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    Dr Young and all : overview of clinical trials

    dear Dr Young and all,

    Do you have, anywhere , a document giving a short overview of ongoing or planned clinical trial for SCI ?
    Tdelrieu, from the French association, wrote a nice and short report, for information only. I translated it to English and adapted it, as I thought it would be interesting to share with carecure. The purpose is to give an overview of trials without going to 100 pages of posts. Please note that it is focused on clinical trial only and does not include 'experimental treatments' which can be included in another document.
    Please see attached document. I would like to know if the document is complete or if we miss any key info there, or if there is any mistake, or if there is any better overview to be found elsewhere. thank you.
    Looking forward to you reaction.
    kind regards.
    Corinne
    www.endparalysis.org!

    #2
    Corinne,

    There are so many trials that have been planned but have not yet come to reaity that I would put pending trials on a separate list. For example, the Derechi/Feron trial is slated to start in 2-3 years, hardly something that should be listed in a current trials list. The Australian trial has ended and I am not sure what they are planning next. The Raisman trial has not yet started but I think that they are planning to do the transplants for brachial plexus avulsion and not for spinal cord injury. I am not sure that I would call the C4H bone marrow transplants a clinical trial and it has run into trouble in Turkey and this is the first that I have heard of Neuronax. Here are several serious clinical trials that is already underway or should start soon:

    • Aventis HP184. This trial is going on and I understand that they are now planning a second trial.
    • Bioaxone BA120 (Cethrin) trial. This is underway in Canada and U.S. They are giving it during surgery at the subacute phase.
    • Geron embryonic stem cell transplants. This is a phase 1 trial that has been announced by Geron. They have initiated arrangements with Cambrex to produce the cells and have applied for permission to the FDA for the trial.
    • Novartis anti-Nogo trial. They have already started to enroll patients into this trial. Is it true that they are planning to do this only in subacute patients?

    I have reported briefly on clinical trials in China in my posts on the ISCITT symposium in Hong Kong last December. These include:
    • ChinaSCINet. This is a network of about 16 leading spinal cord injury centers in China. Patients are being recruited for 6 month observations and will be randomized to lithium. A trial is being planned for 2007 where the patients will receive umbilical cord blood cell transplants and randomized to lithium or placebo.
    • Fetal olfactory ensheathing glia. These are being transplanted into patients with chronic spinal cord injury by at least three hospitals: Dr. Hungyun Huang's, the Beijing Army General Hospital, and the Sun Yatsen Memorial Hospital in Guangzhou.
    • Fetal Schwann cell transplants. These are being transplanted into patients with subacute (2 weeks) and chronic spinal cord injury. Over 120 patients have received these transplants to date.
    • Intrathecal infusion of autologous bone marrow stem cells. These are being done at the Henan People's Provincial Hospital in Zhengzhou. Over 200 patients have received these cells during the subacute phase.
    • Autologous Schwann cell transplants into people with chronic spinal cord injury. These have been done already in about 10 patients with chronic spinal cord injury at Tienjian University.

    The North American Clinical Trial Network (funded by the Christopher Reeve Foundation) is now recruiting patients but no treatment has been specified. It is not clear yet what they are planning to test.

    All this is just off the top of my head. I will add to this list as I think of more.

    Wise.

    Comment


      #3
      Originally posted by Wise Young
      • ChinaSCINet. This is a network of about 16 leading spinal cord injury centers in China. Patients are being recruited for 6 month observations and will be randomized to lithium. A trial is being planned for 2007 where the patients will receive umbilical cord blood cell transplants and randomized to lithium or placebo.
      Dr.Young,

      Off the top of my head, I previously thought that you posted that these trials were planned for September of this year, did it unfortunately get moved back to 2007?

      Comment


        #4
        Originally posted by zokarkan
        Dr.Young,

        Off the top of my head, I previously thought that you posted that these trials were planned for September of this year, did it unfortunately get moved back to 2007?
        The transplant part of the trial still awaits the establishment of a GMP center and approval by the appropriate regulatory agencies. Things can't happen so fast. We are planning to do a lithium vs. placebo trial in September. Wise.

