ChinaSCINet Update

[Leif]

No, they are now focusing in saving the planet and stuff like that

Saving the planet is also important Isildur , but back to SCI therapies; from over here several chief physicians from our SCI-units, chief neurosurgeons from our National Hospital (Rikshospitalet), professors in basic science and in neuroscience and I and another fellow in a wheelchair will go. We are very much looking forward to this.

[lunasicc42]

yeah sorry for that. I got ahead of myself

[Leif]

yeah sorry for that. I got ahead of myself

Ok, good or bad -we are going (to many places), but if you are negative we call it off. No problems.

[Tetracyclone]

Forgive me if this question has been answered. Is there a part of the phase 3 design that allows you to compare a group of SCId individuals receiving the cells and lithium and intensive therapy with another group that is getting the treatments but no PT? or would you just compare to a group getting only intensive PT? The second may be more ethical.

[Wise Young]

Forgive me if this question has been answered. Is there a part of the phase 3 design that allows you to compare a group of SCId individuals receiving the cells and lithium and intensive therapy with another group that is getting the treatments but no PT? or would you just compare to a group getting only intensive PT? The second may be more ethical.

Tetracyclone,

We are still working on the phase 3 design. At the present, in CN103 (the ChinaSCINet trial), we are planning to transplant umbilical cord blood mononuclear cells (UCBMC) into 400 subjects and randomize two groups of subjects with ASIA Impairment Scale (AIS) A, B, or C chronic spinal cord injury to a 6 week course of placebo or lithium. The latter will be "blinded" or "masked" so that neither the doctors nor patients know whether the patient is getting placebo of lithium.

The problem, as you point out, is how to deal with and assess the role of rehabilitation. We encourage every participating center to provide intensive locomotor training. That is not possible, however. So, we are planning to do three things to ascertain whether the walking training is important:

1. In the trials, we will monitor intensity of locomotor training with a daily diary by the patient (emailed daily by the patient to the testing center) and also a pedometer (or other device to measure hip movement).
2. In the upcoming U.S. phase 2 trial (US102 in Austin), we are planning to randomize patients to standard rehabilitation and a more intensive walking program after treatment.
3. In the upcoming ChinaSCINet Phase 3 trial (CN103), we will randomize subjects to intensive or standard locomotor rehabilitation. To do the latter, the subjects will go to Kunming.

We are hoping to get US102 started in Austin (TX) early in 2012, to assess how feasible it would be to do 6 hours a day for 5 days a week training.

Wise.

[Barrington314mx]

has recruitment already started for the US phase 2 in austin, tx? im sure there will be no shortage of patients for it, im just wonder about time to go through all those apps.
especially when you move to 400 in phase3. thats gotta take some serious time to review all those people.

[Jim]

Barrington, recruitment hasn't started yet but when it does we will let you know.

400 patients won't be that bad when divided by 8 - 10 centers.

[Jawaid]

Good news that trials have started in china.

Is it possible for you Dr Wise to include lower injuries in trials? May be they can also get function back who knows.

[0xSquidy]

Good news that trials have started in china.

Is it possible for you Dr Wise to include lower injuries in trials? May be they can also get function back who knows.

Trials in china started months ago. And how many times will you ask Wise to include your injury in the trial? He answered specifically to you like a milion times.

Take it easy dude, just asking is not gonna cure you faster.

[Jawaid]

Ox u r right my dear. I am sorry but bit frusteration u know.

May be Dr Wise can expand trials criteria later to include lower injuries that is why asking.

[Barrington314mx]

im pretty sure he has explained why they cant take higher or lower injuries, and have also stated that at a later date they would try to include them and older and younger patients. im sure its in this 45 page thread somewhere.

[Mrs770]

Does anyone know how many patients have had the procedure?

[Barrington314mx]

Does anyone know how many patients have had the procedure?

approximately 8 or 9 in hong kong so far and 2 in kunming.

[Imight]

Tetracyclone,

We are still working on the phase 3 design. At the present, in CN103 (the ChinaSCINet trial), we are planning to transplant umbilical cord blood mononuclear cells (UCBMC) into 400 subjects and randomize two groups of subjects with ASIA Impairment Scale (AIS) A, B, or C chronic spinal cord injury to a 6 week course of placebo or lithium. The latter will be "blinded" or "masked" so that neither the doctors nor patients know whether the patient is getting placebo of lithium.

The problem, as you point out, is how to deal with and assess the role of rehabilitation. We encourage every participating center to provide intensive locomotor training. That is not possible, however. So, we are planning to do three things to ascertain whether the walking training is important:

1. In the trials, we will monitor intensity of locomotor training with a daily diary by the patient (emailed daily by the patient to the testing center) and also a pedometer (or other device to measure hip movement).
2. In the upcoming U.S. phase 2 trial (US102 in Austin), we are planning to randomize patients to standard rehabilitation and a more intensive walking program after treatment.
3. In the upcoming ChinaSCINet Phase 3 trial (CN103), we will randomize subjects to intensive or standard locomotor rehabilitation. To do the latter, the subjects will go to Kunming.

We are hoping to get US102 started in Austin (TX) early in 2012, to assess how feasible it would be to do 6 hours a day for 5 days a week training.

Wise.

Awesome! now this is what I like to read. promising news. Can't wait!

[Wise Young]

approximately 8 or 9 in hong kong so far and 2 in kunming.

Another two received cells in Kunming for a total of 4 chronic patients in Kunming. Wise.