Announcement

**Tufelhunden** · 20 Apr 2009, 2:49 PM

Looks good Jim. I'm not sure how I can help being up to my nose in graduate economics and math, but I'm sure there will be a positive reaction to this. Thanks for your hard work.

**kickingber** · 20 Apr 2009, 3:00 PM

what do you need, where you need it?

**Chaz19** · 20 Apr 2009, 8:03 PM

Hi Jim- it sounds like a promising venture. I'd like to get involved in some aspect. On the website that you posted, it states that FDA approval could be sought by mid-2010. With adequate funds are trials possible this year?

**rjames** · 20 Apr 2009, 10:11 PM

I agree, let's get started. It's about time we do something as it relates to chronic SCI human clinical trials. Why would the Christopher Reeve foundation not be interested in helping with this? After all aren't they the figure head of our community with the public at large?

The question I have is why do we need to setup a new,different or seperate clinical trial network? What network is Geron going to use? What happened to http://www.christopherreeve.org/site...al_Network.htm ? I can't get the link to work, click on research on the home page , scroll down to clinical trials on the lower left of the screen and look for "Reeve Foundation North-American Clinincal Trials Network"

With times as tough as they are and money hard to come by shouldn't we be pooling our resources?

**carbar** · 21 Apr 2009, 4:56 AM

Originally posted by rjames View Post

I agree, let's get started. It's about time we do something as it relates to chronic SCI human clinical trials. Why would the Christopher Reeve foundation not be interested in helping with this? After all aren't they the figure head of our community with the public at large?

The question I have is why do we need to setup a new,different or seperate clinical trial network? What network is Geron going to use? What happened to http://www.christopherreeve.org/site...al_Network.htm ? I can't get the link to work, click on research on the home page , scroll down to clinical trials on the lower left of the screen and look for "Reeve Foundation North-American Clinincal Trials Network"

With times as tough as they are and money hard to come by shouldn't we be pooling our resources?

Good questions. I too was wondering about what network was already in place that facilitated Geron to go ahead with their trial.

**DreamersWillRide** · 21 Apr 2009, 6:52 AM

Would this be a continuation of this?:

https://www.carecure.net/forum/showt...111745&page=15

Please excuse my lack of a clue if that is the case

**Jim** · 21 Apr 2009, 11:19 AM

Hi everyone,

It is great to see all the excitement and willingness to step up and make these trials happen ASAP!

Our plan is to fund the Spinal Cord Injury Network USA (SCINetUSA) with many small donations from those with SCI, their families and friends. And of course we would be glad to accept LARGE donations

We are asking that people donate 1 dollar per day. According to a national population paralysis survey released today by Reeve Foundation, there are 1.3 million people with SCI in the U.S. We have the numbers to fund SCINetUSA trials.

kickingber- The role of The Clinical Trial Support Squad is to bring the SCI Community together. We have pages set up on MySace, FaceBook and Twitter where donations will be accepted. The SCINetUSA website is being tweaked and will soon be ready to go. All of the Hospitals/Rehab Facilities taking place in the clinical trials will have their own websites where people can donate directly. We need to bring people to these websites for the purpose of donating. It is referred to as viral fundraising. When we are ready to launch, I will let you all know. In the meantime, please send me an email so I can add you to the list. jimbenn@rci.rutgers.edu

Chaz, I believe if the funding is in place, participating centers can begin the observational phase this year. This depends on many factors, Dr Young might want to respond...

rjames/carbar, I'll let Dr Young answer your question.

DreamersWillRide, sorry for the confusion. In the thread you posted, they took the initiative and started raising funds for SCINetUSA. I can see by the the enthusiasm, we will be raising much money! Unfortunately, we haven't been able to launch the fundraising campaign yet, and will be in China this and next week observing the clinical trials. I will be posting my adventures in China, in this forum I guess starting Sat.

Please email me if you want to be part of the Clinical Trial Support Squad.

**Wise Young** · 21 Apr 2009, 1:32 PM

Jim is referring to the North American Spinal Cord Injury Network where we will be starting clinical trials for people with chronic spinal cord injury in the United States. At the present, eight centers have expressed strong interest in doing the clinical trials. We are holding investigator meetings, raising funds, submitting applications, and organizing training workshops this summer. We are hoping that the centers will start recruiting subjects for the trials this fall. The first phase of the trial will be a 6-month observation period during which subjects are strongly encouraged to start standing at least an hour per day. We hope to initiate the treatment phase of the trial in the third quarter of 2010. The trial will compare the effects of intraspinal transplants of umbilical cord blood mononuclear cells (UCBMC transplant), the UCBMC transplant plus lithium, or rehabilitation alone. More details can be found at http://nascinet.org.

Wise.

**Wise Young** · 21 Apr 2009, 1:47 PM

Originally posted by carbar View Post

Good questions. I too was wondering about what network was already in place that facilitated Geron to go ahead with their trial.

