dm+d

Unassigned

New Medicines

Prevention of heart failure after myocardial infarction - with angioplasty and stent procedures

Information

New molecular entity
Mesoblast
Mesoblast

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
None

Category

An allogeneic autologous mesenchymal precursor cell (MPC) product. MPCs release factors that may induce functional cardiac recovery by simultaneously regenerating the endogenous vascular network as well as endogenous cardiomyocytes or cardiomyocyte precursors. Preclinical studies have shown that, when injected into ischemic myocardium, MPCs are potent inducers of large caliber arteriogenesis.
Over 200,000 hospital visits each year are due to myocardial infarction. In 2014, the UK Clinical Practice Research Datalink GOLD database produced data suggesting that the prevalence of myocardial infarction was 2.46% in men of all ages, and 0.87% in women of all ages [1].
Prevention of heart failure after myocardial infarction - with angioplasty and stent procedures
Intracoronary

Trial or other data

Apr 21PII AMICI trial completes [2].
Mar 13PII AMICI trial of MPC 25 IC in conjunction with angioplasty and stent procedures, for the prevention of heart failure following myocardial infarction starts (NCT01781390). 106 adults with de novo anterior myocardial infarction will be recruited in the UK (at Newcastle upon Tyne Hospital), in Europe, Australia and New Zealand. The primary endpoint is safety and efficacy at 6 months post-infarction and the duration of effect will be monitored for 36 months. Patients will receive placebo or one of two doses of MPCs - MPC 12.5 solution 2 mL/min infused intravenously for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0 or Participants received MPC 12.5 solution 2 mL/min infused intravenously for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0 [2].