Spinal Cord Injury Network USA (SCINetUSA)

[Brad]

"The inclusion criteria will be 18-64 years, C5 through T10, able to stand in a standing frame for at least one hour per day, and informed consent."

Are ASIA A or B still required

[Leif]

To use so-called none controversial cells – hey, to use any cells. I could pick any pubmed studies and say to the community – hey come on. But why the non-compliance. One can’t take pubmed, inject it to a chronic cord and say it will be ok. The discussions have become Dr. Geeta Shroff alike, which I thought was scrutinised and discussed seriously. Many then flies around the world with CC followers advocating for UCB injections, which does not make anything any better. In fact, it does not help research for SCI, because SCI and more SCI research are not mentioned! I give up.

[Leo]

Knowing this I think we sci should have our letters of support ready come public comment time.

Someone up to drafting a generic sample we could use.

It is hard to predict what the FDA will do. We are using non-manipulated umbilical cord blood cells (just isolated mononuclear cells) and lithium should not pose any safety issues. We are also using cells provided by the best umbilical cord blood company that has provided over 1000 units of cells for transplantation for other conditions (hematopoietic and oncological conditions). So, one would expect relatively fast approval. However, because there have been very few non-autologous transplantations approved by the FDA in the past decade, they may require additional animal safety. We will go ahead as fast as we can.

As far as when the treatment will be available to the general population, much depends on the results. If we have robust results indicating safety and benefit, I expect that there will be rapid availability.

Wise.

[capt'n mark]

Has lithium and umbilical cord blood been effective in rats? Are there any positive results from the trials in China?

[Wise Young]

Has lithium and umbilical cord blood been effective in rats? Are there any positive results from the trials in China?

Both umbilical cord blood and lithium have had positive results on their own in trial. The trials are just starting and therefore no results are available. Wise.

[cdurfee99]

dr. young

dr. young-
in your estimation, how brilliant is your neighbor dr. kerr?

[Solan]

I just donated $ 365 on the JustADollarPlease.org website and hope it's not just me doing so.
I'm tired of sitting on my ass.

We are currently creating the SCINetUSA website and are going live ASAP. Once the website is live I well be sending out an eNewsletter that will direct people to the JustADollarPlease.org website where they can donate.

Please send me your emails so you can pass the newsletter on to your friends/family. jimbenn@rci.rutgers.edu

Read this post by Dr Young that outlines our fundraising goals-

[Wise Young]

dr. young-
in your estimation, how brilliant is your neighbor dr. kerr?

Dr. Kerr is brilliant, amongst the most brilliant of my friends. Wise.

[mckeownp]

I just donated $ 365 on the JustADollarPlease.org website and hope it's not just me doing so.
I'm tired of sitting on my ass.

how did U do it I google dollar please... got crazy results ...I have Visa

[mckeownp]

how did U do it I google dollar please... got crazy results ...I have Visa

confusing options what do I do?

[Leo]

confusing options what do I do?

www.justadollarplease.org

[Charles Hansen]

Many then flies around the world with CC followers advocating for UCB injections, which does not make anything any better. In fact, it does not help research for SCI, because SCI and more SCI research are not mentioned! I give up.

Hi Leif,

I'm a little late to this thread, so maybe I'm missing something. But if I understand you correctly, SCINet is proposing to take two therapies that have shown minor promise and then go straight to human trials with a combination of them.

I have to say that I don't understand the wisdom of this, nor the enthusiasm this has generated, nor the reason to donate $30 million for this "grand experiment".

1) Wouldn't it make more sense to try the UCB + lithium combination out on rats first for, say, $1 million? It wouldn't delay things by more than a year or so. It will probably take at least a year just to raise $30 million.

2) If we are raising $30 million for SCI research, wouldn't it make more sense to give it to the programs that have already demonstrated more robust results?

3) As can be seen at:

http://www.stemcyteinc.com/about/management.html

Dr. Young is part of the (presumably paid) management team for StemCyte, the company that is supplying the UCB's for this experiment. Unless they are donating them, this would seem to be a conflict of interest. Most universities require that their researchers take a leave of absence before working at a for-profit outside venture.

What am I missing?

[Buck503]

Hi Leif,

I'm a little late to this thread, so maybe I'm missing something. But if I understand you correctly, SCINet is proposing to take two therapies that have shown minor promise and then go straight to human trials with a combination of them.

I have to say that I don't understand the wisdom of this, nor the enthusiasm this has generated, nor the reason to donate $30 million for this "grand experiment".

1) Wouldn't it make more sense to try the UCB + lithium combination out on rats first for, say, $1 million? It wouldn't delay things by more than a year or so. It will probably take at least a year just to raise $30 million.

2) If we are raising $30 million for SCI research, wouldn't it make more sense to give it to the programs that have already demonstrated more robust results?

3) As can be seen at:

http://www.stemcyteinc.com/about/management.html

Dr. Young is part of the (presumably paid) management team for StemCyte, the company that is supplying the UCB's for this experiment. Unless they are donating them, this would seem to be a conflict of interest. Most universities require that their researchers take a leave of absence before working at a for-profit outside venture.

What am I missing?

Yeah, what's another year? What the hell, how 'bout the standard
five more?

Seriously, don't be surprised if Leif is the only one who agrees with
you that any research should be held up longer than necessary.

[paolocipolla]

What am I missing?

You should meet prof. Wise Young as soon as you have an opportunity

[Charles Hansen]

Yeah, what's another year? What the hell, how 'bout the standard
five more?

Seriously, don't be surprised if Leif is the only one who agrees with
you that any research should be held up longer than necessary.

Like I said, I'm late to this thread, so maybe I'm missing a few things. But given that fact that the SCI community has limited resources to work with, it's not clear to me that spending $30 million for a completely unproven combination of therapies is the best use of funds.

It seems like everyone is excited about "human trials". And we should be. That is what is going to get us out of our wheelchairs. I'm just asking, "Is this the best human trial to start with?"

And I'm also asking if there is a conflict of interest when one of the principal investigators is on the management team of the company that is supplier of the biological agents (UCB's). Obviously that company has a profit-based motive. There is nothing wrong with that -- *all* companies do. But it seems to me that relationship should be disclosed.

As far as delays go, why not run the experiment on rats while the $30 million is being raised? That way there won't be any additional delays....