Texas Heart Institute

This cell delivery strategy championed by lead investigator, Dr. Emerson C. Perin, MD, PhD, Director, Research in Cardiovascular Medicine and Medical Director of the Stem Cell Center at Texas Heart Institute, Clinical Professor of Medicine at Baylor College of Medicine and McNair Scholar, offers a promising alternative to patients with advanced heart failure because of MPCs ability to induce heart muscle repair, stimulate new blood vessel growth, decrease cell death and reduce scar formation.

Lead author and investigator Dr. Emerson C. Perin said, “The findings from this trial are very encouraging and suggest that a high-dose of Mesoblast’s allogeneic cell-based therapy may decrease major clinical events associated with progressive heart failure for at least three years, including repeated hospitalizations or death. This has the potential to be transformative for those with the most severe coronary heart disease and heart failure.”

Key results of the trial were:
Primary Endpoint of Safety
• Transendocardial injections of allogeneic MPCs into the hearts of patients with either ischemic or non-ischemic heart failure due to left ventricular systolic dysfunction were feasible and safe, with a similar incidence of adverse events across all control and treatment groups.
• Treatment of patients with allogeneic MPCs was not associated with any clinically significant immune response.

Secondary Efficacy Endpoints
• Patients treated with the highest dose, MPC 150M, showed the greatest improvement compared to controls for left ventricular remodelling (Left Ventricular End Systolic Volume (LVESV) p=0.015 and Left Ventricular End Diastolic Volume (LVEDV) p=0.02) at month 6 post treatment.
• Parallel improvements in both LVESV and LVEDV in the MPC-treated groups may have accounted for the observed non-significant changes in ejection fraction.
• Patients treated with the highest dose, MPC 150M, showed the greatest improvement in functional exercise capacity compared to controls (6MTW: p=0.062) at month 12 post treatment.

Texas Heart Stem Cell Center is a world leader in clinical cardiovascular stem cell research. Although investigating all aspects of cardiovascular disease, the center has particular leadership in advancing treatments for heart failure, having performed the first human stem cell treatment for heart failure in December 2001. Since 2001, Texas Heart Stem Cell Center has led 7 randomized controlled trials (nationally and internationally) of stem cell therapy for heart failure, gradually gaining critical understanding of cell therapy and exploring different cell types. The stem cell center is currently involved in 4 randomized cell therapy trials for heart failure.