the injury site. However, the risk entailed in such a trial could only be justified if we find some efficacy in our current clinical trial.

    The way that this would be done is to run a phase 2 trial of perhaps 20 people with C2-4 injuries, to determine feasibility and safety.

    Wise.

  4. #44
    Thank you for the response Dr. Young.
    ______
    Awe at my magnificent coq!

    "You may say I'm a dreamer
    but I'm not" - J. Lennon

  5. #45
    Quote Originally Posted by Wise Young View Post
    Mike, I am glad that you qualified forthe locomotor training. Are you taking 15 mg per day of baclofen or is this 15 mg three times a day? If you had severe enough spasticity to require a baclofen pump, my guess is that you will require some baclofen to control your tone. It is often complicated to wean off baclofen at the same time that you are starting locomotor training. The training itself should reduce spasticity.

    You would not be eligible for the nascinet clinical trial because of the C4 and ASIA C. The inclusion criteria are C5 through T10 inclusive and ASIA A. The reason for the C5-T10 is because we are injecting the cells above and below the injury site; a C4 would require injection into C3 where the breathing centers are while a T11 would require injection into the lumbar enlargement where the locomotor centers are.

    We are limiting the study to ASIA A in the United States because we would need to do about 400 subjects to get sufficient data to detect significant differences. In the chinascinet trial, we will be studying about 400 subjects.

    In the U.S., we will be studying three treatment groups with 60 subjects per treatment group: lithium only, UCBMC transplant only, and UCBMC plus lithium. The http://nascinet.org still refers to a group that is rehabilitation only. That should be changed now to lithium only.

    If the nascinet and chinascinet trials shows that the treatment is safe and improves function, that is the time that we should be doing a trial to assess its effects on incomplete injuries. Since the chinascinet trial will have incomplete (ASIA C) patients, a second phase 3 trial of incompletes will confirm and allow the FDA to approve the therapy for both completes and incompletes.

    Some people might be disappointed to be excluded from the study. Note that the UCBMC transplants may not be beneficial. In that case, we would go on to test other cells and combination therapies. If it is successful, then it would be widely available.

    Wise.

    Dr. Young, I'm on 15 mg per day. At one time I was on 140 mg , and approximately 300 mcg through the pump daily. I've been gradually reducing baclofen for approximately a year and a half. I was in the Fampridine SR study at Kessler a few years back. I now take 25 mg 4 AP, SR twice a day.


    I'm a little confused about criteria for the NRN program.Originally , I was told that, as long as I was willing, I would be able to wean off baclofen pump while in the locomotor training program. More recently I was told that I needed to have my pump deactivated before starting the program, then would be allowed to take 20 mg orally per day. Do you know if that's usually the case? It is for this reason that I accelerated decreasing my pump. My concern is that if I deactivate pump completely, I will have too much tone to be allowed in . It makes sense when you say, the program will help reduce my spasticity. I've also been riding FES bike three to four times per week as well as being in standing wheelchair for the past two years, which has helped with spasticity.


    I understand I don't meet the criteria for the clinical trial. Reading about the locomotor training and walking therapy in China brought about my questions concerning NRN locomotor training program here Thanks again, you inspire us to keep fighting!

    Mike
    Last edited by Mike Pell; 05-10-2009 at 09:42 PM. Reason: Clarity
    Mike P.

  6. #46
    Quote Originally Posted by Mike Pell View Post

    I understand I don't meet the criteria for the clinical trial. Reading about the locomotor training and walking therapy in China brought about my questions. Thanks again, you inspire us to keep fighting!

    Mike
    Hi Mike- You're ineligible for the trial because of the level of your injury C4. Same goes for me. Success breeds success, so Keep on keeping on.

  7. #47
    Quote Originally Posted by Mike Pell View Post
    Dr. Young, I'm on 15 mg per day. At one time I was on 140 mg , and approximately 300 mcg through the pump daily. I've been gradually reducing baclofen for approximately a year and a half. I was in the Fampridine SR study at Kessler a few years back. I now take 25 mg 4 AP, SR twice a day.


