ChinaSCINet Update

[Wise Young]

Who are currently performing these functions?

I have a staff of 4 people in Hong Kong. They are supported by the Hong Kong Spinal Cord Injury Fund. They do all the regulatory work, clinical trial monitoring, planning, and fundraising for ChinaSCINet. I fly there every 3 weeks.

Wise.

[Wise Young]

Wise,

here above is an example of how people can get confused hearing/reading what you say.
You can always say that people misunderstand, but that is not how the "communication process" works.

Paolo

Paolo,

Are you dissatisfied with my communication skills or suggesting that I am misleading people? There is a difference.

Regarding your comments in blue, may I suggest that you raise some funds for clinical trials in Italy before you criticize how ChinaSCINet has been conducted. If there is anything that you don't understand, I would be more than glad to answer your questions as best as I can but I cannot take any of your comments seriously until you show that you understand what it takes to raise the funds for and to do clinical trials. By the way, if you think that I am being unfair to you by asking you to do this, please look what Christopher Reeve did from 1996-2004. He raised over $100 million for spinal cord injury research during this period. Christopher was not so different from you. In fact, he was actually much worse off than you because he was much more severely injured and had no means of supporting his care and family.

Wise.

[Wise Young]

Wise will you be starting phase3 trials in India or phase2? Are u thinking to include lower lumbar injuries in india trial or not yet?

Can foreign patients join trials in india or norway?

Researchers at Silk Institute have produced neurons from Umbilical cells recently. Hope you read at carecure. If so umbilical cells can be tested in lower injuries too.

The trials are being planned for mid-2013. Much depends on our success in getting agreements with the participating organizations and also fundraising. I was in India in June and will be in India again in September.

Wise.

[Wise Young]

Jawaid theres no stemcell trials in Norway for all I know. One year ago I damaged my spinal cord and was at the biggest rehab centre for sci patients in scandinavia here in Norway. No one talked about coming stem cells trials, although my neighbour patient got injected with stem cells at stem cells inc and participated in their trials.

dorsal fin, I am hoping to get trials started in Norway in 2013. There are none currently going on. Wise.

[Wise Young]

Hi Dr Young
Is it possible to get a list of the exercises regime that was done in the china trial. I would like to do at home. I already do quite a bit of pt at home including treadmill, recumbent bike, leg press, leg raises etc. I walk now full time with crutches and progress has been continuous but slow. I'd like to see if there is more I can be doing to speed my recovery.

Thanks

James

James,

The exercise is simple. It is just walking with a rolling support cart for 6 hours a day 6 days a week. They start by standing and progress to stepping with somebody walking behind with ropes to lock the knees during stance phase. Eventually, the person is able to lick their knees by themselves. At some point, the person can use a four point walker, then crutches, and then crane.

They do have exercises for the hands and arms but I don't think that these are as systematic. Every morning, all the patients go through about an hours of calisthenics, with music and a nurse standing in front of all the patients leading the calisthenics.

Dr. Zhu has now moved from the Kunming Army General Hospital to a separate private hospital in Kunming where she will be much better staffed and equipped. In addition, she will be able to take foreign patients for the first time. She just moved and does not yet have the staff to handle a large volume of enquiries. I will post as soon as I know that she is ready to do so.

Wise.

[rjg]

James,

The exercise is simple. It is just walking with a rolling support cart for 6 hours a day 6 days a week. They start by standing and progress to stepping with somebody walking behind with ropes to lock the knees during stance phase. Eventually, the person is able to lick their knees by themselves. At some point, the person can use a four point walker, then crutches, and then crane.

They do have exercises for the hands and arms but I don't think that these are as systematic. Every morning, all the patients go through about an hours of calisthenics, with music and a nurse standing in front of all the patients leading the calisthenics.

Dr. Zhu has now moved from the Kunming Army General Hospital to a separate private hospital in Kunming where she will be much better staffed and equipped. In addition, she will be able to take foreign patients for the first time. She just moved and does not yet have the staff to handle a large volume of enquiries. I will post as soon as I know that she is ready to do so.

Wise.

Dr. Young,

I am a c6-7 sensory incomplete, but I can lick my knees by myself. Does that mean I'll be eligible for the U.S. trial?

[Wise Young]

Dr. Young,

I am a c6-7 sensory incomplete, but I can lick my knees by myself. Does that mean I'll be eligible for the U.S. trial?

rjg,

We have not yet decided the inclusion criterion for the Phase III trial in the U.S. So far, we have been requiring that all subjects for the Phase II trials in China be ASIA A (complete) spinal cord injury. We are considering including ASIA A, B, and C for the ChinaSCINet Phase III trial (CN103). However, in the U.S., because we don't have enough money for all the patients, we may have to restrict it to ASIA A subjects.

At the Thursday Open House, I indicated that we are seriously thinking of planning clinical trials aimed at people with incomplete spinal cord injury in the future. I have long felt that incomplete patients have been neglected in clinical trials and that most clinical trials have focused on complete injuries. There are many treatments for incomplete spinal cord injury.

Wise.

[Barrington314mx]

James,

The exercise is simple. It is just walking with a rolling support cart for 6 hours a day 6 days a week. They start by standing and progress to stepping with somebody walking behind with ropes to lock the knees during stance phase. Eventually, the person is able to lick their knees by themselves. At some point, the person can use a four point walker, then crutches, and then crane.


