That is good so neurosurgeon can do as they believe is better (which will make them happy :) ) with methylprednisolone, but that will add complexity to the study as they will have to analize the data - also - dividing patient who got MP from the ones who didn't so I guess we'll have:
1) patients who get 13837 + MP
2) Patients who get placebo + MP
3) Patients who get just 13837
4) Patients who get just placebo

I hope 13837 will produce strong unquestionable recovery otherwise I can see future endless discussions between clinicians & researchers around 13837... like still happens with methylprednisolone.

A clinical trial with EPO vs Methylprednisolone has started in Italy, but is now suspendedhttp://clinicaltrials.gov/ct2/show/NCT00561067?term=EPO+Spinal+cord+injury&rank=1It was a multicenter study. More then 10 centers were supporse to partecipate. First problem was to get all the centers to agree on the protocol and to have the approval of the ethical commettee of the centers.. Most of the centers never got out of these problems.
The few patient enrolled (about 15) can't provide usefull data. The study was suppose to give EPO or methylprednisolone (MP) within 8 hrs after SCI.
One big problem is that here in Italy MP was mandatory (now just strongly racommended) by the legal protocols, so many doctors refused not to give MP
According to Prof. Gorio MP neutralize the benefical effect of EPO.
In some cases EPO was given after MP.
So as I know few patiant got MP, few got EPO and few got MP+EPO.
The number of patients enrolled was too small to provide significant data.
My conclusion:
1) Doing a clinical trial in acute SCI it's complicated, expencive, takes forever, and results are easily questionable like with MP in the 90's
2) EPO at best has a mild effect in acute SCI, so why should the SCI community (that has chronic SCI) and the SCI orgs (that are supported by people with chronic SCI) give a damn about it?

Paolo

Good points Sam!
About two years ago a guy from Novartis told me that if Nogo wasn't going to work well enoug to make it to market Novartis was going to retire from SCI.... and from the way he told me that it seemed to me the decision was almost taken.
I do agree with the way forward suggested by Schwab and Buchli to save money especially if we are talking about chronic SCI trials.
In fact I desagree with Wise Young and otheres on the need of big clinical trial networks to do trials involving people with chronic SCI as they can travel easily to a clical trial center even if is my hrs of flight away.

The point with chase IMO is that they could just start and do 10 people injecting Chase. There are enough positive preclinical data that this way many people could get a functional benefit. Then, depending on the results, they may move forward to phase III or do another phase I/II administering Chase in other ways to see if there is a better indication of safety & efficacy. Then they could move to Phase III just with what seem to work better.
(Novartis, for example, has done two pase I/II with the NOGO antibody with differet ways of administration as I know)

To do that some non profit orgs should sponsor at least in part the trial because Acorda will just wait (years or decades) to find out what the more profitable way to address the scar issue is before going into clinical trials.

Paolo

I think it was a good report, but perhaps it looked driven by the "status quo". We know the academc sistem and the FDA are not as efficent as they could be in making new therapies availabe. That makes it very easy for fake doctors & clinics to enter in the 21st Century Snake Oil business.
I would have asked the opinion of a few more respected researchers and also I would have given more info on current clinical trials involving stem cells to provide a better educative picture of the field.
The solution to run out of buseness fake clinics & docs is not in fighting them, but it is providing new effective therapies faster to people. The process can be speeded up a lot as the AISD people did. If they didn't challenge the sistem in the 80s & 90s people with AIDS probably wuold still be dying as in the 80s.