ChinaSCINet Update

[greenseed]

Thanks for that info Jim.

Im a bit confused with the Expanded Compassionate Use part though.
As soon as subjects are chosen for the India and US trials ANYONE can have the procedure done in those countries as long as they can pay & find someone & somewhere to do the procedure? If that is correct i imagine there would be only specific places this could be done. If so where would those places be? Would it be difficult to acquire the right cells at this time?

[Mize]

Also, can the intensive training be done outside the program (aka, with PTs nearer to home).

[nphuskers]

When you say anyone can apply for the expanded compassionate use, does that include C's and D's who don't fit the trial criteria?

150K won't allow me to try regardless though.

Thanks for the updates Jim.

[Jim]

Thanks for that info Jim.

Im a bit confused with the Expanded Compassionate Use part though.
As soon as subjects are chosen for the India and US trials ANYONE can have the procedure done in those countries as long as they can pay & find someone & somewhere to do the procedure? If that is correct i imagine there would be only specific places this could be done. If so where would those places be? Would it be difficult to acquire the right cells at this time?

Yes, must find a qualified neurosurgeon. The best choice would be one who performed the procedure in our trial. The cells will be provided by StemCyte at cost, shouldn't be a problem finding a matching unit.

Also, can the intensive training be done outside the program (aka, with PTs nearer to home).

Yes

When you say anyone can apply for the expanded compassionate use, does that include C's and D's who don't fit the trial criteria?

I'm not sure if we need to do a trial of incompletes before the FDA will allow Compassionate Use for Incompletes.

150K won't allow me to try regardless though.
Fees with Dr's, hospitals, and rehab centers are negotiable. You can also try to get insurance to pitch in. In all 6 ChinaSCINet trials, not one Dr. was paid.

Thanks for the updates Jim.

[greenseed]

Thanks for the info Jim. Forgive me if this is to forward of a question but are you going to apply for Compassionate Use and get this treatment done if it goes through?

I wonder how worth it it would be to get the cell treatment but do no PT and walking training. As in would bladder bowel function improve without those aspects? I would imagine they might but who knows. Im going to look at the HK results again to see if theres anything in there that speaks to that.

[lunasicc42]

*bangs desk angrily and whinily" GIMME GIMME GIMME! HOW MUCH LONGER!
But really I think this therapy is the one that will be most optimal for me because I require detethering and it's part of this procedure...need that before I can do anything

And a question maybe for SCI-Nurse: although no doctor would perform an actual detethering on me but decided to take the safer way out and place a shunt in it but not before the syrinx rised and totally took out what little function I had in my left arm...do you think detethering and the Scinetusa procedure has the potential to bring my left arm function back or is that gone forever?

SCI-Nurse or Jim

[Jim]

Thanks for the info Jim. Forgive me if this is to forward of a question but are you going to apply for Compassionate Use and get this treatment done if it goes through?

I wonder how worth it it would be to get the cell treatment but do no PT and walking training. As in would bladder bowel function improve without those aspects? I would imagine they might but who knows. Im going to look at the HK results again to see if theres anything in there that speaks to that.

The first 8 subjects were transplanted in HK but only received regular PT. Some showed growth across the injury site and regained some sensory but no walking, bowel, or bladder function.

I don't have 150K and already have bowel/bladder.

luna, we don't yet know if this therapy will restore arm function because we didn't exercise arms/hands/fingers. We will in the IIb trials.

[lunasicc42]

Did my questions about needing detethering make any sense? I am really concerned about that syrinx and what will need to happen

[Ajstevens]

If you would have read further back in this thread you would have seen that Wise's paper was published based on the 2 clinical trials in Hong Kong and China. The participants had chronic, complete injuries. They received escalating dose injections of umbilical cord mononuclear cells into their spinal cords, above and below the injury. In Hong Kong, 8 patients were injected, and the participated in regular physical therapy. Some recovered 1-2 sensory levels of feeling. At a year, some showed growth across their injury site. No other recovery occurred.

At the Kunming Army Hospital, 20 patients received the escalating dose injections and all participated in the intense walking program for 3-6 months. 75% of these patients recovered assisted walking. (Some with rolling/upper body supporting walker, others with 4 point walkers). MRI's of the spinal cord were taken at different time points. At one year, some patients showed growth across the injury site. Also at a year, 60% began to regain bowel and bladder function.

Here's the paper- http://www.ingentaconnect.com/search...ize=10&index=7

Based on these results, this trial is being repeated this year in India, Taiwan, and the US.

Sounds promising. Believe myself and others would really benefit if this were on the news or spacebook.... why isn't it ? I know if my family or my town seen someone that was hurt and couldn't walk and seen video of someone walking who previously couldnt then it would be A LOT easier to raise funds.....

I think I would be able to get the $ if there were hard stone cold FACTS or VIDEOS.... and to all that say im negative, not at all just real. Actually live a pretty busy life. Going to gym, school, then ill be fishing in a tournament... just a mind boggling thing that with all technology we are still in the chairs and will be more then likely forever.

will check back in when I see something on news, maybe another 6 years

[Jim]

We will publicise when the trial is approved by the FDA.

The funds for the trial should not be an issue.

[lunasicc42]

Was it fall or winter? The estimated time of the trial start?

[Jim]

fall/winter

[tumbleweeds]

India & Taiwan Phase IIb trial- 18 subjects each, 2 groups- Group 1: cord blood injections + intensive walking, Group 2: cord blood + lithium + walking. They will to start this year, Taiwan prob first.

Is China doing a IIb trial as well? I saw where they have lifted the restrictions on stem cell processing and suppliers.

I had a monkey that shit money but I traded him for some magic beans and they're not growing yet. Any idea on the chances of insurance covering the cost of this?

[Jim]

Is China doing a IIb trial as well? I saw where they have lifted the restrictions on stem cell processing and suppliers.

I had a monkey that shit money but I traded him for some magic beans and they're not growing yet. Any idea on the chances of insurance covering the cost of this?

I think the plan is to have China take part in the phase 3.

If approved after phase III, most likely, insurance will pay for it.

[jcalix]

I think the plan is to have China take part in the phase 3.

If approved after phase III, most likely, insurance will pay for it.

hello Jim, I have few questions after Phase III how long it takes to became comercial?
and if you know how much approx. the therapy will cost for those who don't have insurance? thanks