        Comment


          #5
          Originally posted by Wise Young
          The transplant part of the trial still awaits the establishment of a GMP center and approval by the appropriate regulatory agencies. Things can't happen so fast. We are planning to do a lithium vs. placebo trial in September. Wise.
          Ok. I knew I read something about September, thanks for clearing that up for me.

          Comment


            #6
            Corinne,

            This is a list I have gleaned off the CC forum, which are either in progress or pending. I have another list for acutes.

            Chronics:

            1. King's College London (J. Fawcett / E. Bradbury), England - chondroitinase ABC.
            2. The Miami Project to Cure Paralysis (J. Guest), U.S.A. - human OEG from nasal mucosa combined with Rolipram.
            3. Biogen (S. Strittmatter), U.S.A. - Nogo receptor blocker.
            4. Dept. of Neurological Surgery, University of Louisville (Xiao Ming Xu), U.S.A. - Schwann cells-bridging transplantation combined with GDNF and chondroitinase.
            5. Craig Hospital in Englewood (S. Falci), U.S.A. & Karolinska Institute, Sweden - embryonic stem cells.
            6. The Spinal Cord Society, U.S.A. - OECs combined with adult human stem cells.
            7. The Miami Project to Cure Paralysis (M. Bunge), U.S.A. - Schwann cell transplants combined with cAMP and Rolipram.
            8. The ISRT (G. Raisman), England - autotransplantation of adult olfactory mucosal ensheathing glia.
            9. The Reeve-Irvine Research Center (H. Keirstead), U.S.A. - human embryonic stem cells and human OECs.
            10. NewNeural, Inc. (K. Sugaya), U.S.A. - adult stem cell therapy (human neurons from BMSCs).
            11. StemCells, Inc., U.S.A. - human neural stem cells (hCNS-SC).
            12. The Neurosurgery Clinic (W. Jarmundowicz), Wroclaw, Poland - human OEG.
            13. University of Louisville (F. Roisen), U.S.A. - olfactory ensheathing cells.
            14. Mayo Clinic (A. Windebank, Yaszemski), U.S.A. - Schwann cells loaded into the polymer scaffold combined with neurotrophins (BDNF and NT4).
            15. (A. Ramon-Cueto), Valencia, Spain - olfactory ensheathing cells from bulbus olfactorius.
            16. Drexel University College of Medicine (I. Fischer), Pennsylvania, U.S.A. - neural stem cells: BMSC + skin cells (fibroblasts) combined with growth factors.
            17. Hebrew University, Israel - embryonic stem cells.
            18. NTT Project (J. McDonald), Columbia - using of person's own DNA and embryonic stem cells.
            19. Rathbone, Canada - enteric glial cells.
            20. Neuraxo Biotec - ChordaChron

            Comment


              #7
              Dr Young, Schmecky,
              Thanks a lot for your input. I will try to adapt the overview based on that.

              Regarding dr Young remark on whether to consider some trials as 'clinical trials' or not : is there a global and recognized definition of 'clinical trial' vs 'experimental treatments'. The difference between these 2 is rather clear to me, but is there any global acceptance of it ? For example, C4H and Neuronax have announced they would start clinical trials, which I understand are going to be a totally different phase compared to the 'experimental procedures' they are currently carrying out. May we not assume that those 'clinical trials' will then be conducted in line with some kind of globally accepted principle ?

              Last but not least, given the huge numbers of trials planned, is there not a need for a kind of global co-ordination , rather than regulation [because that would, in contrary, slow down progress and limit initiatives] ? Objectives would be : make sure there is no double work and make sure all necessary synergy and knowledge be used through sufficient communication on global level for quicker progress ? But also inform patients properly in order to protect them.

              Is that not something for the WHO SCI center previously referred to on cc ?

              Of course this is a huge and complex task. Organizing the clinical network on Asian level is already a tremendous progress. The HongKong Symposium was also a great step towards global communication. But should the next step not be thought about already ?
              As mentioned by Leif in a recent post, would it not be already a big progress to put all pieces of the puzzle together ? But does anybody have a look at this global puzzle ? It is most probably not that easy. Not sufficient, but maybe necessary ?

