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  • Hey dude. Check out the following sites:

    http://www.justadollarplease.org/

    & www.chinascinet.org

    and the video on this one has an interview with Wise in it explaining the goings on which is a decent summary.

    http://www.ibelieveinc.org/

    Im sure Jim will pipe up soon with more useful info

    Fly Pelican Fly

    Comment


    • Thanks FPF.

      Sorry enginerd, didn't see this.

      I believe funding has been secured for the China trial. As of last week they were still recruiting patients.

      I'm not sure if all the funds have been raised for the SCINetUSA Phase 2 Trial at Brackenridge Hospital in Austin Texas.

      The China trial will start, then U.S.



      The SCINetUSA Phase 3 Trial is what we are raising money for now. This trial will cost in the neighborhood of $32 million and much of the money will be raised by the participating centers. The JustADollarPlease Campaign is how we hope to raise a great deal of money. We are asking those with SCI and their families and friends to donate $1 dollar per day.

      We have completed a new JADP website and will be launching this campaign in the coming weeks.

      Comment


      • Originally posted by Johnnie Walker View Post
        Dr. wise thank you verry much of your answer.

        Do you know if ChinaSCInet are doing clinical treatments on people like China stem cell company at Shenzhen of is not the same ? en what do you think of this treatments at China stem cell company at Shenzhen are the good ?
        Johnnie, I am so sorry that I did not see your post earlier. ChinaSCINet does clinical trials. We do not charge patients for the treatment. We have nothing to do with the Beike Biotech company in Shenzhen who charges patients for treatments. Wise.

        Comment


        • Originally posted by enginerd View Post
          I'm surprised that no one has responded since my last post. No body has this information? When I approach potential donors, should I just say say that we need to raise money? Maybe I'm not looking in the right places on here, but I need to have some more information if I am going to help push the fundraising efforts.
          Enginerd,

          There have been many discussions of the trials being carried out by ChinaSCiNet and SCINetUSA. Many of the trials are still being planned and depend on the result of the ongoing trials.

          ChinaSCINet is carrying out five trials. All the trials are and will be announced on http://www.clinicaltrials.gov before they commence.
          CN101. Phase 1 Lithium. This trial was completed in Hong Kong and will soon be published. A total of 20 subjects with chronic spinal cord injury received lithium daily for 6 weeks, after the dose has been titrated produce 0.6-1.0 mM serum lithium levels. The subjects are carefully monitored for any adverse events or damage to their organs, neurological function, neuropathic pain, and spasticity. Although 7 subjects voluntarily dropped out of the trial during the first few weeks, none of these or other subjects had toxic levels (i.e. >1.0 mM serum levels) or any objective evidence of organ damage or neurological changes. We concluded that the treatment is safe. http://www.clinicaltrials.gov/ct2/show/NCT00431171
          CN102A. Phase 2 Lithium. This trial is being carried out in two centers. One center is the China Rehabilitation Research Center (CRRC) where 40 subjects with chronic spinal cord injury were randomized to lithium or placebo. In the lithium group, the dose of lithium was increased every 3 days until subjects had 0.6-1.0 mM serum lithium levels and the treatment was continued for 6 weeks. The subjects were assessed at 6 weeks and 6 months for neurological function, pain (visual analog scale) and spasticity. We found no significant effect of the 6-week lithium treatment on neurological function. Another 20 subjects have been randomized to lithium or placebo in the Tzu Chi Buddhist Hospital in Taichong in Taiwan. In the CRRC trial, subjects in the lithium treatment group unexpectedly had a significant decline in their visual analog pain score at 6 weeks and 6 months. We are now planning a trial to confirm this finding in CRRC and Tzuchi Hospitals in Taiwan.
          CN102B. Phase 2 UCBMC transplants, MP, lithium trial. . This trial assesses safety, feasibility, and efficacy of increasing doses of UCBMC from 1.6, 3.2, and 6.4 million cells, and then the highest "safe" dose of cells plus a bolus dose (30 mg/kg iv) of methylprednisolone (MP) at the time of transplant, and then the highest "safe" dose of the cells plus MP, and a 6-week course of lithium. The trial began in January 2010. The trial will recruit 20 subjects to the study, randomize the subjects to the five treatment groups (4 subjects each). The study is being carried out by the University of Hong Kong and the Chinese University of Hong Kong. Subjects will be assessed closely during the week after the transplant, then 6 weeks, and 6 months later. We are still recruiting subjects for this trial and hope that the treatment phase of the trial can begin in June. http://www.clinicaltrials.gov/ct2/show/NCT01046786
          CN103. Phase 3 UCBMC transplants randomized to lithium or placebo.. This trial will start upon completion of CN102B showing the safe dose of transplant and combination of transplant with methylprednisolone or lithium. Depending on the results of CN102B, we will transplant 1.6, 3.2, or 6.4 million cell dose transplanted into the spinal cord of 400 subjects with chronic spinal cord injury and randomize the subjects to a 6 week course of lithium or placebo. The lithium will be titrated to 0.6-1.0 mM serum levels. The subjects will be followed up at 6 weeks, 6 months, and one year. The rehabilitation protocol is still under discussion.

          The SCINetUSA is a clinical trial network in the United States. We are planning four clinical trials.
          US102A. Phase 2 UCBMC plus MP and lithium. This trial is being planned. It will be carried out at the Brackenridge Hospital in Austin, Texas. The goal of the trial is to establish the safety and feasibility of transplanting UCBMC, MP, and lithium to subjects with chronic spinal cord injury, followed by 3-6 months of rehabilitation. This will be in 20 adult subjects (age 17-64).
          US102B. Phase 2 UCBMC plus MP and lithium in older adults. This trial is being planned and will assess the UCBMC plus MP and lithium in 10-20 older subjects (65-80 years old).
          US102C. Phase 2 UCBMC plus MP and lithium in children. We are planning a phase 2 UCBMC plus MP and lithium trial at Shriners Hospital in Philadelphia in children (age 8-17 years old).
          US103. Phase 3 UCBMC, lithium, and locomotor training. We are planning phase 3 trial were 240 subjects are randomized to rehabilitation only, lithium plus rehabilitation, UCBMC plus rehabilitation, and UCBMC plus lithium and rehabilitation.

          I must emphasize that the many of the trials are in the planning phase and depend on the results of previous trials and fundraising. As we find out information from the trials, we may plan additional trials.

          Wise.

          Comment


          • Dont worry DOC. You're busy enough
            keep (rolling) Walking

            Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

            Comment


            • Originally posted by Wise Young View Post
              Enginerd,

              The SCINetUSA is a clinical trial network in the United States. We are planning four clinical trials.
              US102A. Phase 2 UCBMC plus MP and lithium. This trial is being planned. It will be carried out at the Brackenridge Hospital in Austin, Texas. The goal of the trial is to establish the safety and feasibility of transplanting UCBMC, MP, and lithium to subjects with chronic spinal cord injury, followed by 3-6 months of rehabilitation. This will be in 20 adult subjects (age 17-64).
              US103. Phase 3 UCBMC, lithium, and locomotor training. We are planning phase 3 trial were 240 subjects are randomized to rehabilitation only, lithium plus rehabilitation, UCBMC plus rehabilitation, and UCBMC plus lithium and rehabilitation.

              I must emphasize that the many of the trials are in the planning phase and depend on the results of previous trials and fundraising. As we find out information from the trials, we may plan additional trials.

              Wise.
              If I were able to participate in the US102A trial, would that limit my availability for future trials?
              T5/6, ASIA A, injured 30 Nov 08
              Future SCI Alumnus.
              I don't want to dance in the rain, I want to soar above the storm.

              Comment


              • Originally posted by mcferguson View Post
                If I were able to participate in the US102A trial, would that limit my availability for future trials?
                Mcferguson, I of course cannot speak for clinical trials that other investigators are carrying out and whether or not they will exclude subjects that have participated in other clinical trials. Participation in our clinical trial may preclude you from other clinical trials. However, I can speak for myself and the trials that I organize. SCINetUSA will be committed to the following principles for people who have already participated in our trials.

                1. If a trial shows that one therapeutic arm is effective and the other arms are not, we will do our very best to ensure that people who were randomized to non-effective arms of a trial will receive the effective treatment.

                2. We will design and plan clinical trials for those people who have participated in our clinical trial. A therapy may not be the cure for everybody and people are likely to need further therapy.

                3. We will tell people who ask what therapy they have received when the trials are over, if the therapy was masked (i.e. double-blind).

                Wise.

                Comment


                • If I may ask, why is the injury level of recruits limited to lower quads and paras? I can guess, but I'm curious about the specific decision for this trial. Thanks!

