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ARTICLE | Clinical News

Mesenchymal precursor cells: Phase III amended

January 18, 2016 8:00 AM UTC

Mesoblast amended a double-blind, placebo-controlled, international Phase III trial evaluating MPCs in chronic CHF patients to change the primary endpoint to recurrent heart failure-related major adverse cardiovascular events (HF-MACE). The previous primary endpoint was time to first HF-MACE. Due to the revised primary endpoint, FDA has agreed to a reduction in enrollment to 600 patients from 1,165, as previously planned. The trial is evaluating a single dose of 150 million MPCs delivered via transendocardial injection catheter to the left ventricle of the heart. Mesoblast said the partners now plan to conduct a second confirmatory study in parallel in an identical patient population of about 600 using the same primary endpoint. ...