Wise: what's up with China?

[-scott-]

from the fact or fiction thread:

...we are in fact trying to jumpstart a clinical trial network in China to test combination cell transplant and growth factor therapies in large numbers of patients...[sic]...I of course have ideas about which therapies should be tried but the decision of what to try in such a trial should be a consensus decision made by the best scientists and clinicians in the field. I think, however, that there will not be any dearth of therapies to try...[sic]...We are hoping to start the clinical trial network in China in less than a year from now.

Wise, could you provide more details on this network in China? I understand that you won't be the decision maker on the therapies to try, but what are they likely to focus on the most? Why? What kind of timeline are they looking at? When are you going over there? If this proves successful, are you hoping/planning to model it in the states? Or, is there the option of creating (parallel?) networks in the aforementioned areas of N. America & Europe? Is widespread collaboration within a network of these sorts realistic to expect?

Hope you don't mind my inquisitiveness. [img]/forum/images/smilies/wink.gif[/img]

thanks,
~ scott

p.s. Susan is dead serious about the $$$. Please don't take that too lightly.

[Wise Young]

Scott, it is happening. The Ministry of Health of China has indicated their support of a China SCI Network that will test cell-based therapies of spinal cord injury. Several centers have been identified and we are trying to get a meeting together this coming September. We are also planning some fundraising activities to support the clinical trial network, an scientific exchange program where we hope to train people to do spinal cord injury research in China, and an international symposium next summer (2005) that would showcase the best work from China relating to cell-based therapies and spinal cord injury.

The China SCI Network would be very interested in collaborating with the North American SCI Clinical Trial Network and a related European SCI Clinical Trial Network that is forming. The Christopher Reeve Paralysis Foundation is helping organize the latter two. The exact form of collaboration is still unclear right now because all the networks are still fledgling and have not yet met to talk. We are hoping that the symposium next summer in Hong Kong will provide that opportunity to get all three networks together.

There is the possibility of an Asia SCI network that is growing. For example, I know doctors in Korea, Japan, Taiwan, Singapore-Malaysia, Thailand, Indonesia, Australia-New Zealand, and India... All these places have substantial numbers of spinal cord injury patients as well as doctors who are interested in clinical trials.

It will take time to get all these activities going, literally having to get hundreds of people to meet and learn from each other, and developing consensus concerning therapies, outcome measures, standards of care. Resources have to be established for sources of transplantable cells. Companies have to be involved to provide possible therapy candidates. And, above all, money has to raised to support these activities.

We have some major obstacles to overcome in China:

1. There is little or no history and therefore experience with randomized clinical trials in China. Patients will not be willing to enter clinical trials where they might be randomized to placebo. Therefore, we are initially considering a comparison of fetal OEG and fetal neural stem cell transplants.

2. Clinical centers in China have little or no provision for following patients once they have left the hospital. This is the main reason why Dr. Huang has been having so much trouble getting followup neurological examinations on his patients. Once the patients leave, they are gone. So, we have to develop a system and incentives for bringing the patients back or going to the patients. The latter idea is attractive.

3. Few of the centers have worked with each other and we must develop the network of personal relationships that underlie all collaborations. This may take years but can be accelerated with funding and government support.

4. Most of the centers are very isolated not only from each other but from the world. There is a need for the leadership, as well as the clinicians involved in the trial, to become familiar with the clinical trial world outside of China.

As always, the key to a succcessful network is leadership and communication. We certainly hope that this will be the beginning of a global network.

Wise.

[-scott-]

Thanks for the reply, Wise. It's encouraging to hear things are happening. A few further questions:

- With the possibility of an Asia-based network formed from multiple physicians and researchers from at least eight different countries, I get the feeling that dissension could easily stunt overall progress. How will/could this be combatted when it arises? ...b/c it likely will in some form or another.

- re: obstacle #1: how can placebos be utilized accurately in the first place? Each SCI is different from the next (like a snowflake). Do placebos really need to be used? Unless I'm mistaken, the main thing to look for is improvement. To me, these therapies are one-way. Either one improves, or one experiences no change. I guess one could lose health should things go wrong, but again, I don't see where a placebo patient would serve much purpose. Correct me if I'm wrong.

- Where do you fit in the picture? Are there several US doctors (or others from out-of-network) getting involved w/ the China/Asia ordeal?

[Wise Young]

Scott,

• Dissension is natural and not always bad. I've had my anti-dissension claws sharpened on carecure.

• Placebo is a tough one. Nobody wants placebo. Until recently, I did not think that people with spinal cord injury were susceptible to placebo effects since many have tried many things to treat themselves. On the other hand, if one thinks about it, the Neuralyn scam showed us that it is possible to get people who believe that a treatment works and to claim that it works even if the treatment is really nothing more than a placebo. People with spinal cord injury do improve and that improvement can change with effort put into it. In my opinion, we need to get away from placebo and compare treatments in clinical trials. If one can show that one treatment is better than another and that the treatment improves the person from before the treatment, that might convince some people. However, one can argue that there may be treatments of different placebo value. For example, a laser may have more placebo effect than a cup of tea. If one compares a laser and a cup of tea, the laser might cause significantly more improvement than the cup of tea and some people still may be skeptical that the laser is effective. So, in the end, a placebo control is the most rigorous form of clinical trial.