              Dr Young, how do you see that ? How could research/trials be synergized on global level to get quicker results ?
              www.endparalysis.org!

              Comment


                #8
                Let me try to answer your questions:
                Originally posted by Corinne Jeanmaire
                Dr Young, Schmecky,
                Thanks a lot for your input. I will try to adapt the overview based on that.

                Regarding dr Young remark on whether to consider some trials as 'clinical trials' or not : is there a global and recognized definition of 'clinical trial' vs 'experimental treatments'. The difference between these 2 is rather clear to me, but is there any global acceptance of it ? For example, C4H and Neuronax have announced they would start clinical trials, which I understand are going to be a totally different phase compared to the 'experimental procedures' they are currently carrying out. May we not assume that those 'clinical trials' will then be conducted in line with some kind of globally accepted principle ?
                • A clinical trial by definition is one that seeks to ascertain the effect of intervention on specified outcome measures. Studies that are purely epidemiological or just seek to correlate patient parameters with observed outcomes are usually called clinical studies or observational studies. Clinical studies and trials also should specify inclusion/exclusion criteria, outcome measures, and what would constitute adequate test of the hypothesis that an intervention is feasible, safe, and/or efficacious. In many clinical studies being carried out overseas, there do not appear to be any standard outcome. Most rely on just patient testimonies with widely varying standards and critieria for what may be called improvement. From that perspective, I don't think that many of the studies could be called clinical trials. Most don't even report morbidity or mortality. It doesn't mean that we can't learn from them but they would be regarded as the lowest level of clinical evidence.

                Last but not least, given the huge numbers of trials planned, is there not a need for a kind of global co-ordination , rather than regulation [because that would, in contrary, slow down progress and limit initiatives] ? Objectives would be : make sure there is no double work and make sure all necessary synergy and knowledge be used through sufficient communication on global level for quicker progress ? But also inform patients properly in order to protect them.
                • Clinical trials are often not coordinated except through the good will of the people involved. Many trials in fact may be competitive and organizers of clinical trials often don't talk to each other and many companies keep their trials secret or at least parts of their trial secret. I agree with you that there should be better communication and that is one of the reason why we have started the ISCITT symposia. It is, to my knowledge, the only symposium that is dedicated to bringing together as many of the people who are actively carrying out or planning spinal cord injury clinical trials.

                Is that not something for the WHO SCI center previously referred to on cc ?

                Of course this is a huge and complex task. Organizing the clinical network on Asian level is already a tremendous progress. The HongKong Symposium was also a great step towards global communication. But should the next step not be thought about already ?

                As mentioned by Leif in a recent post, would it not be already a big progress to put all pieces of the puzzle together ? But does anybody have a look at this global puzzle ? It is most probably not that easy. Not sufficient, but maybe necessary ?

                Dr Young, how do you see that ? How could research/trials be synergized on global level to get quicker results ?
                • The WHO effort, although laudatory and well-meaning, has not been inclusive of many groups that are doing and planning clinical studies and trials of spinal cord injury therapies. It has also been dominated by mostly "alternative" therapies. It is not easy to organize such meetings and they are expensive. For example, the ISCITT cost over $250,000 to run and over a year of very hard work to organize. Spinal cord injury symposia have also been very difficult to organize because they encompass people from at least several major medical fields that don't often talk to each other: rehabilitation, orthopedics, neurosurgery, neurorehabilitation (neurologists interested in rehabilitation), and neuroscientists/neurotraumatologists. Very few groups have the contacts across all the fields to gather the thought leaders and practitioneers. You should also understand how young this field is. I had helped organize the National (U.S.) Neurotrauma Society in the 1980's and the International Neurotrauma Society in the early 1990's, the first interdisciplinary societies to address specifically the topics of brain and spinal cord injury. Before those societies, there were few or no regular meetings. To be sure, there were occasional sections in Neuroscience, Neurology, Neurosurgery, Orthopedics, and Rehabilitation meetings that addressed spinal cord injury but getting people from all the fields in many countries to make time on their busy meeting schedules to come to an annual meeting is not at all easy. Raising the funds for the meetings is a lot of work. Finally, the organizers of such meetings must resolve language, culture, discipline, and other barriers to communication.

