ChinaSCINet Update

[lunasicc42]

Then you shouldn't say anything!

Jim,I assure you that this is NOT the way 99.9% of us feel ...keep saying what you can

[DOREEN]

Dr. Young or anyone, Is there anyyyyyyyyyyyyyyyyyy way we can get in the trial in China? What if I became a Chinese citizen? I know it was said that it wasn't an option but wondering if it could be reconsidered if I/we became citizens and stayed there for the time needed?

[Jim]

Doreen, it is not likely that you could be in the China trial, but let's say somehow you got in. Phase III is randomized and you could wind up in the least effective treatment group. When a treatment is discovered that significantly improves the lives of people there will be a major push to make it available to all as soon as possible.

[DOREEN]

Hi Jim, thank you. You've mentioned that the results so far are very impressive, would you consider that a treatment that significantly will improve our lives?

[JamesMcM]

Honesly F$$$ SCIs, and F$$$ my stupidly for doing this to myself, honestly Id choose death over living the rest of my life as a quad, no questions Frig i asked them to leave me in the field I was launched into, then asked them to let me die three times in the hospital, to no success. A lot of people are happy with SCI (as happy as they can be), some are not but the thought of returning to normal, or even a glimmer of normal brings emotions and desperation. Jim I'm sure you understand that, so these kinds of comments, speculation, doubts, repetitive questions are to be expected from all of us.

[Wise Young]

Dr. Young or anyone, Is there anyyyyyyyyyyyyyyyyyy way we can get in the trial in China? What if I became a Chinese citizen? I know it was said that it wasn't an option but wondering if it could be reconsidered if I/we became citizens and stayed there for the time needed?

Hi, Doreen. Where do you live that makes you want to go to China?

We are still deciding which centers will be participating. At the present, we are thinking that we will have six centers in mainland China. Three will be military: Beijing Army General Hospital, Third Military Medical University in Chongqing, and Fourth Medical University in Xi'an. Three will be academic: Peking University People's Hospital in Beijing, Tongji University Hospital in Shanghai, and Jiaotong University Second Affiliated Hospital in Xi'an. There will be three walking centers (Tongren Hospital in Kunming, China Rehabilitation Research Center in Beijing, Jiaotong University Second Affliliated Hospital in Xi'an). After receiving the cell transplants, patients will go to one of the three walking centers.

In Hong Kong, the Queen Mary Hospital of Hong Kong University and the Prince-of-Wales Hospital of the Chinese University of Hong Kong will be participating. We are working on getting walking centers established in MacLehose Rehabilitation Center next to Queen Mary Hospital and the Shatin Hospital next to the Prince-of-Wales Hospital. In Taiwan, the China Medical University in Taichong will be one of the sites. A walking center is being established in one of the China Medical University hospitals in Taichong.

In China, none of the military hospitals will take foreign patients but the three civilian hospital might take students from overseas. However, English is very limited in the hospitals and patients must move from the hospital where they get transplants to the walking centers. I don't know for sure yet but I think that the Hong Kong centers will be able to take overseas patients... much depends on how much money and from what source we get the money. I have not yet talked to our investigators in Taiwan about this.

We will be conducting the trial in the United States, Norway, and India. Each of the countries will be studying 40-50 subjects. In the U.S., the centers will all be located close to New Jersey. After surgery, the patients will undergo outpatient rehabilitation to learn how to do overground stepping for 6 weeks. Then they will train for 3-6 months at a walking center, at Push-to-Walk in Northern New Jersey or at Long Island Jewish Hospital.

A lot of these things are still being organized. We are unlikely to get regulatory approval for the trials before the end of 2014. I hope that we will be able to start the charts in the second quarter of 2015. Much of my effort of the past six months has been devoted to transferring technology for cell processing to China and applying for funding from various sources in Hong Kong and China, helping Stemcyte do their IPO (initial public offering) which will help for the trials. I estimate the cost of the trials to be close to $20 million U.S. in 2015-2016.

As soon as recruitment and treatment phase of the phase III trials are over in the United States and Europe, we will apply for compassionate use approval of the treatment, so that people don't have to wait for the completion of the phase III trials before having access to the therapy. I expect that there will be significant demand for the therapy if the trial turns out to be positive and therefore have been working with Stemcyte to establish an 3,000,000 (from 30,000 cord blood units) umbilical cord mononuclear cell library for this purpose by 2016.

Our proposed clinical trial will randomize subjects to surgery without transplants or lithium, surgery with 6-week course of lithium, surgery with UCBMC transplants, and surgery with UCBMC transplants and 6-week course of lithium. All subjects will then receive a 3-6 month locomotor training.

Wise.

[Sue Pendleton]

LOL yall some rude ass ppl

Rude works in some places. This isn't one of them. I love your comments Cable Guy!

[Jim]

Doreen, that will be up to you to decide after you review the data.

[taymas]

Hey Mr Wise Young, thanks for the update - I have a question regarding this therapy which I'm sure may interest a lot of SCI'd folk.

Would this therapy (once approved) be available to those who've developed syringomyelia as a result of a traumatic SCI?

For example, I have developed a syrinx from T5 (site of injury, ASIA A) to around C2, ~7mm diameter at the thickest point. (Mine is likely to get worse, but have minimal loss as a result)

So I'd imagine the cyst would be drained by means of a shunt or otherwise, then the therapy would follow?

We appreciate your work and those involved... Keep us updated,

Regards

[DOREEN]

Hello Dr. Young,

Thank you. I live in Connecticut, about 30 minutes from NY border. Just anxious to do something before my mother's dementia gets worse, she devoted her life to me to see this day.

[kimg]

Dr.Young,
whereabouts in Norway will the phase 111 trials be, I live in UK so Norway is near to me and I would like to participate in the trials there.

[void]

Dr.Young,
whereabouts in Norway will the phase 111 trials be, I live in UK so Norway is near to me and I would like to participate in the trials there.

Since the trial is to large extent paid by the norwegian government I don't think you can participate.

[JamesMcM]

Ah that's a good question, low and behold I have one of thous wonderful cysts as well frig...

[PC720]

Hey Mr Wise Young, thanks for the update - I have a question regarding this therapy which I'm sure may interest a lot of SCI'd folk.

Would this therapy (once approved) be available to those who've developed syringomyelia as a result of a traumatic SCI?

For example, I have developed a syrinx from T5 (site of injury, ASIA A) to around C2, ~7mm diameter at the thickest point. (Mine is likely to get worse, but have minimal loss as a result)

So I'd imagine the cyst would be drained by means of a shunt or otherwise, then the therapy would follow?

We appreciate your work and those involved... Keep us updated,

Regards

I found this the other day. You might find some information in here of course you will have to scroll down to see Dr Wise' answer

[ineedmyelin]

Hi, Doreen. Where do you live that makes you want to go to China?

We are still deciding which centers will be participating. At the present, we are thinking that we will have six centers in mainland China. Three will be military: Beijing Army General Hospital, Third Military Medical University in Chongqing, and Fourth Medical University in Xi'an. Three will be academic: Peking University People's Hospital in Beijing, Tongji University Hospital in Shanghai, and Jiaotong University Second Affiliated Hospital in Xi'an. There will be three walking centers (Tongren Hospital in Kunming, China Rehabilitation Research Center in Beijing, Jiaotong University Second Affliliated Hospital in Xi'an). After receiving the cell transplants, patients will go to one of the three walking centers.

Wise.

Darn, sounds like Brackenridge in Austin, Tx is no longer a trial site.