ChinaSCINet Update

[KofQ]

Dr. Young, I have some more questions When you have time.

1. Is Dr. Zhu (or anyone else) doing a rehab-only control to contrast with the Intradural decompression studies?

2. Are any of the patients in your acute/subacute trials getting intradural decompression?

3. Will your published results of the China trials contain both chronic and acute data, and will they be presented discretely?

4. I believe that your U.S. trials have a rehabilitation only arm. Will the FDA (or anyone else) continue to mandate this in future trials? Repeatedly proving that rehab alone will not get a chronic ASIA A walking again seems a waste of resources.

5. Will the trials you mentioned in Norway and India follow the same protocol as the US and China?

6. Do the trial centers in Norway, India, China, and the U.S have DTI available and do you plan on augmenting the imaging data that you have already compiled?

7. Have you considered giving lithium to any of the patients who have already completed their one-year follow-up, or increasing the length of time that patients are taking lithium?

8. What do you think is the fate of UCBMC in vivo in the long term? Do they remain undifferentiated, or get crowded out by endogenous cells, or something else?

Thanks again.

[#LHB#]

I have a question if Dr Wise trial does improve function to an extent an say a couple of years later mp Schwann Cell come around and is a little bit better at getting function back, will you be able to get both? My question in a nut shell is do diffrent stem cells clash? Would any combo ofcells keep you from getting the therapy? If you got therapy A you couldnt get therapy B.

[paolocipolla]

Originally Posted by dorsal fin

True what leif says.Why do you constantly attack and question dr Wise youngs' work paolo? I understand your frustration, I do too as I am C6 incomplete, but this isn't the right way to approach this problem. When I was in rehab centre last christmas there was courses about stem cell technology and sci research and dr Wise Young was mentioned alot. I think dr Wise Young is the one that can save us with the help of donations.

dorsal fin,

I just asked for clarifications and I have expressed just my personal opinions based on what I have learned so far.

I still belive a cure is very possible, keep in mind that there is not just prof. Wise Young working on it.

Paolo

[Barrington314mx]

Originally Posted by paolocipolla

dorsal fin,

I just asked for clarifications and I have expressed just my personal opinions based on what I have learned so far.

I still belive a cure is very possible, keep in mind that there is not just prof. Wise Young working on it.

Paolo

how much have you got out of these others that are "working on a cure"?
im very greatful for the amount of information Wise shares with us.

[dorsal fin]

Originally Posted by paolocipolla

dorsal fin,

I just asked for clarifications and I have expressed just my personal opinions based on what I have learned so far.

I still belive a cure is very possible, keep in mind that there is not just prof. Wise Young working on it.

Paolo

Thats true. A big problem with sci research is money. If more people with spinal cord injuries started donation funds and marketed to support and aware others on spinal cord injuries in their local area to give bigger research companies. That would make us one step closer to a final cure.

[paolocipolla]

Originally Posted by Barrington314mx

how much have you got out of these others that are "working on a cure"?
im very greatful for the amount of information Wise shares with us.

Barrington,

if you can you should attend W2W &/or the Neuroscienze 2012 to meet other scientists that are working to find a cure for SCI.

http://unite2fightparalysis.org/working2walk__1

http://www.sfn.org/AM2012/

I think Wise has done a great thing setting up CareCure and I am very greatful for his time and the info he shares with us too.
I just think that, sometimes, some info are questionable.

Paolo

[paolocipolla]

Originally Posted by dorsal fin

Thats true. A big problem with sci research is money. If more people with spinal cord injuries started donation funds and marketed to support and aware others on spinal cord injuries in their local area to give bigger research companies. That would make us one step closer to a final cure.

I use to think that too, but now I think that if you just put money in the current sistem most of the $ will be wasted.
It is difficult to know where is the best place to put money, but it is necessary to carefully evaluate all the options around before taking a decision.

Do you know Leif Arild Fjellheim?
He is the president of the Norwegian SCI org. (and use to be my friend ) you may want to team up with him to see what he is working on with the SCI Net Norway.

Paolo

[Wise Young]

Originally Posted by KofQ

Dr. Young, I have some more questions When you have time.

1. Is Dr. Zhu (or anyone else) doing a rehab-only control to contrast with the Intradural decompression studies?
• It is difficult for Dr. Zhu to do rehab-only controls because most patients want to have some treatment.

2. Are any of the patients in your acute/subacute trials getting intradural decompression?
• All our patients in the subacute trials have gotten intradural decompression. That is when we implant the cells. I am not sure how many patients in our chronic trial received intradural decompression. I suspect that most have not. That is because most of the patients that received intradural decompression are no longer ASIA A.

3. Will your published results of the China trials contain both chronic and acute data, and will they be presented discretely?
• The subacute and chronic trials will be presented separately. They are two different trials.

4. I believe that your U.S. trials have a rehabilitation only arm. Will the FDA (or anyone else) continue to mandate this in future trials? Repeatedly proving that rehab alone will not get a chronic ASIA A walking again seems a waste of resources.
• I can't predict the FDA. Much depends on whether the FDA considers the rehabilitation to be part of the combination therapy. If they think that it is a component of the combination therapy, we need to include a rehabiitation only component.

5. Will the trials you mentioned in Norway and India follow the same protocol as the US and China?
• The China trial is likely not to have a rehabilitation only or lithium only component. It is likely that the U.S. and Norway trial will likely have a rehabilitation only component. We don't know yet.

6. Do the trial centers in Norway, India, China, and the U.S have DTI available and do you plan on augmenting the imaging data that you have already compiled?
• DTI is unlikely to be available in China and India. Even though they have the machines, they don't have enough experience yet and the presence of metallic implants interferes with MRI/DTI. I don't know about Norway and the U.S. I suspect that many U.S. centers cannot do DTI.

7. Have you considered giving lithium to any of the patients who have already completed their one-year follow-up, or increasing the length of time that patients are taking lithium?
• We are considering but have not implemented. It will be another trial.

8. What do you think is the fate of UCBMC in vivo in the long term? Do they remain undifferentiated, or get crowded out by endogenous cells, or something else?
• In animal studies, at least for as long as we have looked in cyclosporin- treated rats, the cells do not become neurons or other cells. I know that other groups have reported that some umbilical cord blood cells become other cells but we have never seen it. On the other hand, I believe that UCBMC contain Muse cells, CD133+ cells, and other cells that are pluripotent. If these cells are isolated and then grow in media that stimulate them to become neurons and then are transplanted, they can replace neurons. This is what we are trying to do in the laboratory now, using minimal manipulation. We don't want to do genetic manipulation because that present significantly greater regulatory hurdles.

Wise.

[Leif]

Discussions and work to be able to do DTI on SCI in Norway is in process.

[Barrington314mx]

Originally Posted by Wise Young

2. Are any of the patients in your acute/subacute trials getting intradural decompression?
• All our patients in the subacute trials have gotten intradural decompression. That is when we implant the cells. I am not sure how many patients in our chronic trial received intradural decompression. I suspect that most have not. That is because most of the patients that received intradural decompression are no longer ASIA A.


Wise.

why would you NOT do the intradural decompression while ur already in there on chronics? couldnt that effect results negatively if the cord is still compressed?