Announcement

Collapse
No announcement yet.

Spinal Cord Injury Network USA (SCINetUSA)

Collapse
This is a sticky topic.
X
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

    Originally posted by havok View Post
    Is Cethrin still going to be used as a chronic trial or acute like the original cethrin trials?
    We are hoping to try chronic but much depends on the results of animal studies. Wise.

    Comment


      an update professor




      Originally posted by Wise Young View Post
      We are still hoping to get that trial going in Brackenridge Hospital in Texas. However, much depends whether we are able to find appropriate principal investigators for that trial.

      In the meantime, we are planning to start a clinical trial in New Jersey.

      Wise.

      Comment


        I really dont understand the hold up. "results from china"? Did Geron or Invivo or Miami project have results from china to give to the FDA? And i know you are going to say funding. But does anyone even know how much has or still needs to be funded? All i hear is "we need 2 million, or about 100k per patient". Sooo still need the full 2 million or has 1/4 of it been raised? You dont owe anyone anything, and i greatly appreciate the work you are doing, but something feels missing and not complete or in the dark.

        Comment


          We are still hoping to get that trial going in Brackenridge Hospital in Texas. However, much depends whether we are able to find appropriate principal investigators for that trial.

          In the meantime, we are planning to start a clinical trial in New Jersey.

          Wise.


          pr when it will start ?

          Comment


            Originally posted by fti View Post
            We are still hoping to get that trial going in Brackenridge Hospital in Texas. However, much depends whether we are able to find appropriate principal investigators for that trial.

            In the meantime, we are planning to start a clinical trial in New Jersey.

            Wise.


            pr when it will start ?
            I am sorry but we don't know yet. Wise.

            Comment


              and clinical trial phases 2 austin is abandoned?

              Comment


                Originally posted by Barrington314mx View Post
                I really dont understand the hold up. "results from china"? Did Geron or Invivo or Miami project have results from china to give to the FDA? And i know you are going to say funding. But does anyone even know how much has or still needs to be funded? All i hear is "we need 2 million, or about 100k per patient". Sooo still need the full 2 million or has 1/4 of it been raised? You dont owe anyone anything, and i greatly appreciate the work you are doing, but something feels missing and not complete or in the dark.
                Barrington314mx,

                Let me fill in some of the "dark" for you. I usually don't like to complain or talk about the work that we do but it might help for me to explain what we have to do to get these trials going.

                We are applying for an IND (Initial New Drug/Device application) to do a phase II and a phase III trial in the U.S. You don't get these approved until you have submitted all safety and other data from phase I/II trials. Geron, In Vivo, and Miami Project were/are phase I trials to assess safety of their therapies. To get phase II and phase III approval, you have to submit all the safety and efficacy data that you have collected to date. The key to fast approval is having all the data that the FDA needs to approve an application. I hope that we can get ours much faster because we have human data from the ChinaSCINet.

                We have been waiting for our 6 month data from the phase II trial in China. Our teams are now out in the field, travelling to the patients' homes to examine them. It takes time to enter and validate the data against paper records and do the analysis. IND's are not not just ten-page applications. IND applications involve thousands of pages of safety and efficacy data. It takes drug companies with dozens of experienced regulatory staff many months to compile one IND application. I plan to spend Christmas and New Years working on this and hope to submit the IND to the U.S. FDA and other regulatory agencies before the end of January.

                We are working hard on fundraising. I submitted a grant to the DOD For the UCBMC+lithium┬▒Cethrin phase II in New Jersey but it did not make the final cut. I am talking to foundations and companies. We are collecting through JustADollarPlease.Org. We need to raise $6.4 million for the Phase III trial in the U.S, $2.4 million for the Phase II in New Jersey, $2.1 million for the Phase II in Brackenridge, $1.4 million in Hong Kong for ChinaSCINet, and $1.2 million in India for SCINetIndia trial. We are planning fundraisers with Boyd Melson in New York, as well as a televised fundraiser in Hong Kong. Details will be posted as soon as we know.

