Transcoronary Infusion of Cardiac Progenitor Cells in Patients with Single Ventricle Physiology (TICAP)
Phase 1
- Conditions
- Children with hypoplastic left heart syndrome or related single ventricle physiology
- Registration Number
- JPRN-UMIN000004823
- Lead Sponsor
- Center for Innovative Clinical Medicine, Okayama University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
Not provided
Exclusion Criteria
Exclusion criteia are the presence of cardiogenic shock, Eisenmenger syndrome, uncontrollable arrhythmia, severe chronic diseases, infections, cancer, or unwillingness to participate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Monitoring major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, new myocardial infarction, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards.
- Secondary Outcome Measures
Name Time Method Monitoring the rate of composite serious adverse events with death excluded and the rate of other complication.