Barbara,

The Geron trial is not being done by a "network". It is just a multicenter trial. A network is a standing group of centers that agree to work together to test therapies and to carry out multiple trials. While a multicenter clinical trial may involve many centers, it may not be a network. For example, the first spinal cord injury network that was formed was the National Acute Spinal Cord Injury Study (NASCIS) that I helped formed to test methylprednisolone, naloxone, tirilazad mesylate from 1978-1998. In the late 1990's, Acorda Therapeutics carried out various Fampridine trials with a network of over 82 spinal cord injury centers. In 2003, we formed the ChinaSCINet which consists of about 25 centers in China, Hong Kong, and Taiwan.

NACTN (North American Clinical Trial Network) was formed by the Christopher and Dana Reeve Foundation. As many here know, I am a strong supporter of the Christopher and Dana Reeve Foundation. NACTN is currently recruiting subjects for an acute spinal cord injury treatment trial. NASCINet is testing therapies for chronic spinal cord injury and will be carrying out trials that parallel those being done at the ChinaSCINet.

Wise.

**Wise Young** · 21 Apr 2009, 1:53 PM

Originally posted by Chaz19 View Post

Hi Jim- it sounds like a promising venture. I'd like to get involved in some aspect. On the website that you posted, it states that FDA approval could be sought by mid-2010. With adequate funds are trials possible this year?

Chaz, we will be training the investigators and initiating a 6-month observational trial this fall. The treatment phase of the trial begins in Q3 of 2010. We have set a very ambitious schedule of raising the funds, obtaining regulatory approval, organizing and training the centers, and recruiting the subjects in the coming 6 months. We developed the observational trial approach in the ChinaSCINet to obtain repeated examinations of the subjects over a 6 month period before initiating treatment.

Wise.

**Wise Young** · 21 Apr 2009, 2:06 PM

Originally posted by rjames View Post

I agree, let's get started. It's about time we do something as it relates to chronic SCI human clinical trials. Why would the Christopher Reeve foundation not be interested in helping with this? After all aren't they the figure head of our community with the public at large?

The question I have is why do we need to setup a new,different or seperate clinical trial network? What network is Geron going to use? What happened to http://www.christopherreeve.org/site...al_Network.htm ? I can't get the link to work, click on research on the home page , scroll down to clinical trials on the lower left of the screen and look for "Reeve Foundation North-American Clinincal Trials Network"

With times as tough as they are and money hard to come by shouldn't we be pooling our resources?

RJames,

I think that we need to have as many clinical trials as possible. At least two companies have announced clinical trials of subacute spinal cord injury: Geron (embryonic stem cells) and Alceres (Cethrin).

NACTN is currently studying the natural course of spinal cord injury in the first 12 months [source]http://clinicaltrial.gov/ct2/show/NCT00178724?term=nactn&rank=1[/source] and, since 2009, they are planning to test riluzole treatment of acute spinal cor dinjury [source]http://clinicaltrial.gov/ct2/show/NCT00876889?term=spinal+cord+injury&rank=5[/source].

NASCINet is focused on chronic spinal cord injury, which we define as more than a year after injury and at least 6 months of stable neurological status. NASCINet will be initially doing trials in parallel with ChinaSCINet, assessing umbilical cord blood mononuclear cell transplant and lithium.

Wise.

**Wise Young** · 21 Apr 2009, 10:55 PM

Somebody asked for the names of centers that are involved in NASCINet. So, far, we are discussing the clinical trial with the following organizations:

• New Jersey Medical School and Kessler Institute of Rehabilitation.
• Thomas Jefferson School of Medicine and Magee Rehabilitation.
• Shriner's Hospital in Philadelphia
• Brackenridge Hospital in Austin
• Mt. Sinai Hospital in New York City
• Long Island Jewish Hospital in Long Island
• Shepard Rehabilitation Center in Atlanta, Georgia
• Wayne State University in Detroit, Michigan
• University of Colorado in Denver

I want to emphasize that this is still at the stage of "discussion". We are having investigator meetings right now, exploring what can and cannot be done. The trials have been proposed to the investigators and we have had substantitive discussions. There are still major obstacles that must be overcome, including finalizing the clinical trial protocol, application for regulatory approval, training and vetting of the centers, and successful fundraising.

I am in China now and about a dozen investigators from the centers will be attending meetings in Beijing and Kunming, to see what is being done in China and to participate in a consensus conference to determine the rehabilitation protocol can and should be in the United States for the trial.

Wise.

**Wise Young** · 21 Apr 2009, 10:58 PM

I am renaming this topic to North American Spinal Cord Injury Network and sticking it, so that it can become a resource. I am getting a lot of the same questions asked over and over again. People should also check out http://nascinet.org

Wise.

**NancyR** · 22 Apr 2009, 11:21 AM

Dr. Young
The plan of having actual clincial trials in the US that provide a treatment for chronic injury is very exciting.
Your saying the first phase would be 6 months of observation of people standing?
I don't understand the reason for this, maybe I am missing something.
How much would that cost and couldn't that money raised be better used to go to an
actual treatment phase trial?

Announcement

Spinal Cord Injury Network USA (SCINetUSA)

Spinal Cord Injury Network USA (SCINetUSA)

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