ChinaSCINet Update

[pavitrak]

What is the update? And future trial plans.

Johnnie, once the therapies have been shown to be safe and beneficial, they should be available everywhere around the world. As you know, we are planning to do trials in the United States, India, and Europe as well. So, it should spread quite quickly. I am of sure that there will be private hospitals in China offering the therapy as well.

Regarding the timing, I am not sure. In the United States, if the results are convincingly positive and the treatments are safe, the FDA has a category of approval called compassionate use (for conditions where there is no other therapy and I think that spinal cord injury would qualify) where approval could be given in a year. In China, it may take longer.

On the other hand, I expect that there will be many purveyors of umbilical cord blood cell therapies in places like India, Caribbean, Mexico, and China. Many people think that they can isolate umbilical cord blood mononuclear cells and lithium is easy to give. In fact, there are doctors now offering bone marrow cells and lithium in these places, but most clinics are giving the cells intrathecally, which I don't think is the best way.

If it were my body, I would want to best and reliable source of cells. The problem with all these non-accredited sources is you have no way of knowing how good their cells are. Be very careful. They will claim to you that they have GMP (Good Manufacturing Practice) laboratories and so on. Make sure that the cells are well-vetted before allowing them to inject cells into your body.

Most of third world medical tourism clinics don't have access to large libraries of high quality umbilical cord blood for HLA-matching. So, they often use non-HLA-matched cells. Most don't know how to isolate mononuclear cells from frozen cord blood units (it is quite difficult). Most of them cannot guarantee even the sterility of the cells.

We are working with the best company that we can find to provide us with HLA-matched cells under the highest accreditation standards. If the trial shows that the therapy works, the company can ship HLA-matched cells to anywhere in the world as soon as the therapy is approved. Other companies will be able to do so as well, in time.

So, if our phase 3 trial starts in 2011 and shows that the combination UCBMC+lithium therapy is safe and restores function by 2012, I think that the therapy will be approved in the U.S. and China by 2013. But, please be aware that there are many potential causes of delay. We cannot be too careful in terms of safety and making sure that everything is done right.

It is also possible that the therapy will not do as much as we hope. In that case, we go on to other therapies. I know that it is hard to wait and very frustrating but I am heartened that many others trials are starting. Our goal is to get as many trials going as possible. Sooner or later one or more therapies will work. That is when the world will begin seriously investing in the cure.

Wise.

Dr Young,

Great work! What is the status on the China trials now? And when can we expect to hear about the results? I am based in India and am very interested in hearing more about your plans for clinical trials here. Have you decided on a place? And timeframe? Will this start after results are obtained on the tests in China (end 2012...?)

[keeping on]

lunasicc, 2011 will be a good year, but Wise's chronicle of what to expect seems like at best 2013 will be year of action. I would hope that I'm wrong, but hopeing doesn't get us anywhere. 2013 isw a long way off.

keeping on

[keeping on]

I'm convinced as many others on this board are that treatments are coming. It's going to take several years to happen. i've said before and and am saying again; many of us are transtional figures in this mess. We know that things are coming but my fear is that it won't be in time for many of us. Just the way things are panning out.

keeping on

[Jawaid]

For the results of Wise's trials we must wait for 6 months as told by Dr Wise himself. After 6 months Wise will be able to tell how treatment works.

So wait and see. Only coming time can decide something for us. I know it is very very hard to wait but we have to. We have to keep close eye over the trials of Embryonic and Neural cells along with regenerative therapies.

God bless you all my friends.

[keeping on]

jawaid, you are correct in thqat Wise at some time will let us know of the success or not of his trial. Hopefully in six months; maybe; but 2013 is what he projected. We hopefully will see things moving quicker adn other trials will accellerate as Wise indicates he wants. Whether a miracle happens is up for question. Wiating is difficult for us , but time lag between assertion of trials is another. All we can do is acutely being obsevant adn critcal of announcements and trials. I still hope that 2011 is q golden year for real research and therpies that work.

keeping on

[0xSquidy]

All we can do is acutely being obsevant adn critcal of announcements and trials

I'm sorry keeping on, but when you say bs like that you are disappointing and misleading.

[keeping on]

Ox, it's important to keep things on track. No bs just facts,

keeping on

[christo231]

Some of you guys just need to chill! We're all in the same boat here and we should all be happy that these trials are going on right now! Most of us know that it is important to stay engaged, in the whole process. From giving donations, to getting the word out that donations are needed! There's no need to get pissed at one another for talking about having hope or anything like that! The process has begun! All we can do is get the word out, raise some money, and trust in those who are doing this extremely important work to try to help us!

[keeping on]

Guys, Wise must be in Hong Kong doing additional patients. We should get some info by June from Geron and Wise on these first 2 trials. 2011 is going to be a good year for research.

keeping on

[KIM]

Guys, Wise must be in Hong Kong doing additional patients. We should get some info by June from Geron and Wise on these first 2 trials. 2011 is going to be a good year for research.

keeping on

If results are positive.

[keeping on]

yep!!

keeping on

[Jawaid]

If results are positive we will not believe it because of our happiness.

Plz come soon that day.

[Papa joe]

Would it be possible for one of the participents in Wise's trial to Blog on this forum?

[keeping on]

papa joe, good idea, but I think wise will hold that close to his vest. I'm assuming, only assuming, that Wise is going full tilt on his trials. By May or June , we should get an update on how things are going. Let's hope and pray that things turn out positively for all of us.

keeping on

[0xSquidy]

Papa Joe, IMO i don't think it's a good idea to have patients from the trial giving us their subjective opinions.

Let's try to be patient.

Are you doing something supportive in the meantime?