                I understand your impatience. However, please put what we are trying to do in context. Geron took 4 years to get their first IND approved by the FDA in the U.S. They did not complete their phase I trial. Both In Vivo Therapeutics and Miami Project have not yet received approval of their IND applications for Phase I trials. Stem Cell Inc. is doing a phase I trial in Switzerland and NeuralStem has been doing phase I trials on ALS in Atlanta for the past year. Novartis has done phase I/II studies of Nogo antibody over the last 5 years. Each spent many millions of dollars but none are even close to Phase III.

                By comparison, since 2006, ChinaSCINet has completed three clinical trials (one observation trial, one phase I lithium trial, and one phase II lithium trial). We are doing a multicenter phase II trial (assessing increasing doses of umbilical cord blood mononuclear cells, combined with methylprednisolone and lithium). We are planning a global phase III trial in China, U.S., Norway, and India for 2013. We are applying to regulatory authorities and raising money for clinical trials in multiple countries. Trial costs are supported by donations from people, Stemcyte, and government grants.

                We are doing all of this with only three paid staff in Hong Kong and two part-time staff at Rutgers. The rest are volunteers, like myself. Most of the people who are doing these trials, including the doctors and nurses who actually run the trials, have other full-time jobs to do. I am incredibly proud and profoundly grateful to our doctors and nurses in Hong Kong and Kunming for their hard work to make these trials a reality. I am also humbled by the service of the people who have volunteered their bodies for these clinical trials. And, of course, I thank the thousands of people who have raised money and donated to these trials.

                Wise.
                Last edited by Wise Young; 8 Dec 2012, 8:52 AM.

                Comment


                  Originally posted by fti View Post
                  and clinical trial phases 2 austin is abandoned?
                  No, we are continuing to work on getting the trial going. Wise.

                  Comment


                    Professor in france there is no way to mount a network of clinical trials?

                    Comment


                      Originally posted by Wise Young View Post
                      Barrington314mx,

                      Let me fill in some of the "dark" for you. I usually don't like to complain or talk about the work that we do but it might help for me to explain what we have to do to get these trials going.

                      We are applying for an IND (Initial New Drug/Device application) to do a phase II and a phase III trial in the U.S. You don't get these approved until you have submitted all safety and other data from phase I/II trials. Geron, In Vivo, and Miami Project were/are phase I trials to assess safety of their therapies. To get phase II and phase III approval, you have to submit all the safety and efficacy data that you have collected to date. The key to fast approval is having all the data that the FDA needs to approve an application. I hope that we can get ours much faster because we have human data from the ChinaSCINet.

                      We have been waiting for our 6 month data from the phase II trial in China. Our teams are now out in the field, travelling to the patients' homes to examine them. It takes time to enter and validate the data against paper records and do the analysis. IND's are not not just ten-page applications. IND applications involve thousands of pages of safety and efficacy data. It takes drug companies with dozens of experienced regulatory staff many months to compile one IND application. I plan to spend Christmas and New Years working on this and hope to submit the IND to the U.S. FDA and other regulatory agencies before the end of January.

                      We are working hard on fundraising. I submitted a grant to the DOD For the UCBMC+lithium┬▒Cethrin phase II in New Jersey but it did not make the final cut. I am talking to foundations and companies. We are collecting through JustADollarPlease.Org. We need to raise $6.4 million for the Phase III trial in the U.S, $2.4 million for the Phase II in New Jersey, $2.1 million for the Phase II in Brackenridge, $1.4 million in Hong Kong for ChinaSCINet, and $1.2 million in India for SCINetIndia trial. We are planning fundraisers with Boyd Melson in New York, as well as a televised fundraiser in Hong Kong. Details will be posted as soon as we know.

