Phase 2 Study of Intracoronary Infusion of Cardiac Progenitor Cells in Patients With Univentricular Heart Disease
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hypoplastic Left Heart Syndrome
- Sponsor
- Okayama University
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Cardiac function
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Hidemasa Oh, MD
Professor
Okayama University
Eligibility Criteria
Inclusion Criteria
- •Age: Age is 0 year or more and 20 years or less at the time of enrollment.
- •The patients have functional single ventricular physiology with the indication to have stage-2 or -3 palliative surgeries.
- •The ventricular ejection fraction \<60%.
Exclusion Criteria
- •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 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
Outcomes
Primary Outcomes
Cardiac function
Time Frame: 3 Months
The primary outcome measure is to evaluate the cardiac function improvement by echocardiography, ventriculography, and cardiac MRI, which are conducted before and 3 months after surgical treatment.
Secondary Outcomes
- Cardiac function(12 Months)