ChinaSCINet Update

[Jim]

http://www.ingentaconnect.com/search...ize=10&index=1

[FellowHawkeye]

[QUOTE=Jim;1815734]http://www.ingentaconnect.com/search...ize=10&index=1[/QUOT

Thanks, that worked!

[ouch]

I just glanced at the results section for the trial that was completed. Where is the video? I would like to see how well these people walk. Also, can they stand, or are they hooked up to some type of harnesses?

[skeaman]

I just glanced at the results section for the trial that was completed. Where is the video? I would like to see how well these people walk. Also, can they stand, or are they hooked up to some type of harnesses?

I too would love to see a video. It
would give us all a great life . For there
is only so much reading we can do . So come guys released a bit off video
footage off the trials

[lunasicc42]

Tbh the amount of silent time on chinascinet has led me to believe that the results are minimal. Of course I hope that my suspiscions are wrong but thats the feeling that I have been getting ...epi-stim has sounded more hopeful for what I am interested in ...arm function return and BBSF return .

[lampros]

oh yes! give us a picture, or a video or an information about the trials, as a little food in our hope...

[tumbleweeds]

I know there's an enormous amount of work being done and am very optimistic about the upcoming trial but I was wondering if the upcoming trials are on schedule, behind schedule or ahead of schedule. And if they are still on schedule for May when would recruiting start?

[Jim]

I just glanced at the results section for the trial that was completed. Where is the video? I would like to see how well these people walk. Also, can they stand, or are they hooked up to some type of harnesses?

The videos are not being released at this time.

I don't know what the participants progress is today but the data from the study had 15/20 walking with at least an upper body supporting rolling walker. These subjects are able to step on their own and go long distances. Of those 15, a few progressed to just a 4 point walker. Several of the participants regained independence performing their bowel routine, some able to go normally. The same with bladder function, many became independent, some were able to stop cathing. (The exact #'s are in the paper). I'm not a fan of bar graphs, do y'all find them easy to translate?

DTI imaging of some subjects showed growth across the injury site and well beyond. (Not all had readable DTI's because of hardware).

Tbh the amount of silent time on chinascinet has led me to believe that the results are minimal. Of course I hope that my suspiscions are wrong but thats the feeling that I have been getting ...epi-stim has sounded more hopeful for what I am interested in ...arm function return and BBSF return .

I know it is taking a long time, but that has nothing to do with the results. This Phase II study was done in our clinical trial network in China. In 2016 we had a Pre-IND meeting with the US FDA. They required us to do an additional safety study, one at our lab, another repeated at a GMP Certified facility. There was a long delay before we were able to start. Once we were able to, our part was done quickly (60 rats). There was another delay before the GMP facility was able to begin. (There's one GMP facility in the US that can perform the rat SCI contusion model). We are now waiting for their results. We will then meet with the FDA and seek final approval. This process is very difficult , and VERY expensive. The study at the GMP facility alone was north of 500K, which StemCyte picked up.

This was a phase II safety study from which we learned a great deal. If these results are repeated in India, Taiwan, and the US, we have a solid therapy that converts completes to incompletes. Gaining independence is a huge deal. Next, we go ahead with the next most promising therapy.

I know there's an enormous amount of work being done and am very optimistic about the upcoming trial but I was wondering if the upcoming trials are on schedule, behind schedule or ahead of schedule. And if they are still on schedule for May when would recruiting start?

There is still much to do, I'm not sure how long until we can meet with the FDA. Nothing can o forward until we get approval. When I know more I'll post.

All news about the Trial is shared via eBulletin. If you want me to add you, give me your email here or send to jimbenn@rutgers.edu.

[lunasicc42]

The videos are not being released at this time.

I don't know what the participants progress is today but the data from the study had 15/20 walking with at least an upper body supporting rolling walker. These subjects are able to step on their own and go long distances. Of those 15, a few progressed to just a 4 point walker. Several of the participants regained independence performing their bowel routine, some able to go normally. The same with bladder function, many became independent, some were able to stop cathing. (The exact #'s are in the paper). I'm not a fan of bar graphs, do y'all find them easy to translate?

