Agree; is this the details of the phase 2 trial https://clinicaltrials.gov/show/NCT00721045? in particular
Primary Outcome Measures:
- The primary objective of this study is to evaluate the feasibility and safety of transendocardial injection using mapping Catheter with the Left Ventricular Injection Catheter of 25 M, 75 M, and 150 M allogeneic MPCs in subjects with heart failure. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
I don't see any mention of the end points highlighted earlier and included again below in relation to any trial linked to Mesoblast,
- The secondary objectives are to explore functional efficacy for subsequent study design. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
NYHA class
LVEF
6 minute walk
myocardial perfusion
BNP
So if they - the end points - weren't included in MSB's trial then I don't see how they could then have been missed. If there is something I have missed here (a different trial perhaps) then please advise. There was this trial https://clinicaltrials.gov/ct2/show/NCT00555828 but I thought it was a non starter due to recruitment issues. As it stands, I believe Phase 2 went ok.
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