Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy

A Prospective Phase 1 Trial of Cardiac Progenitor Cell Therapy in Children With Dilated Cardiomyopathy

A phase 1 prospective study to determine the procedural feasibility and safety and preliminary efficacy of intracoronary infusion of cardiosphere-derived cells (CDCs) in patients with dilated cardiomyopathy.

Five consecutive patients will be enrolled to a phase 1 study to verify the procedural feasibility and safety with the CDC infusion group.

Inclusion Criteria:

• Patients diagnosed as dilated cardiomyopathy.
• Patients aged under 18 years old.
• Cardiac ejection fraction < 40%.

Exclusion Criteria:

• Contradiction to cardiac magnetic resonance imaging.
• Cardiogenic shock.
• A patient with unstoppable extracorporeal circulation.
• A patient with lethal, uncontrollable arrhythmia.
• A patient with a complication of coronary artery disease.
• A patient with a complication of brain dysfunction due to circulatory failure.
• A patient with malignant neoplasm.
• A patient with a complication of a serious neurologic disorder.
• A patient with high-grade pulmonary embolism or pulmonary hypertension.
• A patient with high-grade renal failure.
• A patient with multiple organ failure.
• Active infection (including endocarditis).
• Sepsis.
• Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury).