Brainstorm stem cell trial

[Vikman]

It looks like the phase I/II stem cell studies were very promising. Interested to see where they go from here.

 

[Nuts]

Is it safe to get excited about this? It's sad that I'm at the point that I just smile and say how wonderful for those who come after. People keep asking if I've read about this and I think they are expecting me to say we're pursuing it and expect a miracle. I hate to keep explaining the timelines for new drugs and treatments.

 

[BlueandGold]

Nuts you are spot on with your observation on this. I continually have family members and a few friends email me articles or clips from the evening news about promising results from stem cells and they always end with the same comment, "you need to get this treatment as soon as possible". The articles and news clips never tell the complete story which is that this is not available to current ALS patients and will likely not be for years to come. Yes it is hopeful for those who will come after but not for us.

Vince

 

[chally]

Ditto Vince and Becky, I get overwhelmed often with all the " cures" and then wonder what really holds up finding a cure.

 

[Vikman]

Any chance of this stem cell trial going into a larger phase III trial soon? Maybe by the end of the year or not even close?

 

[notBrad]

Ditto Vince and Becky, I get overwhelmed often with all the " cures" and then wonder what really holds up finding a cure.

Agreed. IMO it's politics at the research level (pet projects, etc...) with funding chasing the sexiest "cure de jour" (currently genetics)...

 

[lgelb]

Phase III this year? I doubt it. Looks like no data lock on the current US Phase II study till late spring, if then. To analyze/report that, design Phase III, get FDA approval, set up centers...next year, maybe. And their criteria to date understandably, given the procedure, specify the recently-dx'd (12-24 months of sx) to the extent of no tubes, BiPAP, etc. So not that many reading this now will be eligible, I'm sorry to say.

 

[hjlindley]

In my former life I was in FDA consultant. They are regulated by Congress and don't get to change the rules as they see fit. The disaster that happened in France is exactly what they worry about . One person died, and others have series neurological deficits . There is neither a biomarker for a good animal model for ALS. I think phase II will take about 24 months, but that's just my best guess. This is frustrating for all of us.

 

[kenschatz]

I have been following Brainstorm very closely. They are also publicly traded, there stock went down recently, so they sent out a lot of articles extolling the possible virtues. Stock went up, and now leveled off. i think they might be the best of the stem cell bunch, but in fact there have been no real positive results that I can find. They will be doing more trials soon, but I agree with lgelb.