Cell Therapy News/Articles, page-13476

Well....

The phase 2 took 3 years with 60 patients ( min 12 month follow up )

The phase 3 took 6 years, started recruiting 2014 and finished recruiting Jan 2019, The primary end point changed which moved the trial end forwards. ( Min 12 month follow up ) and they looked at over 1000 patients to randomize 537
However..... the results if you happen to be class 2 and inflamed, were outstanding.

Based on that, I would expect the next trial to target those with greatest benefit, and knowing the potential benefit there should be a lot more people willing to go maximal care plus the cells.

I'm assuming they use mortality as the primary end point given they already know they can achieve it, so unfortunately with only class 2 patients that is going to take a while.

They could use a surrogate end point ( CRP levels ) possibly instead of waiting for the class 2 to degenerate, but it takes time and I think the company simply have to proove here beyond a shadow of a doubt the cells reduce mortality by repeating the results al be it in a selected group

My guess would be at least 3 years, but I have absolutely no idea how many patients they will need to treat to power it enough

"Greatest benefit in patients with elevated CRP at baseline with reduction in 3-Point MACE of 54% "