Mesenchymal precursor cell treatment (Mesoblast) enters Phase III Heart Failure study
Mesoblast's stem cell derived mesenchymal precursor cell treatment is moving into Phase III for Heart Failure patients, now the FDA has cleared the company's Investigational New Drug filing. The multi-center trial, which will be conducted by Teva, is planned to enrol approximately 1,700 patients and includes two interim analyses of efficacy and/or safety.
The clinical protocol was designed after initial consultation with both the FDA and the European Medicines Agency. The study is a double-blinded, 1:1 randomized, placebo-controlled study evaluating a single dose of 150 million MPCs delivered via transendocardial injection catheter to the left ventricle of Heart Failure patients.
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