    I'm a little confused about criteria for the NRN program.Originally , I was told that, as long as I was willing, I would be able to wean off baclofen pump while in the locomotor training program. More recently I was told that I needed to have my pump deactivated before starting the program, then would be allowed to take 20 mg orally per day. Do you know if that's usually the case? It is for this reason that I accelerated decreasing my pump. My concern is that if I deactivate pump completely, I will have too much tone to be allowed in . It makes sense when you say, the program will help reduce my spasticity. I've also been riding FES bike three to four times per week as well as being in standing wheelchair for the past two years, which has helped with spasticity.


    I understand I don't meet the criteria for the clinical trial. Reading about the locomotor training and walking therapy in China brought about my questions concerning NRN locomotor training program here Thanks again, you inspire us to keep fighting!

    Mike
    Mike,

    Hey, you are one of the people on the Fampridine SR trial. I was wondering how you are weaning off the baclofen pump without some other kind of intervention. That is impressive, if you were once at 140 mg/day (that is the max) and received as much as 300 micrograms per day via the pump, to be weaning down to 30 mg/day oral and 130 micrograms/day via pump. Wow, that is great if it is due to Fampridine reducing your spasticity. In theory, it may do that because it increases synaptic neurotransmitter release from voluntary activity.

    I have not been talking to the people at Kessler concerning their walking program and suspect that they want you to lower the baclofen rate until you have sufficient weight-bearing reflexes for the walking. It makes sense. It is interesting that very few of the patients in the walking programs in Kunming, China take baclofen at all. But, they are up and weight-bearing a lot more than the average American with spinal cord injury. Perhaps a combination of daily weight-bearing and the Fampridine will allow you to wean off of Baclofen. I don't know.

    Regarding a trial for high quads, we will eventually have to do a C1-C4 trial. So, we are planning one to start as soon as and if the other trial shows positive results.

    Wise.

  8. #48
    Dr. Young,I was disappointed when they stopped the Fampridine SR trial, I felt I was getting some good benefits. I've been taking compound 4 AP SR for approximately 2 years, that's when I started gradually reducing the oral baclofen from 140 mg to 15 mg as of about two months ago. As for the pump that to has been very gradual over the last year and a half from approximately 300 mcg to about 195 mcg as of about two months ago. I just started to accelerate decreasing the pump over last couple of weeks to 130 mcg. I'm starting to feel a little more spasticity at this point. My next decrease is tomorrow 15%, we'll see what that does.

    To wean off the baclofen, I think it's been a combination of things. I'm able stand-in my wheelchair, FES bike and 4 AP.As for intervention, I may need some other kind at this point to get to that magic number of 0 mg via the pump, as instructed. Have any suggestions? I really want to pass the tone screening at the end of the month to get in the program. I'm hoping that my legs aren't to rigid.
    Last edited by Mike Pell; 05-12-2009 at 06:53 PM. Reason: Correction
    Mike P.

  9. #49
    Senior Member
    Join Date
    May 2004
    Location
    By the beach.
    Posts
    204
    Quote Originally Posted by Wise Young View Post
    I tried to invite Bill Donovan from TIRR to attend the Austin meeting. I also invited Dr. Bob Grossman, the Houston neurosurgeon who is the principal investigator the Christopher and Dana Reeve Foundation sponsored NACTN (North American Clinical Trial Network) to attend our meeting. Unfortunately, neither could come because of the short notice. I will continue to try to involve them.

    Wise.
    Dr. Wise,
    Dr. Donovan is retired and Dr. Grossman I don't know what his role is at TIRR.
    In order to respect the privacy of this person I'll have to private message you the correct contact info. on research director, (with whom I spoke today about the NASCINet and, it didn't look like he was aware of NASCINet.)
    every time you fall,
    stand up tall....
    come back for more

  10. #50
    TIRR was bought by Memorial Hermann Hospital Systems a few years ago.
    Dr. Grossman works at The Methodist Hospital System.
    Two planets in the same universe. Strong but very separate.
    Memorial Hermann may want its own Neurosurgeons involved.
    Memorial Hermann has one of Houston's major trauma hospitals.
    Trauma Hospital plus SCI Rehab Hospital with a NRN program and Lokomat.
    Keep it in the family and you may have a great place to conduct trials.
    Dr. Donovan may be able to recommend one of the younger SCI doctors who wants to make his name.

Posting Permissions

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