                We are holding our next ISCITT meeting in Guangzhou in November 2006. It would be great if you could come.

                Wise.

                Comment


                  #9
                  Originally posted by Schmeky
                  Corinne,

                  This is a list I have gleaned off the CC forum, which are either in progress or pending. I have another list for acutes.

                  Chronics:

                  1. King's College London (J. Fawcett / E. Bradbury), England - chondroitinase ABC.
                  2. The Miami Project to Cure Paralysis (J. Guest), U.S.A. - human OEG from nasal mucosa combined with Rolipram.
                  3. Biogen (S. Strittmatter), U.S.A. - Nogo receptor blocker.
                  4. Dept. of Neurological Surgery, University of Louisville (Xiao Ming Xu), U.S.A. - Schwann cells-bridging transplantation combined with GDNF and chondroitinase.
                  5. Craig Hospital in Englewood (S. Falci), U.S.A. & Karolinska Institute, Sweden - embryonic stem cells.
                  6. The Spinal Cord Society, U.S.A. - OECs combined with adult human stem cells.
                  7. The Miami Project to Cure Paralysis (M. Bunge), U.S.A. - Schwann cell transplants combined with cAMP and Rolipram.
                  8. The ISRT (G. Raisman), England - autotransplantation of adult olfactory mucosal ensheathing glia.
                  9. The Reeve-Irvine Research Center (H. Keirstead), U.S.A. - human embryonic stem cells and human OECs.
                  10. NewNeural, Inc. (K. Sugaya), U.S.A. - adult stem cell therapy (human neurons from BMSCs).
                  11. StemCells, Inc., U.S.A. - human neural stem cells (hCNS-SC).
                  12. The Neurosurgery Clinic (W. Jarmundowicz), Wroclaw, Poland - human OEG.
                  13. University of Louisville (F. Roisen), U.S.A. - olfactory ensheathing cells.
                  14. Mayo Clinic (A. Windebank, Yaszemski), U.S.A. - Schwann cells loaded into the polymer scaffold combined with neurotrophins (BDNF and NT4).
                  15. (A. Ramon-Cueto), Valencia, Spain - olfactory ensheathing cells from bulbus olfactorius.
                  16. Drexel University College of Medicine (I. Fischer), Pennsylvania, U.S.A. - neural stem cells: BMSC + skin cells (fibroblasts) combined with growth factors.
                  17. Hebrew University, Israel - embryonic stem cells.
                  18. NTT Project (J. McDonald), Columbia - using of person's own DNA and embryonic stem cells.
                  19. Rathbone, Canada - enteric glial cells.
                  20. Neuraxo Biotec - ChordaChron
                  Schmechy you forgot Total Record man!
                  I am not your rolling wheels
                  I am the highway
                  I am not your carpet ride
                  I am the sky
                  I am not your blowing wind
                  I am the lightning
                  I am not your autumn moon
                  I am the night, the night..

                  Comment


                    #10
                    Corrine,
                    I agree with you. We have to organize this mess. We have a bunch of "cure" providers around the world. We have to classify the treatments of each provider.

                    1 "Frankensteins" treatment
                    2 Strickly business treatment
                    3 experimental treatment
                    4 clinical trails

                    we have to know who is who, and what they are doing. can we do this? maybe voting? we need to consider this.

                    lets think about this

                    Comment


                      #11
                      There seems to be so many countries jumping in to the stem cell pool. Who is the current leader in procedure and results so far?

                      Comment


                        #12
                        Originally posted by Stormycoon
                        Schmechy you forgot Total Record man!
                        Schmeky,

                        To my knowledge, of the treatments in your list only the following are actually planning clinical trials, to my knowledge:

                        3. Biogen (S. Strittmatter), U.S.A. - Nogo receptor blocker. [They have several different Nogo receptor blockers.]

                        6. The Spinal Cord Society, U.S.A. - OECs combined with adult human stem cells. [To my knowledge, they are planning to do OEG in New Zealand. I don't know about the United States.]

