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6-K
MESOBLAST LTD filed this Form 6-K on 08/31/2018
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Slide 22

MPC-150-IM: End-stage heart failure clinical strategy 159-patient, double-blind, placebo-controlled 2:1 randomized Phase 2b trial, evaluating safety and efficacy of a single injection of MPC-150-IM into the native myocardium of LVAD recipients Study funded by the US National Institutes of Health (NIH) and Canadian Health of Research Institute, and conducted by the NIH-funded Cardiothoracic Surgical Trials Network (CTSN) Study Endpoints: Safety, including GI bleeding Number of temporary weans from LVAD tolerated through 6 months Time to re-hospitalization (through 12 months) Patient survival (through 12 months) Enrollment completed in Q3 CY2017 12 month database lock in Q3 CY2018 Full trial results to be presented at upcoming major cardiovascular conference Mesoblast is in active discussions with the FDA on the regulatory pathway under the Regenerative Medicine Advanced Therapies (RMAT) designation granted in December 2017


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