ChinaSCINet Update

[crabbyshark]

Dr. Wise,

How's the clinical trial network coming along?

[Wise Young]

crabbyshark, we just finished a week long workshop training people from China to do cell processing for the clinical trial in China. I am trying to get all the paper done. Wise.

[Wise Young]

I am sorry but the database transfer missed several months of posts in these sticky topics. Steven Edwards tells me that the posts are not lost and he is working on getting these posts to show. Wise.

[JamesMcM]

Hey Wise, I have a few questions for you. First how approval going with the FDA, everything on schedule still looking to begin trial in Q3 this year, also I remember you mentioning you were looking for methods to train functional hand movements along with walking program, have you found something that will provide the proper stimulation to support recovery?

[Chaz19]

I'm with James and very interested in the methods for training functional hand movements. Looking forward to your thoughts and ideas. Thanks Dr. Young.

[Wise Young]

Hey Wise, I have a few questions for you. First how approval going with the FDA, everything on schedule still looking to begin trial in Q3 this year, also I remember you mentioning you were looking for methods to train functional hand movements along with walking program, have you found something that will provide the proper stimulation to support recovery?

We are still preparing the IND. I am writing the manuscripts and working on getting the IND going in China (transferring cell processing technology to China). We just completed a workshop, training people from three centers in China to do the cell processing. We have also developed a new processing protocol which allows mononuclear cells to be isolated from both plasma-depleted and red-cell-depleted cord blood units. Regarding hand exercise, I have been evaluating hand function scores and talking to a company called Bioness, to include a hand stimulator as part of the exercise routine for people who have cervical spinal cord injury in our trials. Wise.

[#LHB#]

Is it just taking longer than you thought or are you running into roadblocks in the US regarding the approval with the FDA? Are you seeing any change in hand function in those you evaluated?

[paolocipolla]

I am sorry but the database transfer missed several months of posts in these sticky topics. Steven Edwards tells me that the posts are not lost and he is working on getting these posts to show. Wise.

I have saved some posts in the past, in case something gets lost permanently i'll be happy to help if i can.

Paolo

[paolocipolla]

We are still preparing the IND. I am writing the manuscripts and working on getting the IND going in China (transferring cell processing technology to China). We just completed a workshop, training people from three centers in China to do the cell processing. We have also developed a new processing protocol which allows mononuclear cells to be isolated from both plasma-depleted and red-cell-depleted cord blood units. Regarding hand exercise, I have been evaluating hand function scores and talking to a company called Bioness, to include a hand stimulator as part of the exercise routine for people who have cervical spinal cord injury in our trials. Wise.

When do you plan to have the IND ready?
Is there any Principal Investigator (PI) helping you getting things ready?

Paolo

[allenstevens]

Another 6 months & the data will be out

[JamesMcM]

Bioness interesting. I have used that at my clinic defiantly the best option, Tryomotion also has some interesting equipment for the hands. So the phase III trial will have a different potentially more beneficial method of processing the cell then the previous phase II trial? My apologies if you've already answered this but has anything formal been submitted to the US, FDA?

[JamesMcM]

We're did you get that timeline?

[JamesMcM]

We're did you get that timeline?

Another 6 months & the data will be out

Were did you get that timeline?

[Wise Young]

Is it just taking longer than you thought or are you running into roadblocks in the US regarding the approval with the FDA? Are you seeing any change in hand function in those you evaluated?

No, there have been no roadblocks, just a lot of work. Wise.

[Wise Young]

Bioness interesting. I have used that at my clinic defiantly the best option, Tryomotion also has some interesting equipment for the hands. So the phase III trial will have a different potentially more beneficial method of processing the cell then the previous phase II trial? My apologies if you've already answered this but has anything formal been submitted to the US, FDA?

We have to have all the documentation for the cell processing and the clinical trial safety data. I am writing the papers and putting together the documents. Wise.