• My role is uncertain. I only have limited time to spend and therefore will be trying to delegate as much as I can.

Wise.

[Wise Young]

By the way, I want to give the credit for the China SCI Network to the incredible hard work of Suzanne Poon. She is a one woman special forces unit. Wise.

[-scott-]

hmm... definitely some good points. I'm just trying to get a better idea of everything going on...

In my opinion, we need to get away from placebo and compare treatments in clinical trials. If one can show that one treatment is better than another and that the treatment improves the person from before the treatment, that might convince some people

Agreed 100%. Time is of the essence!

btw, way to go Suzanne... that's no small feat!

thanks Wise. [img]/forum/images/smilies/wink.gif[/img]

~ scott

[Sfajt]

Scott,

thanks for the questions~ [img]/forum/images/smilies/wink.gif[/img]

Wise,
interesting answers! [img]/forum/images/smilies/wink.gif[/img]

i will elaborate later ont this topic, as i just found it and am on my way out the door to go have dinner! [img]/forum/images/smilies/cool.gif[/img]

Gods speed~

[Christopher Paddon]

"By the way, I want to give the credit for the China SCI Network to the incredible hard work of Suzanne Poon. She is a one woman special forces unit. Wise."

She is that!! I am in awe

Wise - in awe of you also


"Time is of the essence!" - I agree - time is slipping through our fingers - should I talk to the two neurologists in charge of the NZ Spinal Units re this network? I was going contact them in desperation anyway

[nedim]

I think placebo aproach cannot be applicable for such kind of threatment.

Personally, I cannot imagine a placebo operation:
- Just a small skin cut for not to hurt the body of the patient or,
- A deep cut and complex operation (with some risks to hurt the patient body) for noting

Nedim

[Wise Young]

Nedim, I agree with you that sham surgery (surgery where everything else is done but the treatment is not applied) is hard to justify. However, anything less is often not convincing and therefore a therapy does not get adopted by the clinical community. If it is not adopted, it doesn't become available to people. The reason for clinical trials is to prove that a therapy is safe and efficacious.

Let me describe a clinical trial with sham surgery controls. They did this in the trial of fetal cell transplants to patients with Parkinson's disease. In half of the patients, they injected fetal neurons into the basal ganglia and they injected just solution into the sham surgery control patients. However, after a year, they injected the cells into the control patients. All the patients received the therapy eventually but the sham operated patients got it a year later. Note that the study was double-blind, so that neither the patient nor the doctor knew which patient received the fetal neurons and which patient received just the solution. The study showed that although more patients that received the fetal transplant got better, some of them got worse than the worst of the controls.

Results had suggested that the fetal transplants improved the function of people with Parkinson's (see Fetal Cell Transplant Shows Promise for Parkinson's. Many people interpreted the results of the sham-controlled trial to indicate that fetal cell transplants should not be used to treat Parkonsons disease (see  Reported June 20, 2003 Transplants to Treat Parkinson's?.

It is a conundrum.

Wise.

[Sfajt]

Wise,

I too would like to ask some questions that i feel are important for us to know about.. What type of cells are being used in China and is this a combinational trial that has been used on humans before? What are the names of the doctors which hold such promise in the sci field that you are going to stay with?
Have they had success with human patients in the past or will this be the first time a trial has been conducted?
Sorry for all of the questions but i am only curious as it may help us here in the USA. Should i be getting ready to head to China? [img]/forum/images/smilies/confused.gif[/img]
thanks and Gods speed~
Susan

[Jeff]

This is fascinating. We must really try hard to get the CRPA passed into law. The US has much to contribute when it comes to clinical trials. The funds from the CRPA would go a long way.

I want to issue a huge thank-you to Wise and Suzanne Poon. Getting results back from respected, double-blinded clinical trials will be a huge step and a massive tool we can use toward getting therapies funded in the US. Imagine insurance company approval for cure therapies? It's been a dream for so long it's almost hard to believe it could ever be true. But it will!

~See you at the SCIWire-used-to-be-paralyzed Reunion ~

[poonsuzanne]

Originally posted by Wise Young:

By the way, I want to give the credit for the China SCI Network to the incredible hard work of Suzanne Poon. She is a one woman special forces unit. Wise.

Wow! Thanks, Dr. Young! You are so nice... [img]/forum/images/smilies/smile.gif[/img]

I acquired the required knowledge and the required impetus from a lot of members of this Forum, in particular, from Dr. Young, in order that I know what I should do to help my son and everyone get out of the chair sooner.

I will continue to endeavour my best until the end of the world or the last day of my life!!

Lastly, once again thanks to all the encouragement I received here!

Suzanne

[Schmeky]

Suzanne,

You're awesome! [img]/forum/images/smilies/smile.gif[/img]

[Steven Edwards]

Thanks Suzanne. You've definitely been a big help with what you can do.

There are a couple of people on the site in North America who are doing similar with their connections. They know who they are, and a big thanks goes out to them as well.

-Steven
...always want credit for some sh*t they're supposed to do. They'll brag about stuff a normal man just does. They'll say something like ... "I ain't never been to jail." Whaddya want? A cookie? You're not supposed to go to jail, you low-expectation-having ...