GVHD in US, page-17

Do you have a problem with the current cell production methods?

It seems the first of the LVAD trials was initially described as a Phase 2, NCT01442129, for what would be a new indication.  The resulting paper is available online, Mesenchymal Precursor Cells as Adjunctive Therapy in Recipients of Contemporary Left Ventricular Assist Devices

An effect was noticed in the (now) 2a trial and the recent 2b trial on GI bleeding that may be enough to launch a new treatment without need to go through a Phase 3 trial, perhaps a confirmatory or Phase 4 trial post release or other data collection method will suffice, subject to FDA examination of the full 2b trial results. 

The interesting thing is that the indication that Revascor might be used for in relation to LVAD use was not the indication the researchers were testing for as their primary endpoints. The research was not funded by Mesoblast.