The European Medicines Agency (EMA) has given clearance to Mesoblast to begin a 225-patient multicentre phase II clinical trial in Europe for its lead cardiovascular product Revascor in conjunction with angioplasty and stent procedures to prevent heart failure after a major heart attack.
Revascor 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 acute myocardial infarction.
The placebo-controlled phase II trial, AMICI (Allogeneic mesenchymal precursor cell Infusion in myocardial infarction), is approved under Europe’s voluntary harmonisation procedure and will initially recruit patients at multiple European sites, including the United Kingdom, The Netherlands and Belgium. Trial recruitment is subsequently expected to involve sites in additional European nations, Australia, and 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 at one of two doses or placebo. Durability of effect will additionally be monitored for up to 36 months.
Revascor 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.
“The preclinical data were very compelling, and formed the basis for this innovative clinical trial,” said the study’s principal investigator, professor Eric Duckers, interventional cardiologist, head of molecular cardiology and associate professor, Thoraxcenter, Erasmus University Hospital in The Netherlands.
“We are excited to be pioneering a novel and minimally invasive clinical approach that has the potential to greatly improve the quality of life for patients suffering acute heart attacks,” Duckers added.
Jonathan Hill, UK’s lead investigator, consultant interventional cardiologist at King’s College Hospital and King’s Health Partners Academic Health Sciences Centre, said: “This stem cell product has the potential to change the medical paradigm for treatment of large heart attacks, and to provide for the first time a validated and effective off-the-shelf therapy for routine use.”