Wise.

is that an observation or the expected results? the reason i ask is 1. because im just plain curious. and 2. because you said "the person CAN". so it leaves me speculating. sorry.

[peterf]

I too am very interested in this exercise
At what type of injury and ASIA score can this be achieved.
Is there any internet video we can see?
Tks

[mgwmgw]

Cannot include all patients....

There is not enough money to include all kinds of patients.
So...what approximate amounts of money would be required
to include the optimal kinds of patients?

Is there any possibility of petitions
or asking christopherreeve.org or
hhmi.org
or the Department of Defense and initially concentrate on veterans
http://www.grants.gov/search/search....W&oppId=173498
or somehow else to get enough money?

[Wise Young]

is that an observation or the expected results? the reason i ask is 1. because im just plain curious. and 2. because you said "the person CAN". so it leaves me speculating. sorry.

Barrington314mx,

What I said is neither an observation nor an expected result. I was asked what kind of exercise they do in Kunming. I simply described the walking exercise and did not say what the patients are, what they were treated by, or what expectations are.

May I request that you ask your question rather than speculate about what I did not say? Presumably, what you want to know is the extent to which people with ASIA A injuries recover walking as a result of the intensive training that they do in Kunming without treatment. I don't know the answer to your question because almost all their patients have been treated in one way or another.

Dr. Zhu and her colleagues have published a surgical procedure that they apply during 1-4 weeks that follow spinal cord injury, called intradural decompression to people with ASIA A complete spinal cord injury. Many of the patients recovered walking in that study. That was where the "can" comes from. Yes, some ASIA A patients did recover Kunming Locomotor Scores of X or better after have had the surgery and the intensive locomotor training. They did not do concurrent controls and therefore we do not know how many people would recover such walking from the locomotor training alone.

It is my impression from their surprise and excitement over seeing patients with ASIA A spinal cord injury walk so well that they normally do not expect to see such good walking recovery without the surgery. That is one of the reasons why they feel strongly that patients should receive the intradural decompression shortly after injury. But, they simply have not collected data concerning how many acute or chronic ASIA A patients would recover from the locomotor training alone.

Does that answer your question?

Wise.

[KofQ]

Dr Young,

I have a few questions when you get a minute.

1. Have there been any additional adverse events since you last reported them in April?

2. You mentioned having to find a Chinese principal investigator as well as a Chinese entity to process the cells. Who are doing these things now?

3. You mentioned using Cethrin in a planned Phase 2 trial in NJ. Do you plan on administering the Cethrin on top of the dura as was done in previous trials?

4. Do you think that the planned phase 2 trials in NJ and/or TX will impact the start date for the phase 3 trials?

Thanks very much for all your hard work and best of luck with the trials.

[Wise Young]

There is not enough money to include all kinds of patients.
So...what approximate amounts of money would be required
to include the optimal kinds of patients?

Is there any possibility of petitions
or asking christopherreeve.org or
hhmi.org
or the Department of Defense and initially concentrate on veterans
http://www.grants.gov/search/search....W&oppId=173498
or somehow else to get enough money?

The costs of the transplantation (surgery and 3 days hospitalization) and rehabilitation (6 weeks outpatient) in the United States would be about US$120,000 per subject, excluding the cost of the cell therapy (which is being donated).

The optimal kinds of subjects for proof of concept are people with chronic ASIA A injuries (which is what we are studying).

The Christopher Reeve Foundation is carrying out its own clinical trial: riluzole on acute spinal cord injury.

I have applied to DOD several times.

Wise.

[Wise Young]

My answers are embedded.

Dr Young,

I have a few questions when you get a minute.

1. Have there been any additional adverse events since you last reported them in April?
[No.

2. You mentioned having to find a Chinese principal investigator as well as a Chinese entity to process the cells. Who are doing these things now?
The cells are currently being processed in San Diego and then shipped to China. The doctors in the hospitals are the principal investigators for our current trials. We are currently scrambling to set up a processing center and to identify a Chinese principal investigator that all the other investigators will accept. We can't apply for an IND with the Chinese Ministry of Health until we have done both.

3. You mentioned using Cethrin in a planned Phase 2 trial in NJ. Do you plan on administering the Cethrin on top of the dura as was done in previous trials?
Yes, we are planning to put the Cethrin with fibrin on the dura. That was what was shown to be safe and to produce some recovery in patients in a phase I/II trial. Note that all three therapies (UCMBC, lithium, and Cethrin) have undergone phase I and II trials and shown to be safe.

4. Do you think that the planned phase 2 trials in NJ and/or TX will impact the start date for the phase 3 trials?
I hope not. By the time these phase II trials have finished their recruitment and treatment phase, CN103, US103, and NO103, and IN103 trials should be ready to go. The 2013 phase 3 trial does not depend on either of these two phase II trials. The results of the phase II trials should be available in time for the 2014 trials.

Thanks very much for all your hard work and best of luck with the trials.
You are very welcome.

[Barrington314mx]

Barrington314mx,


Does that answer your question?

Wise.

yes, that clears it up for me. thank you.