Cell therapy in Chagas cardiomyopathy (Chagas arm of the multicenter randomized trial of cell therapy in...

Area of Science:

• Cardiology
• Regenerative Medicine
• Clinical Trials

Background:

• Previous studies suggested autologous bone marrow-derived mononuclear cells (BMNCs) may improve heart function in chronic chagasic cardiomyopathy.
• This is the first randomized trial investigating BMNC therapy for this condition.

Purpose of the Study:

• To evaluate the efficacy of intracoronary autologous BMNC injection in improving left ventricular function in patients with chronic chagasic cardiomyopathy.
• To assess the impact of BMNC therapy on quality of life and other clinical parameters.

Main Methods:

• A randomized trial involving 183 patients with chronic chagasic cardiomyopathy (NYHA class II-IV, LVEF <35%) treated with either intracoronary autologous BMNCs or placebo.
• The primary endpoint was the change in left ventricular ejection fraction (LVEF) at 6 and 12 months post-treatment.
• Intention-to-treat analysis was performed, powered to detect a 5% absolute difference in LVEF.

Main Results:

• No significant difference in LVEF change was observed between the BMNC group and the placebo group at 6 months (3.0% vs 2.5%) or 12 months (3.5% vs 3.7%).
• Secondary endpoints, including ventricular volumes, functional class, quality of life, and exercise capacity, also showed no significant differences between the groups.
• A median of 2.20x10^8 BMNCs were injected in the treatment arm.

Conclusions:

• Intracoronary injection of autologous BMNCs does not improve left ventricular function in patients with chronic chagasic cardiomyopathy.
• BMNC therapy did not lead to significant improvements in quality of life or other clinical parameters compared to placebo.