DTI imaging of some subjects showed growth across the injury site and well beyond. (Not all had readable DTI's because of hardware).



I know it is taking a long time, but that has nothing to do with the results. This Phase II study was done in our clinical trial network in China. In 2016 we had a Pre-IND meeting with the US FDA. They required us to do an additional safety study, one at our lab, another repeated at a GMP Certified facility. There was a long delay before we were able to start. Once we were able to, our part was done quickly (60 rats). There was another delay before the GMP facility was able to begin. (There's one GMP facility in the US that can perform the rat SCI contusion model). We are now waiting for their results. We will then meet with the FDA and seek final approval. This process is very difficult , and VERY expensive. The study at the GMP facility alone was north of 500K, which StemCyte picked up.

This was a phase II safety study from which we learned a great deal. If these results are repeated in India, Taiwan, and the US, we have a solid therapy that converts completes to incompletes. Gaining independence is a huge deal. Next, we go ahead with the next most promising therapy.



There is still much to do, I'm not sure how long until we can meet with the FDA. Nothing can o forward until we get approval. When I know more I'll post.

All news about the Trial is shared via eBulletin. If you want me to add you, give me your email here or send to jimbenn@rutgers.edu.

Thanks for the post

[lampros]

dear Jim, please feel free to add me in eBulletin, so i will be able to follow any news. (zoipist@gmail.com and hstagou@yahoo.gr). Thanks in advance.

[Barrington314mx]

The videos are not being released at this time.

Is there a particular reason why not? Much of the "other studies" show some sort of video.
Wasn't there a video awhile back showing the walking PT portion?

[Nowhere Man]

The videos are not being released at this time.

I don't know what the participants progress is today but the data from the study had 15/20 walking with at least an upper body supporting rolling walker. These subjects are able to step on their own and go long distances. Of those 15, a few progressed to just a 4 point walker. Several of the participants regained independence performing their bowel routine, some able to go normally. The same with bladder function, many became independent, some were able to stop cathing. (The exact #'s are in the paper). I'm not a fan of bar graphs, do y'all find them easy to translate?

DTI imaging of some subjects showed growth across the injury site and well beyond. (Not all had readable DTI's because of hardware).



I know it is taking a long time, but that has nothing to do with the results. This Phase II study was done in our clinical trial network in China. In 2016 we had a Pre-IND meeting with the US FDA. They required us to do an additional safety study, one at our lab, another repeated at a GMP Certified facility. There was a long delay before we were able to start. Once we were able to, our part was done quickly (60 rats). There was another delay before the GMP facility was able to begin. (There's one GMP facility in the US that can perform the rat SCI contusion model). We are now waiting for their results. We will then meet with the FDA and seek final approval. This process is very difficult , and VERY expensive. The study at the GMP facility alone was north of 500K, which StemCyte picked up.

This was a phase II safety study from which we learned a great deal. If these results are repeated in India, Taiwan, and the US, we have a solid therapy that converts completes to incompletes. Gaining independence is a huge deal. Next, we go ahead with the next most promising therapy.

Can you elaborate? Why would you move on to a new therapy after having phase II trial results that are better than any other therapy out there. I mean long distance spinal cord regeneration in chronic sci...no other therapy in the lab can do that. Wouldn't it make sense to just keep tweaking the UCB+lithium+Meth concoction, refining it, to get better and better results?

[Jim]

Hey NM, I meant we will move forward if this therapy is confirmed to work, the clinical trial process is completed, and the therapy is approved by the FDA. Tweaking, def. The data suggests lithium & methylprednisolone are not effective, if confirmed in the next Phase II's, they will be dropped.

We are working hard on Muse cells (pluripotent, umbilical cord blood cells.) It is possible they may be more effective than mononuclear cells. We are also trying them in the lumbosacral injury model.

[Barrington314mx]

We are working hard on Muse cells (pluripotent, umbilical cord blood cells.)

Is this what has already been submitted to FDA? Or will that require a separate application and study?

[Jawaid]

Good question by Barrington314mx.
Jim please keep updated about lumbosacral studies.