ChinaSCINet Update

[Jim]

I have no idea what the ChinaSCINet funding numbers are. All the money was raised in Hong Kong and China.

[lakboy]

Jim, How can you say that it is already a success ? It just shows that it is safe to transplant USBC in the spinal cord, for me success means functional return. Alok Sharma , Carlos Lima have been transplanting cells of different kinds for many many years , so we know that bone , olfactory cells are also safe , but what have the patients gained ?

[Jim]

Establishing a clinical trial network with 26 Centers and conducting a Phase II safety trial which proved to be safe is a huge deal. The fact that this surgery is safe is no trivial matter. Opening the dura and exposing the spinal cord can be risky, now we know it can be done safely. Any return of function is a bonus.

[khmorgan]

Jim, How can you say that it is already a success ? It just shows that it is safe to transplant USBC in the spinal cord, for me success means functional return. Alok Sharma , Carlos Lima have been transplanting cells of different kinds for many many years , so we know that bone , olfactory cells are also safe , but what have the patients gained ?

Unless I missed something, ChinaSCINet is in Phase 2 trials, not Phase 1. By definition, Phase 2 is testing for effectiveness as well as safety. See: http://en.wikipedia.org/wiki/Clinical_trial

In Phase 2 trials, the experimental treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

I would expect that if none of the patients showed any improvement in mobility, they would not move to Phase 3. But, if half showed significant improvement, they might analyze the results more to try to determine if it was a placebo effect or if the procedure needed to be refined. Of course, if all showed improvement, I would expect Phase 3 to proceed quickly.

Regardless, they will learn something that will aid the next treatment's clinical trial.

What confuses me is why people who consider a cure to be a "joke", even read this forum.

[Wise Young]

Jim, How can you say that it is already a success ? It just shows that it is safe to transplant USBC in the spinal cord, for me success means functional return. Alok Sharma , Carlos Lima have been transplanting cells of different kinds for many many years , so we know that bone , olfactory cells are also safe , but what have the patients gained ?

Lakboy,

As you know, Alok Sharma has not transplanted cells into the spinal cord. He has only given the cells intrathecally. Both institutional review boards and government regulatory agencies in India have been very resistant to the concept of surgically exposing the spinal cord to transplant cells into the spinal cord. So, your statement that "we know that bone <marrow>, olfactory cells are also safe" is not accepted in India or most places around the world. From that perspective, the demonstration that the treatments are safe is a critical and necessary step to getting such therapies to be allowed and approved in India and most other countries in the world.

I wish that people would not jump to conclusions about efficacy of umbilical cord blood and lithium before data becomes available. Just because I am not trumpeting the results of not-yet-completed trials does not mean that the treatments are not having beneficial effects. I wish also to remind people that only the 6 month results will be available in December. It is too early to expect dramatic functional results from regeneration.

Wise.

[vaibhavjain]

im sorry i meant nov 2010 not 2012. so that is 2 years of data available isnt it

[Jim]

im sorry i meant nov 2010 not 2012. so that is 2 years of data available isnt it

All the data must be analyzed together and therefore isn't released as it becomes available.

[Jawaid]

Wise results are being waited and also it can be great if cethrin can be added in phase3 trial. Looks cethrin is good candidate for axonal regeneration but yet not proved in chronics.

[Wise Young]

im sorry i meant nov 2010 not 2012. so that is 2 years of data available isnt it

Most clinical trials do not release data until the trials have ended. As a service to the community, we are releasing interim analyses of data when they become available. For example, we released 6-week safety data of the trial this past summer as soon as they were available. Analyses of 6 month followup data will not be available until all the 6-month data has been collected. Yes, some one-year followup data are available from several of the patients who were transplanted before October 2011 but these will not be released until all the one-year data has been collected and analyzed. We do not yet have two-year followup data on any patient.

Wise.

[Wise Young]

Wise results are being waited and also it can be great if cethrin can be added in phase3 trial. Looks cethrin is good candidate for axonal regeneration but yet not proved in chronics.

Cethrin cannot be just "added" to the phase 3 trial. We must conduct phase 1 and 2 trials to show that it can be added safely. Also, it would be helpful to have some efficacy data.

Wise.

[skippopotamus]

Dr. Young, thank you for being patient with us! And for working so hard.

[Jawaid]

Wise u mean if Dr Alok would have transplanted cells into spinal cord results had been different ? Cethrin has already two trials but on acutes not chronics.

Well best of luck to u but it looks some therapy which will give functions to us is still few years away. For lumbosacral it may take some more time.

Let us see what results from Brazil trial who have taken lumbar injury patients. Any thoughts on brazil trial Wise? If bone marrow cells are not effective in lumbar injuries then why brazil taking lumbar injuries in their trial? Already one L1 patients began to walk and got bladder bowel function too.

[kivi66]

Already one L1 patients began to walk and got bladder bowel function too.

Jawaid, may you provide source?

[Jawaid]

Kivi i dont know how to paste link but you can search a thread on CC with Paraplegic move legs after stem cell procedure- Brazilian center of cell therapy.

[Wise Young]

Wise u mean if Dr Alok would have transplanted cells into spinal cord results had been different ? Cethrin has already two trials but on acutes not chronics.

Well best of luck to u but it looks some therapy which will give functions to us is still few years away. For lumbosacral it may take some more time.

Let us see what results from Brazil trial who have taken lumbar injury patients. Any thoughts on brazil trial Wise? If bone marrow cells are not effective in lumbar injuries then why brazil taking lumbar injuries in their trial? Already one L1 patients began to walk and got bladder bowel function too.

Jawaid,

I don't know whether implantation of the bone marrow stromal cells into the spinal cord would be better but an intraspinal injection of cells puts many times more cells into the spinal cord than an intrathecal injection. I don't know what the results of the Brazil trial are.

Wise.