Spinal Cord Injury Network USA (SCINetUSA)

[Tufelhunden]

In 2010, we proposed to do the following trials in the U.S.
US102. Phase II trial of UCBMC+Lithium±Rehab in 20 subjects.
US103. Phase III trial: Rehab, Rehab+Ltihium, Rehab+UCBMC, Rehab+UCBMC+lithium, 120 subjects.
US104A. Phase II trial of UCMBC+lithium±rehab in 20 young subjects (8-17 years old).
US104B. Phase II trial of UCBMC+ltihium±rehab in 20 older subjects (65-80 years old).
US104C. Phase II trial of UCBMC+lithium±rehab in 20 subjects with high cervical injuries (C1-C4).

I take it that 104A and 104B will be concurrent?

[Barrington314mx]

In 2010, we proposed to do the following trials in the U.S.
US102. Phase II trial of UCBMC+Lithium±Rehab in 20 subjects.
US103. Phase III trial: Rehab, Rehab+Ltihium, Rehab+UCBMC, Rehab+UCBMC+lithium, 120 subjects.

Wise.

in US 102, will those 20 subjects be broken up into groups with lower dosage of cells or lithium?

and in US103, basically the same question. im assuming 30 subjects in each group. but then is there a subgroup of different dosages?

hope that made sense.

[ineedmyelin]

Unfortunately, Dr. Charlotte Smith who was our investigator at Brackenridge has left that hospital. So, we are currently considering several options, including not doing US102 or doing US102 in New Jersey instead. We, however, are continuing to plan to initiate US103 in 2013.

Wise.

Dr Young, does this mean that Brackenridge is out?

[Wise Young]

Hi Dr Young, if this phase II is moved to jersey where would the surgeries be performed?

Bob Heary at UMDNJ Newark has indicated that he will do the surgery. We are still discussing. Wise.

[Wise Young]

Dr Young, does this mean that Brackenridge is out

No, it means what I said. I don't think that we can get the trial started in Brackenridge within 2012. Much depends on whether we can find another investigator soon and whether we raise the funds of the trials. Wise.

[Wise Young]

in US 102, will those 20 subjects be broken up into groups with lower dosage of cells or lithium?

and in US103, basically the same question. im assuming 30 subjects in each group. but then is there a subgroup of different dosages?

hope that made sense.

Barrington, the final design of the trial depends on both investigators and FDA agreeing. I am just listing what we proposed in 2010 to do. Wise.

[Wise Young]

I take it that 104A and 104B will be concurrent?

Hi, Tufelhunden. These are being done in different hospitals and therefore there is no linkage. Wise.

[Wise Young]

We are continuing to work on seeing if we can do the planned trial at Brackenridge. In the meantime, we are working hard on getting a trial going at UMDNJ Newark, Kessler Rehabilitation Institute, and the East Orange VA Hospital. The details are still being discussed and I will post them as soon as they become solidified.

Wise.

[Ameli2005]

US104A. Phase II trial of UCMBC+lithium±rehab

When is this trial going to take place ...... my daugther is 7 at the moment but if the trial starts in 2013 she'll be 8.

I'm going to google it right now!!

Please let me know!

Best regards,
Inci
mom of Ameli

[Wills77]

Wise if you do start trials at kessler in 2012 will it include asia B and C or just asia A patients?

Thanks

[jmeyers7]

Dr. Wise, Have you contacted TIRR in Houston, Texas regarding clinical trials? I know they do allot of clinical trials and have been in the top 5 Rehab Institutes since the 80's. They helped Congresswoman Gifford and quite a few other celebrities/NFL players etc.

Keep up the good work

Thanks, JM
C-4/C-5 Asia B,Incomplete Quad

[Wise Young]

Wise if you do start trials at kessler in 2012 will it include asia B and C or just asia A patients?

Thanks

Wills77, it is currently only for ASIA A. Wise.

[Wise Young]

Dr. Wise, Have you contacted TIRR in Houston, Texas regarding clinical trials? I know they do allot of clinical trials and have been in the top 5 Rehab Institutes since the 80's. They helped Congresswoman Gifford and quite a few other celebrities/NFL players etc.

Keep up the good work

Thanks, JM
C-4/C-5 Asia B,Incomplete Quad

JM,

Thanks for the recommendation. I am very familiar with TIRR, of course. I think highly of them. Given that we don't have sufficient money for clinical trials and most institutions expect to be paid to run clinical trials, it is difficult to approach institutions to participate in trials. It would be a lot easier if we had the funds. Lots of hospitals would want to join, including TIRR.

Brackenridge had originally approached me two years ago to be involved in the trial. The Lone Star Foundation indicated their interest in supporting the trial. In fact, Governor Rick Perry indicated his support of the trial. They have a very good "recovery center" that was interested and willing to test the intensive walking training. They sent doctors to China to observe the surgery and walking program.

We held an Open House in Austin about 2 years ago and talked about doing the trial in Austin to the community. The community has been waiting patiently for the trial. For that reason, I don't want to give up yet, even though we currently lack a principal investigator and surgeon for the trial. I am sure that we can find others. We also need to raise the funds.

Wise.

[mcferguson]

JM,

Thanks for the recommendation. I am very familiar with TIRR, of course. I think highly of them. Given that we don't have sufficient money for clinical trials and most institutions expect to be paid to run clinical trials, it is difficult to approach institutions to participate in trials. It would be a lot easier if we had the funds. Lots of hospitals would want to join, including TIRR.

Brackenridge had originally approached me two years ago to be involved in the trial. The Lone Star Foundation indicated their interest in supporting the trial. In fact, Governor Rick Perry indicated his support of the trial. They have a very good "recovery center" that was interested and willing to test the intensive walking training. They sent doctors to China to observe the surgery and walking program.

We held an Open House in Austin about 2 years ago and talked about doing the trial in Austin to the community. The community has been waiting patiently for the trial. For that reason, I don't want to give up yet, even though we currently lack a principal investigator and surgeon for the trial. I am sure that we can find others. We also need to raise the funds.

Wise.

When I learned that the trial was in danger of not happening, I emailed Gov. Perry. I'm not sure what he or the governor's office could do. I haven't heard back, yet.

[jmeyers7]

JM,

Thanks for the recommendation. I am very familiar with TIRR, of course. I think highly of them. Given that we don't have sufficient money for clinical trials and most institutions expect to be paid to run clinical trials, it is difficult to approach institutions to participate in trials. It would be a lot easier if we had the funds. Lots of hospitals would want to join, including TIRR.

Brackenridge had originally approached me two years ago to be involved in the trial. The Lone Star Foundation indicated their interest in supporting the trial. In fact, Governor Rick Perry indicated his support of the trial. They have a very good "recovery center" that was interested and willing to test the intensive walking training. They sent doctors to China to observe the surgery and walking program.

We held an Open House in Austin about 2 years ago and talked about doing the trial in Austin to the community. The community has been waiting patiently for the trial. For that reason, I don't want to give up yet, even though we currently lack a principal investigator and surgeon for the trial. I am sure that we can find others. We also need to raise the funds.

Wise.

Dr. Wise, Thank you for responding. I had 2 phases on TIRR's step program and gained some fuction in my lower left abdomen and can feel when my bladder is full. It was hard work, but well worth it! Next time I see my SCI Specialist at TIRR I am going to let them know about your research. I dream of tthe day I can wiggle my toes, keep up the good work. JM