NIH and Mesoblast enter into agreement for 120-patient end-stage heart failure trial
The NIH and Mesoblast trial aims to analyze the use of single intracardiac injections of allogeneic MPCs in reducing need for LVAD support and recurrent hospitalizations.
Regenerative medicine company Mesoblast Ltd have signed an agreement with the National Heart, Lung and Blood Institute (NHLBI) of the NIH to collaborate on a trial using Mesoblast's proprietary adult stem cell therapy, mesenchymal precursor cells (MPCs), to treat patients with advanced heart failure requiring an implantable left ventricular assist device (LVAD) to maintain circulatory support.
The Cardiothoracic Surgical Trials Network will evaluate the effects of a single intracardiac injection of 150 million allogeneic MPCs in 120 patients with advanced heart failure in a double-blind, placebo-controlled, 2:1 randomized design that is being conducted in more than 20 sites across the USA. The primary efficacy end point is the number of temporary weans from LVAD tolerated over 12 months (i.e., improved heart muscle function enough to reduce the need for LVAD support) and secondary end points are improved patient survival and reduced re-hospitalization over 12 months.
This study hopes to build upon results published in Circulation in June showing potential benefits of a single intracardiac injection of 25 million Mesoblast MPCs in 30 advanced heart failure and LVAD implantation patients.
The trial is also supported by the National Institute of Neurological Disorders and Stroke (NINDS), also part of the NIH, and the Canadian Institutes for Health Research.
Find the full press release and June Circulation article here