Mesoblast Limited (ASX: MSB) had received clearance to begin trial of a drug that it says can improve the quality of life for patients suffering acute heart attacks.

The European Medicines Agency has given the global regenerative medicine company the green light to begin a 225 patient trial in Europe for Revascor, an allogeneic or “off-the-shelf” adult stem cell product being developed for use in a range of cardiovascular diseases including congestive heart failure, chronic angina, and heart attacks.

The placebo-controlled Phase 2 trial is approved under Europe's voluntary harmonization procedure and will initially recruit patients at multiple European sites, including in the United Kingdom, The Netherlands and Belgium. Trial recruitment is subsequently expected to involve sites in additional European nations, Australia, and the United States.

Lead investigator Dr Jonathan Hill 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.

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.