Dr Wise Young speaks about Spinal Injury & Cord Blood

[Scaper1]

Thank you Wise. I really wish these trials were getting more attention. Not only because it would no doubt stimulate the necessary funding, but also because you're already doing what most North American sci foundations ingenuously claim is years away.

If I may ask, who else is involved in the consensus conferences?

[Buck503]

Originally Posted by Scaper1

you're already doing what most North American sci foundations ingenuously claim is years away.

This drives me nuts, too. More often than not, at the end of
an article about a supposed breakthrough, the scientists claim
that human applications are still years away.

I try not to sound like I don't appreciate all the research, but
sometimes it seems like for scientists, success in their labs is
is enough of an achievement.

[Scaper1]

Oops, that should have read "disingenuously". It's hard to believe that they're totally unaware of the China SCINet trials, which is why I'm wondering if anyone from the US or Canada has even come to observe one of the surgeries?

[pcoollll]

How patiens(all) are the trials in Hong Kong and Kunming,WISE?

[Barrington314mx]

Originally Posted by Wise Young

The trials in Hong Kong have already indicated that the surgery can be safely carried out to expose the spinal cord and that 4- and 8-µliter injections of umbilical cord blood mononuclear cells can be safely made into the spinal and lithium can be safely given to people with chronic spinal cord injury. Although phase 2 trials are not powered (have sufficient patient numbers) to show small improvements of neurological function), if it causes large improvements in function, we should be able to see it in these trials.

We will be applying to the U.S. trial this fall, as soon as the safety data from the transplants become available from the trials in Hong Kong and Kunming. The trials in the United States, while not identical to the UCBMC trials done in China, will be testing the same therapies. So, if the therapies are not safe in China or we don't see a trend for improvement, we may go to another therapy in 2012. That is one of the reasons why we are holding consensus conferences on the best therapies to test next.

Wise.

very nice. sorry if my questions are repeats. i have only been injured since last october, and just found this forum. i did find the hong kong trial a couple months ago, and emailed them about enrollement. they said you have to be a hong kong resident, but would put me on an email list for the US trial. my next question is, can anyone (within the criteria of course) apply, or is it invite only? thank you Wise.

[Fly_Pelican_Fly]

Wise, who actually controls SCINetChina and the therapies chosen? Is there any danger that the Chinese decision makers will ONLY want to test therapies that are being produced by domestic Chinese scientists - of which there are many of course.

Also, why cant SCINetChina run therapies in parallel? Why cant these be planned 'yesterday'? I would have expected at least 3 of 4 other therapies were already being lined up before you started the Hong Kong trial.

Finally, SCINetUSA centres will no doubt overlap with NACTN centres - will there be any political conflict here?

[lunasicc42]

wise, you stated that you are already holding consensus on which therapies to try "next"... Why? Did this Treatment prove itself to not be beneficial enough?

[Isildur]

Originally Posted by lunasicc42

wise, you stated that you are already holding consensus on which therapies to try "next"... Why? Did this Treatment prove itself to not be beneficial enough?

I think is simply a way to save time in case the treatment doesn´t work like they thought. When you start a project like that, you need to have a backup plan, even when the fail risk is minimun.

[Christopher Paddon]

And some injuries won't be as well treated with cord blood and lithium as others, eg lower back and neck injuries where vital neurons have died. So even if the cord blood and lithium is a great success other treatments are needed.

[Wise Young]

Fly_Pelican_Fly,

I guess the leadership of SCINetChina influences the choices but the decision is made by the investigators. All decisions are made by consensus and can only be acted upon if and when the investigators agree. They may decide to favor treatments that are discovered by Chinese scientists. That is their prerogative, in the same way that a SCINetUK or SCINetUSA may choose British or American-discovered therapies.

The reason why we can't test therapies in parallel is the lack of funding. We are raising all the funds in Hong Kong and we do not have the staff or the funds to conduct multiple parallel trials. I hope that we can do this someday, however.

"Lining up" therapies is not the same as having them ready for trial. It is an incredible amount of work getting regulatory approval for taking therapies to trial. This includes writing up fully vetted protocols, getting agreement on the protocols by the investigators, collecting all the data together to support the protocol, negotiating the clinical trial contracts with all the participating centers, making sure that the treatment is ready to be used in humans, and getting regulatory approval for the trials. Please, this is typically work that is done by huge regulatory departments with dozens or even hundreds of professional staff. We are doing this with a 3 paid staff and several volunteers (like me).

There is currently no overlap with NACTN and SCINetUSA centers. Even if there were, I don't think that there should be or would be conflict. Many centers do multiple clinical trials. At least right now, we are testing therapies on two very different populations of patients. SCINetUSA is focussing on chronic spinal cord injury and NACTN on acute spinal cord injury. I don't see a conflict. By the way, I strongly encourage others to develop and organize clinical trials.

I have long been a supporter of the Christopher and Dana Reeve Paralysis Foundation and have donated to them before, during, and after Christopher Reeve. In my opinion, they are trying very hard to do the right thing. They, like everybody else, currently do not have the money to do everything that they want to do.

Wise.

Originally Posted by Fly_Pelican_Fly

Wise, who actually controls SCINetChina and the therapies chosen? Is there any danger that the Chinese decision makers will ONLY want to test therapies that are being produced by domestic Chinese scientists - of which there are many of course.

Also, why cant SCINetChina run therapies in parallel? Why cant these be planned 'yesterday'? I would have expected at least 3 of 4 other therapies were already being lined up before you started the Hong Kong trial.

Finally, SCINetUSA centres will no doubt overlap with NACTN centres - will there be any political conflict here?