Date: 2014-08-06
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Mesoblast (Australia) National Heart, Lung and Blood Institute, NIH (USA)
Product: mesenchymal precursor cells (MPCs)
Action
mechanism: stem cell therapy
Disease: congestive heart failure, advanced heart failure
Therapeutic area: Cardiovascular diseases - Regenerative medicine
Country: USA
Trial
details: The 120-patient study, to be conducted by the NIH-funded Cardiothoracic Surgical Trials Network, will evaluate the effects of a single injection of 150 million allogeneic, or off-the-shelf, MPCs into the hearts of patients with advanced heart failure. The trial is a double-blind, placebo-controlled, 2:1 randomized design that is being conducted in more than 20 sites across the United States. The primary efficacy endpoint of the study is the number of temporary weans from LVAD tolerated over 12 months. Additionally, the study will evaluate patient survival and re-hospitalization over 12 months. The 150 million MPC dose selected for direct cardiac injection in this study is the same dose that is currently being evaluated in an ongoing Phase 3 trial of approximately 1,700 patients with NYHA Class II-III heart failure. The Phase 3 trial, sponsored by Mesoblast\'s development and commercial partner, Teva Pharmaceutical Industries, is actively enrolling patients across multiple sites in the United States.
Latest
news: * On August 6, 2014, Mesoblast announced the signing of an agreement with the United States National Institutes of Health\'s (NIH) National Heart, Lung and Blood Institute to collaborate on a trial using Mesoblast\'s proprietary adult stem cell therapy to treat patients with advanced heart failure requiring an implantable left ventricular assist device (LVAD) to maintain circulatory support. The National Institute of Neurological Disorders and Stroke, part of the NIH, and the Canadian Institutes for Health Research are also supporting this trial. The key objectives of using Mesoblast\'s Mesenchymal Precursor Cells (MPCs) in end-stage heart failure patients are to improve heart muscle function sufficiently to reduce the need for LVAD support, and to reduce the long-term complications of LVAD implantation which result in recurrent hospitalizations.
