Transcoronary cell infusion with the stop-flow technique in children with single-ventricle physiology

Area of Science:

• Pediatric Cardiology
• Regenerative Medicine
• Cell Therapy

Background:

• Cardiac regeneration therapy research predominantly focuses on adults.
• Limited studies explore transcoronary infusion of cardiac progenitor cells in pediatric patients.
• The stop-flow technique offers a novel approach for pediatric cardiac interventions.

Purpose of the Study:

• To evaluate the safety and feasibility of transcoronary infusion of cardiosphere-derived cells (CDC) in children with single-ventricle physiology.
• To assess the efficacy of this novel cardiac regeneration therapy in a pediatric population.
• To report findings from Phase 1 and Phase 2 clinical trials.

Main Methods:

• Intracoronary autologous CDC transfer was performed using the stop-flow technique.
• Phase 1 trial included 7 patients with hypoplastic left heart syndrome.
• Phase 2 trial involved 34 patients with single-ventricle physiology.
• A total of 41 pediatric patients underwent the procedure.

Main Results:

• Transcoronary infusion of CDC was successfully completed in all 41 patients.
• Transient adverse events (e.g., ECG changes, hypotension) were observed but resolved completely.
• No major procedure-related adverse events occurred, indicating a favorable safety profile.
• The median age was 33 months and median weight was 10.1 kg.

Conclusions:

• Transcoronary infusion of CDC using the stop-flow technique is a feasible and safe procedure in children.
• This method represents a promising advancement in pediatric cardiac regeneration.
• The study supports the continued investigation of CDC therapy for congenital heart defects in children.