Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)

Hypoplastic Left Heart Syndrome Clinical Trial

Official title: Phase 2 Study of Intracoronary Infusion of Cardiac Progenitor Cells in Patients With Univentricular Heart Disease

Status Completed

Clinical Trial Summary

The purpose of this study is to investigate the efficacy of intracoronary infusion of cardiac progenitor cells in patients with univentricular heart disease. Patients with preoperative high-risk group or whose cardiac function did not recover postoperatively eventually have no choice other than heart transplantation.

Clinical Trial Description

Following the safety verification of the Phase I study (TICAP trial) that has been implemented and completed, the efficacy will be verified in this Phase II clinical study. The rationale of this study is based on the animal studies that transplanted cardiac progenitor cells may regenerate damaged myocardium by giving rise to cardiac muscle and vascular cell types. Preclinical and phase I studies indicate the possibilities of cardiac function improvements and reduced myocardial fibrosis by progenitor cell infusion.

The efficacy of cell transplantation is assessed as the primary endpoint of the Phase II clinical study. The improvements of cardiac ejection fraction assessed by echocardiography, ventriculography, and cardiac MRI, which are conducted before and after treatment, are assessed as the evaluation items. The absolute values of the improvement of cardiac ejection fraction obtained by the above three imaging modalities before and after treatment are compared between two groups of the transplantation group and non-transplantation group. ;

Related Conditions & MeSH terms

• Heart Diseases
• Hypoplastic Left Heart Syndrome
• Single Left Ventricle
• Single Right Ventricle
• Univentricular Heart

• NCT number: NCT01829750
• Study type: Interventional
• Source: Okayama University
• Status: Completed
• Phase: Phase 2
• Start date: April 2013
• Completion date: September 2016