Children with hypoplastic left heart syndrome or related single ventricle physiology
Conditions
Interventions
The study patients will be involving 7 treated and 7 control subjects. Autologous cardiac progenitor cells are isolated from patients'
own cardiac tissues obtained during palliative shunt procedure. Patients will receive 0.3 million/kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Fo
Sponsors
Center for Innovative Clinical Medicine, Okayama University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants with single ventricle physiology undergoing second to third palliative shunt surgeries will be recruited into the study. Patients between 0 and 6 years of age are eligible if written informed consent can be obtained.
Exclusion criteria
Exclusion criteria: Exclusion criteia are the presence of cardiogenic shock, Eisenmenger syndrome, uncontrollable arrhythmia, severe chronic diseases, infections, cancer, or unwillingness to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Monitoring the rate of composite serious adverse events with death excluded and the rate of other complication. | — |
Countries
Japan
Contacts
Public ContactRie Yokoyama
Okayama University Hospital Department of Cardiovascular Surgery
Outcome results
None listed