Announcement

Collapse
No announcement yet.

ChinaSCINet Update

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

    Originally posted by fti View Post
    dear professor Young you said to going to make come patient of china has Hong-Kong for finish clinical trial in HK. and after madam poon said in a post would make for ten patient has Hong-Kong and ten the other one has kunming why to have still changed

    sorry for all the questions but this is really interesting

    thank you
    fti,

    Last year, I reported to the board of the Hong Kong SCI Fund and asked them to raise an additional funds to support adding 10 patients from Mainland China. Our clinical trial is based on subjects who have valid Hong Kong ID's, which allows hospital expenses to be covered by the government. Patients who are not Hong Kong residents would not be covered. The cost of surgery, hospitalization, and lodging of the patients would be substantial.

    We also have to ensure that the patients come back for followup studies and the patients have housing in Hong Kong. How do we cover travel and housing of patients to be screened for the study and how we would pay for patients who travel to Hong Kong and stay 2 months for the initial part of the study and then the cost of coming back for their 6 and 12 month followup exams.

    So, we have discussed these issues extensively, including opening up the trial to people from all over the world. In the end, we have decided that the original goal of recruiting a total of 20 patients from Hong Kong is unlikely to be achievable within the coming 3 months. However, the team felt confident that they can recruit another four patients.

    I suggested to the group that they consider just doing the highest dose with MP and lithium, since Kunming has shown the safety of the 16 ┬Áliter injections and methylprednisolone treatment. They agreed to apply to their IRB (institutional Review Board) for permission to do this. In the meantime, Kunming needs to do two more patients in the highest dose group plus MP and lithium.

    This way, we will achieve our objective of having 8 patients in the highest cell dose group with MP and lithium. If this turns out to be safe, we will propose this protocol for the U.S. trial. But, we have to wait for the data. This unfortunately delays our U.S. protocol. However, we are proceeding with the development of the Norway protocol.

    There are always obstacles and unexpected developments in clinical trials. When we started this trial two years ago, we did not have all the money raised and we were uncertain whether the treatment protocol is safe. Now, 39 transplantations later (Kungming has also done 13 transplants into subacute spinal cord injuries besides the 26 transplants into chronic spinal cord injury), we have raised the funds for the phase 2 trial in Hong Kong an Kunming and the trials are going ahead. We must complete the data collection to ensure that the combination of the cell transplants, MP, and lithium are safe.

    We need to see a trend for improvement in the patients before we can proceed to phase 3 trials. Yes, some patients are getting some recovery but we have to confirm these on 6-week, 6-month, and 12-month followup examinations. Finally, of course, we are raising the money for the U.S. trials, preparing for EMA (European) and Norwegian approval of the protocols, and preparing to apply to the U.S. FDA.

    Wise.
    Last edited by Wise Young; 21 Jan 2012, 2:07 PM. Reason: minor grammar correction

    Comment


      All I know is that I am looking forward to a possibility .

      Comment


        Originally posted by keeping on View Post
        Barrington, the thing that stand out above everything else is: the trials in China have been delayed again. From Dr Young's update, it appears that lack of patients is the problem. Now, if we can't get enough patients in China, we're in trouble. At the very least we are in trouble with getting results in many of our lifetimes. The start of trials in the USA are out further and further, no matter who starts them. The Chase trials are only in discussion stages . The application and beging of phase 1 trials are years away. Stem Cell INc are in phase 1 trials in Switzerland. Wise Young's trials in China are dealyed. The beginning of trials in the USA were to begin in 1st quarteer of 2012. We have to be honest with ourselaves and the answer is quite clear. anthony

        Anthony
        Anthony,

        Lack of patients in China is not a problem; there are plenty of people there who are willing to volunteer. In China, we have had to blaze new trails in almost everything that we have done. This is the first trial of cells imported from the United States in China. It is the first cooperative clinical trial network in China that I know of. They started in Kunming in October 2011 an did 18 patients in 3 months.

        Lack of patients in Hong Kong is a problem because there are relatively few people with spinal cord injury in Hong Kong. I suppose that I could have gotten more patients by hyping the therapy but this is not the way we do things. Trust, credibility, and ethical conduct is essential for ChinaSCINet. This is a partnership with the community.

