Sept. 5, 2011
/PRNewswire/ -- Global regenerative medicine company, Mesoblast Limited, (ASX: MSB), today announced that it had received clearance from the European Medicines Agency (EMA) to begin a 225-patient multi-center Phase 2 clinical trial in
for its lead cardiovascular product Revascor(TM) in conjunction with angioplasty and stent procedures to prevent heart failure after a major heart attack. Revascor(TM) is an allogeneic, or "off-the-shelf", adult stem cell product derived from Mesoblast's proprietary Mesenchymal Precursor Cell (MPC) platform technology which is being developed for use in a range of cardiovascular diseases including congestive heart failure, chronic angina, and heart attacks (acute myocardial infarction).
The placebo-controlled Phase 2 trial, AMICI (Allogeneic Mesenchymal precursor cell Infusion in myoCardial Infarction), is approved under
's voluntary harmonization procedure and will initially recruit patients at multiple European sites, including in the
. Trial recruitment is subsequently expected to involve sites in additional European nations,
the United States
. The primary endpoint of the study will be safety and efficacy at six months in heart attack patients who will receive either Revascor(TM) at one of two doses or placebo. Durability of effect will additionally be monitored for up to 36 months.
Heart attacks remain the biggest killer of people in the industrialized world. Every year, over 1.7 million people have a heart attack in
, and over 1.1 million in
the United States
. Most of these patients undergo an early angioplasty of the blocked artery accompanied by implantation of a metal stent to keep the artery open long-term. However, a significant number of the surviving patients subsequently become disabled with heart failure.
Revascor(TM) is injected by a simple intracoronary infusion at the same time as the angioplasty and stent procedure, within 12 hours of the heart attack. In preclinical trials, a simple intracoronary infusion of Mesoblast's off-the-shelf MPCs increased the number of blood vessels in the infarcted region, prevented scar formation, and significantly improved heart muscle function after a heart attack, preventing heart failure.