                        8. The ISRT (G. Raisman), England - autotransplantation of adult olfactory mucosal ensheathing glia. [My best understanding is that they are planning the first trial for brachial plexus avulsion cases]

                        9. The Reeve-Irvine Research Center (H. Keirstead), U.S.A. - human embryonic stem cells and human OECs. [This is the Geron trial]

                        11. StemCells, Inc., U.S.A. - human neural stem cells (hCNS-SC). [I just spoke to the company and they are planning trial in Oregon for Batton's disease. They are interested in spinal cord injury trials, however.]

                        12. The Neurosurgery Clinic (W. Jarmundowicz), Wroclaw, Poland - human OEG. [I think that they are already doing the trial]

                        I don't know about Almudena Ramon-Cueto. She is still going the monkey route right now. I was in Spain and asked about the plans and nobody knew whether there are any solid plans.

                        Lisa McKerracher is no longer with Bioaxone.

                        You missed the Novartis Nogo antibody trial that has started in Switzerland.

                        There are of course all the trials in China which I mentioned below.

                        Brisbane is thinking of continuing their trial.

                        In Korea, there is a bone marrow stem cell transplant trial with CSM-GM.

                        In Taiwan, Henreich Cheng is planning to go ahead with his growth factor cocktail and possibly adding GDNF.

                        Miami Project. Well, as you know... they may come up with something yet.

                        Wise.

                        Comment


                          #13
                          Originally posted by e.t.
                          Corrine,
                          I agree with you. We have to organize this mess. We have a bunch of "cure" providers around the world. We have to classify the treatments of each provider.

                          We have to know who is who, and what they are doing. can we do this? maybe voting? we need to consider this.

                          lets think about this
                          A suggestion had been made many months ago to create some type of "Tracking Treatments" thread. This didn't really work out.

                          I would tentatively suggest that CC members seek out clinical trial activities within their respective countries, their province, or region. We could create a series of questions you could take to the clinicians so your questions would be relevant, organized, consistent, and concise.

                          I would be willing to assist with the quesitons, I feel confident other forum members would as well. I know a little Frech girl, name is Corinne, she probably already has what I have suggested. Additionally she is already doing this in her region, and she has done an outstanding job as well.

                          Just a thought.

                          Comment


                            #14
                            in how long biogen will carry out tests private clinic? francais dans combien de temps biogen fera des éssais clinique?

                            Comment


                              #15
                              Originally posted by Schmeky
                              A suggestion had been made many months ago to create some type of "Tracking Treatments" thread. This didn't really work out.

                              I would tentatively suggest that CC members seek out clinical trial activities within their respective countries, their province, or region. We could create a series of questions you could take to the clinicians so your questions would be relevant, organized, consistent, and concise.

                              I would be willing to assist with the quesitons, I feel confident other forum members would as well. I know a little Frech girl, name is Corinne, she probably already has what I have suggested. Additionally she is already doing this in her region, and she has done an outstanding job as well.

                              Just a thought.

                              Schmeky,

                              I probably travel and talk to most of the people involved several times a year. Most of the stuff about trials is usually just rumor. As you may remember Novartis took nearly 5 years to get to a phase 1 trial. Some companies and investigators may not willing to announce a trial until it is really set up. My advice is that we do not list trials that are being planned but only trials that have actually been announced.

                              People are thinking that promising animal results can lead immediately to a clinical trial. This is not true. It takes an incredible amount of work getting the funding, advisory committees, investigators, IRB, and FDA approvals together.

                              Virtually all the people that you have on your list, for example, have never run a spinal cord injury clinical trial. This includes Strittmatter, Keirstead, Raisman, Fawcett (Bradbury), Ramon-Cueto, Bunge, Sugaya, Roisen, Windebank, Fischer, Rathbone, Xu. The only one in your list with any clinical trial experience is John McDonald.

                              Pharmaceutical companies devote whole departments to setting up clinical trials and they outsource a great deal of it. Anybody who has organized a clinical trial knows what I mean. It is an all-consuming and very expensive undertaking.

                              Wise.

                              Comment

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