        Lack of volunteers is likely to be a problem for the world. We may have trouble finding 20 patients for a phase 1/2 trial in Norway, France, or the United States. However, this is one of the reasons why we must have networks with multiple centers. Networks is the only way to get the numbers that we need to show therapeutic efficacy.

        Please, I also want to say that I am very grateful to patients who have volunteered to participate in the clinical trials. In Hong Kong, in particular, where there is cradle-to-grave health care, there is really no reason for people to volunteer for trials. Why not wait until the trials show that the treatment is safe and effective? So, I thank those who have volunteered.

        Finally, I am very grateful to the doctors who have given their time, energy, staff, and funds for the trial. Drs. Waisang Poon and Gilbert Leung of CUHK and HKU respectively are incredibly dedicated to the trial. After having seen them operate and take care of their patients, I know that I would put my spinal cord under their knives. They care and hopefully will cure.

        Wise.
        Last edited by Wise Young; 21 Jan 2012, 2:08 PM.

        Comment


          Dr Wise Young
          I would do anything to get into the Networks , I just wish I knew how .
          TY
          GL

          Comment


            Anthony you means chase trials are still few years away? If so then that is really very discouraging for us. We will give up. I was just hoping for chase trial in a year or so

            Comment


              Jawaid, the talks to be had between Case Western, Dr Silver, Acorda, and ISRT are importamt. There is interest by all parites to pursue trials of Chase. Remember, only initial discussions for a tiral. This is why I have encouraged all who are interested to e-mail Acorda and tell them we are watching and waiting. I believe that we have to be part of the process. Imagine frompast process, that applications have to be made with FDA. We all know how that goes. then when starting phase 1 trials; first wrinting the cirteria for the trial, recuriting just the right patietns for the trials, applying the technolgy to the patients, waiting for results for safety, on and on and on. I heard mention that their might be quicker way to get to this point; orphan drug or other means. the best we can do is to be part of the process by letting them know we are watching and waiting. wise Young's trials are taking place in themost populous part of the world with the most spinal injured people. they have 18 patients that they have treated; EIGHTEEN. THE TRIALS THAT WERE DELAYED IN the USA have been delayed even further; as per Wise. Stem Cell Inc has opened up their trials for more people, for their trial in Switzerland. I read where trials for HUMANS for heart attack victims and diabetis have shown positive results. Still not part of therapy at hospitals. They have to expand trials to more test patients. Another year before anything will be certified. News reports almost every month on accomplishments, for animals at this time. Jawaid, that;s how I see it at this time; perhaps some new news will occur soon to give us more real excitement.

              Anthony

              Comment


                Wise, I have no coubt about your sincerity. That is not a question. I see the cirteria you must follow. Your efforts are well documented and you are perhaps the best for getting through the maze of regulations. If anything could change my mind or the minds of pateints will be reporting of results and beiginnign of trials in the US. thanks for all you do for us and humanity in general.

                Anthony

                Comment


                  "Yes, some patients are getting some recovery"
                  "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


                    Anyone know what happened to the site earlier ?
                    www.adventuresofcolinandheather.blogspot.com !

                    Comment


                      I m bit dishearted now by the speed of the things going on. Only hope is wait and see what meeting brings for us. If no trials soon i m going to be hopeless then.

                      Comment


                        Jawaid, we have no other choice but ask questiosn and folllow trials. Wise has said that some recovery is happening; but to what extent. I feel we must ask where our efforts can be most apprecited in getting trials going here is the US/ I can't stress enough of human trials with stem cells in other diesaes or problems. Wise is obviously working hard on his trials. I still do not the whoe story on delays in China. We will hear progress this year but to constantly predict 2013 or further out wil lbe ok for those to come but not for many of us. Let's keeo vigilance and scrutinty to programs going on at this time.

                        Anthony

                        Comment


                          There are plenty of trials you can get involved with outside of the US.
                          www.adventuresofcolinandheather.blogspot.com !

                          Comment


                            Colin, I'm not aware of many clinical trials going on outside the US.

                            There are many "treatments" you can pay for that don't work.

                            Comment


                              I thought the list on u2fp was clinical trials
                              www.adventuresofcolinandheather.blogspot.com !

                              Comment


                                i still would love to know more than, "some" patients are getting "some" recovery.
                                also, if its some patients and some recovery, whats the chances that it could just be the decompression?

                                Comment

                                Working...
                                X