ChinaSCINet Update

[Han Solo]

I feel that but Im just tired of updates, I need to hear it's time to fix us now

[tumbleweeds]

After much discussion and some work, we have decided to go ahead to do phase II trials in U.S./Norway, India, and China. India changed its regulations so that a new organization called Drug Controller General of India (DCGI) will be approving clinical trials. They have given stem cell therapies a high priority and are willing to provide conditional market approval after phase II trials. China published new regulations in April that placed very stringent (tough) requirements for approval of stem cell therapies. Furthermore, it requires a Chinese company to be the sponsor of the trials. So, Stemcyte (the U.S. company donating cells for the trial) has been looking for partners. In the meantime, we are planning to go ahead with phase II trials in China, India, and the U.S.A. These trials have three goals. First, we want to show that intensive 6 hours/day, 6 days/week, and 3-6 month locomotor training is possible outside of Kunming. Second, we want have stronger evidence that lithium may be beneficial when given alongside

In the meantime, we are being helped by PPD, a clinical research organization, paid by Stemcyte. This spring, we trained three universities to process the umbilical cord blood to obtain mononuclear cells for transplantation: Jinan University in Guangzhou, Tongji university in Shanghai, and Xi'an Jiaotong University. We talked to a fourth center in Dahlian last week and will be trying to bring them on board. We are hoping to get provincial approval of the cell processing facilities and apply to the government for permission to do the trial.

Wise.

Is the U.S trial to be just at the New Jersey center or are there others planned?

The major question that we are debating now is whether ASIA B and C should be included in the phase IIb. I believe that people who are stable ASIA B and C chronic SCI do not recover very much without therapy and therefore should be candidates for the trial. However, some of the investigators believe (legitimately in my opinion) that the trial would be much more credible if all the subjects were complete, i.e. ASIA A, like it was in our trials to date. Unfortunately, we are finding that relatively few people with chronic SCI are ASIA A.

Wise.

And has a decision been made on whether ASIA B or C can participate in phase IIb?

[Jim]

The last I heard there will be 18 ASIA A subjects at one center.

[tumbleweeds]

Thanks Jim.

[Eric.S]

After 16 years and my mother now being in the hospital im honestly starting to feel like theres no hope... sorry to turn this into a downer post but sometimes you just get tired.....

[ineedmyelin]

After 16 years and my mother now being in the hospital im honestly starting to feel like theres no hope... sorry to turn this into a downer post but sometimes you just get tired.....

25 yrs post here, mom turns 70 in feb. and is still doing the heavy lifting...........that kills me. was injured a month after turning 20 and thought that i was young enough that science would produce a something before i turned 25, lol. turned 25 and nothing but still thought that by 30, 35, 40, 45 but nothing has happened. i'll turn 46 in nov and feel like i'm down to my last drop of hope. the worst is late at night the thoughts of hopelessness and despair. oh well maybe something will happen before i reach 50.

[Eric.S]

25 yrs post here, mom turns 70 in feb. and is still doing the heavy lifting...........that kills me. was injured a month after turning 20 and thought that i was young enough that science would produce a something before i turned 25, lol. turned 25 and nothing but still thought that by 30, 35, 40, 45 but nothing has happened. i'll turn 46 in nov and feel like i'm down to my last drop of hope. the worst is late at night the thoughts of hopelessness and despair. oh well maybe something will happen before i reach 50.

It's like we have the same life with the same thoughts. Mine just ten years later. Excuse my language but it's fucked up....

[lunasicc42]

Sooooooo...whats going on here?

[MeetMeInMontauk]

Is there anymore news on Wise and Team Fight2walk metting with Congress in July about clinical trials in the U.S.?

[PC720]

25 yrs post here, mom turns 70 in feb. and is still doing the heavy lifting...........that kills me. was injured a month after turning 20 and thought that i was young enough that science would produce a something before i turned 25, lol. turned 25 and nothing but still thought that by 30, 35, 40, 45 but nothing has happened. i'll turn 46 in nov and feel like i'm down to my last drop of hope. the worst is late at night the thoughts of hopelessness and despair. oh well maybe something will happen before i reach 50.

Don't lose that hope. I think the biggest difference between you at 35 and you now is the fact there are positive results in trials now. Trials that did not even exist 10 years ago. My biggest positive note is the guy from Poland seeing his before and after MRI. That blew me away.

[neerajbans@gmail.com]

Dr. Young,

My sister is Chronic complete ASIA A and in India. Please let me know whom to reach out, in case she can apply for the trial and if there is a place available.

Regards,
Neeraj Bansal

[Jim]

Najeer,

Send me the email address you want me to add to our eBulletins list. This is the way we will disseminate info about all upcoming trials.

jimbenn@rutgers.edu

[tompocket]

Hi, does anyone know if Wise's paper has been published?

[Jim]

It has not yet.

[tompocket]

It has not yet.

Any idea when it will? Do you know why there has been a hold up?