ChinaSCINet Update

[paolocipolla]

Paolo,

We have proposed a series of studies that would lead to clinical trials of the combination of UCBMC, lithium, and Cethrin, if the experiments work. Why are you so opposed to planning for clinical trials so that the preclinical results go directly to trial if they are successful?

You seem to be convinced that Cethrin does not work even though you have no data to suggest that it does not work. No data does not mean that it will not work. It simply means no data. We will get this data. If the animal experiments don't show any benefit, we go to another therapy.

If our results support safety and efficacy of the combination treatment, we plan to move ahead quickly without having to wait a year or two for the fundraising and submitting for regulatory approval. Planning ahead eliminates delays.

To use your analogy of running in the New York marathon, we both agree that we won't be running in the marathon in 2014 if we don't prepare seriously for the marathon. If we fail, you can say "I told you that you can't do it" but please don't start saying that we will fail before we even start.

Finally, regarding why nobody has studied Cethrin in chronic animal spinal cord injury, have you considered the possibility that funding for chronic spinal cord injury studies is limited because there are nihilists saying that no therapy will work on chronic spinal cord injury?

Wise.

Wise,

I am afraid that you missed the last part of my post where I say:

"In any case I would like to see serious studies done with cethrin on animals with chronic SCI ASAP and if there will be indications of efficacy I would like to see Cethrin in clinical trials for chronic SCI ASAP."

Then I agree with you that one of the reasons why funding for chronic spinal cord injury studies is limited is because there are nihilists saying that no therapy will work on chronic spinal cord injury.
In fact, as you know, I have requested SCI orgs to restrict founding to research project focusing on chronic SCI and I keep bringing up this issue when I can as I believe it if very unethical for SCI orgs to take donations from people with chronic SCI and spend the money for acute SCI which is what is still happening most of the times with all the SCI orgs and I wonder why so few SCI advocated have taken action to fix this non sense.

Paolo

[Leif]

If not for Wise – I think none of us (or any) would know anything about SCI fixing stuff (science), let alone SCI issues when it comes to daily living issues (care etc,). - I happen to live in one of the best countries when it comes to SCI-care, a very good and a great place with SCI-units etc. - I also happen to know a fellow in 2005, at CC, namely dr. Young. Thereafter, (short story long) I too was in an opposition, like a kid on the block not knowing anything, about anything. - But dr. Young has overwhelmed me by so much what he has contributed here on CC and otherwise – I’m an engineer and have been around in my life, please do not misunderstand me – that I am in total awe of what that man (a person) does. - I thought that I was clever, had stamina - on anything I was doing, projects etc. and didn’t give up (before SCI and after) and took all problems as challenges. But very honestly, - I have met a man, whom does much better, much better, than any, and he does not even have a spinal cord injury.
- I have not said this before, -and I’ve been around in life – but never ever have I met a so dedicated person like dr. Wise Young. A super dedicated doctor, not dedicated solely on SCI cures, - but a doctor that knows more than any about anything when it comes to spinal cord injuries. Anything. And any should be proud to have dr. Young, for example as a guide on Ph.D.’s (I don’t, sail in that league), or anything when it comes to medical classes - I personally have not seen such a knowledgeable person in my life. And such a good person in my life. Never. This though doesn’t mean that I am a true believer of any or anything. I am a person too - I have read books up and down and I am working with the best and a lot of good things. I am not a” blind follower “etc. etc., But if not for Dr. Wise Young, I would have known little nor anything, to question any or to do what I like to do. - I am a hard nail, but I tell, only this time - folks - thank you Dr Wise Young for you’re efforts. You are a great person. And if I can help you sometime in you’re life, count on me. I am honored to be a friend of you Wise. Nuff said! Leif Arild

[Jim]

I removed a lot of back-and-forth bs.

For those of you who continue to attack others, don't be surprised when your posting privileges are revoked.

[ineedmyelin]

I removed a lot of back-and-forth bs.

For those of you who continue to attack others, don't be surprised when your posting privileges are revoked.

Just a suggestion, why not create a "Rants & Raves" forum? Its getting annoying to have to wade through so much useless hot air just to get to something useful and meaningful.

[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.

[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]

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]

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]

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]

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]

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]

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]

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?