                      I understand your impatience. However, please put what we are trying to do in context. Geron took 4 years to get their first IND approved by the FDA in the U.S. They did not complete their phase I trial. Both In Vivo Therapeutics and Miami Project have not yet received approval of their IND applications for Phase I trials. Stem Cell Inc. is doing a phase I trial in Switzerland and NeuralStem has been doing phase I trials on ALS in Atlanta for the past year. Novartis has done phase I/II studies of Nogo antibody over the last 5 years. Each spent many millions of dollars but none are even close to Phase III.

                      By comparison, since 2006, ChinaSCINet has completed three clinical trials (one observation trial, one phase I lithium trial, and one phase II lithium trial). We are doing a multicenter phase II trial (assessing increasing doses of umbilical cord blood mononuclear cells, combined with methylprednisolone and lithium). We are planning a global phase III trial in China, U.S., Norway, and India for 2013. We are applying to regulatory authorities and raising money for clinical trials in multiple countries. Trial costs are supported by donations from people, Stemcyte, and government grants.

                      We are doing all of this with only three paid staff in Hong Kong and two part-time staff at Rutgers. The rest are volunteers, like myself. Most of the people who are doing these trials, including the doctors and nurses who actually run the trials, have other full-time jobs to do. I am incredibly proud and profoundly grateful to our doctors and nurses in Hong Kong and Kunming for their hard work to make these trials a reality. I am also humbled by the service of the people who have volunteered their bodies for these clinical trials. And, of course, I thank the thousands of people who have raised money and donated to these trials.

                      Wise.
                      Wise,

                      if the phase I/II in China is not indicating any significant functional recovery (as it seems, but i give you the benefit of the doubt), why would you waste time and money doing another phase I/II in the US?

                      I would skip doing UCB + Li in the US and work hard to get something more promising ready ASAP for clinical trials.

                      Paolo
                      In God we trust; all others bring data. - Edwards Deming

                      Comment


                        I apologize Wise. Thanks for again making things more clear. I guess it just got frustrating when i went back through the threads and see that things just keep getting delayed. When in reality, its still going quite smooth.

                        Comment


                          Originally posted by paolocipolla View Post
                          Wise,

                          if the phase I/II in China is not indicating any significant functional recovery (as it seems, but i give you the benefit of the doubt), why would you waste time and money doing another phase I/II in the US?

                          I would skip doing UCB + Li in the US and work hard to get something more promising ready ASAP for clinical trials.

                          Paolo
                          Paolo,
                          I really tought that people from spain was more respectful than you have shown lately.
                          Can't you wait a couple of weeks for the 6 month data and stop being mr. Negative?
                          Originally posted by paolocipolla
                          Moe,

                          I... don't care about what I think ... you should just ignore my posts.

                          I don't understand ... words.

                          Paolo

                          Comment


                            Originally posted by Solan View Post
                            Paolo,
                            I really tought that people from spain was more respectful than you have shown lately.
                            Can't you wait a couple of weeks for the 6 month data and stop being mr. Negative?
                            6 month is 180 days, the nerves will grow 18 cm (1 mm a day), I'm afraid he will be more irritated after reading the 6 month results.

                            Comment


                              Originally posted by Barrington314mx View Post
                              I apologize Wise. Thanks for again making things more clear. I guess it just got frustrating when i went back through the threads and see that things just keep getting delayed. When in reality, its still going quite smooth.
                              I don't think you have something to apologize for.

                              Looking at the situation with common sense any person would say what you said in your post #363 IMO.

                              Sometimes an eccess of reverences may affect objectivity.

                              Paolo
                              In God we trust; all others bring data. - Edwards Deming

                              Comment


                                Originally posted by Solan View Post
                                Paolo,
                                I really tought that people from spain was more respectful than you have shown lately.
                                Can't you wait a couple of weeks for the 6 month data and stop being mr. Negative?
                                I am optimist, in fact I give Wise the benefit of the doubt.

                                Paolo
                                In God we trust; all others bring data. - Edwards Deming

                                Comment

                                Working...
                                X