                  Comment


                  • Originally posted by Scaper1 View Post
                    If I may ask, why is the injury level of recruits limited to lower quads and paras? I can guess, but I'm curious about the specific decision for this trial. Thanks!
                    Scaper1, we will be injecting cells into the spinal cord above and below the injury site. People who have a C4 level would require injection of the cells into the C3 or C4 segment. The phrenic nerve is in that part of the spinal cord and injections of cells into this part of the spinal cord may compromise respiration.

                    We are planning a trial for high quads (C1-C4) if the current trials show beneficial effects but modify the procedure so that the cells are injected into the injury site and on the caudal edge of the injury site. I think that this would be safer.

                    Wise.

                    Comment


                    • Originally posted by Wise Young View Post
                      Scaper1, we will be injecting cells into the spinal cord above and below the injury site. People who have a C4 level would require injection of the cells into the C3 or C4 segment. The phrenic nerve is in that part of the spinal cord and injections of cells into this part of the spinal cord may compromise respiration.

                      We are planning a trial for high quads (C1-C4) if the current trials show beneficial effects but modify the procedure so that the cells are injected into the injury site and on the caudal edge of the injury site. I think that this would be safer.

                      Wise.
                      what do you hope to accomplish?

                      Comment


                      • Originally posted by Wise Young View Post
                        Scaper1, we will be injecting cells into the spinal cord above and below the injury site. People who have a C4 level would require injection of the cells into the C3 or C4 segment. The phrenic nerve is in that part of the spinal cord and injections of cells into this part of the spinal cord may compromise respiration.

                        We are planning a trial for high quads (C1-C4) if the current trials show beneficial effects but modify the procedure so that the cells are injected into the injury site and on the caudal edge of the injury site. I think that this would be safer.

                        Wise.
                        would you accept a c4c5 incomplete walking quad?
                        "I'm manic as hell-
                        But I'm goin' strong-
                        Left my meds on the sink again-
                        My head will be racing by lunchtime"

                        <----Scott Weiland---->

                        Comment


                        • Hey Dr Wise

                          Just wondering are there any trials coming to Australia or New Zealand, details would be greatly appreciated on behalf of a c3/c4 quad... ; )
                          How does a blade of grass thank the sun?

                          Comment


                          • Originally posted by Wise Young View Post
                            Mcferguson, I of course cannot speak for clinical trials that other investigators are carrying out and whether or not they will exclude subjects that have participated in other clinical trials. Participation in our clinical trial may preclude you from other clinical trials. However, I can speak for myself and the trials that I organize. SCINetUSA will be committed to the following principles for people who have already participated in our trials.

                            1. If a trial shows that one therapeutic arm is effective and the other arms are not, we will do our very best to ensure that people who were randomized to non-effective arms of a trial will receive the effective treatment.

                            2. We will design and plan clinical trials for those people who have participated in our clinical trial. A therapy may not be the cure for everybody and people are likely to need further therapy.

                            3. We will tell people who ask what therapy they have received when the trials are over, if the therapy was masked (i.e. double-blind).

                            Wise.
                            Thanks. That's good to know. I'll be saving up my vacation and sick time.
                            T5/6, ASIA A, injured 30 Nov 08
                            Future SCI Alumnus.
                            I don't want to dance in the rain, I want to soar above the storm.

                            Comment


                            • Originally posted by DA View Post
                              what do you hope to accomplish?
                              In the CN102B phase 2 trial being conducted in Hong Kong now, we are randomizing patients to five treatment groups, receiving 1.6, 3.2, or 6.4 million umbilical cord blood mononuclear cells (UCBMC), the highest "safe" dose of cells plus a bolus dose of methylprednisolone which improves survival of the cells, and that dose plus methylprednisolone and a 6-week course of lithium which we expect to cause the transplanted cells to proliferate in the spinal cord. If our hypothesis is correct, the escalating doses should not only be safe but should be associated with increasing function improvements in the patients. If so, we will proceed to CN103 in China, which will randomize 400 patients transplanted with UCBMC to a 6-week course of placebo or lithium.

                              Depending on the results of the CN102B, we may proceed with US102A, which would be carried out in the Brackenridge Hospital in Austin, TX. This trial would assess the feasibility of doing the procedure in the U.S. This would be followed by US103, the phase 3 trial to establish efficacy,

                              Wise

                              Comment


                              • Wise, sounds good to me. We're counting on ya.

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