Phase 1
N=14
Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology
Hypoplastic Left Heart Syndrome · Single Ventricle · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01273857 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Feasibility Evaluation and Major Cardiac Adverse Events Related to Transcoronary Infusion of Cardiac Progenitor Cells — 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Autologous cardiac progenitor cell transplantation (Procedure); staged shunt procedure (Procedure)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Okayama University
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility Evaluation and Major Cardiac Adverse Events Related to Transcoronary Infusion of Cardiac Progenitor Cells |
0; 0 | — |
| SECONDARY Serious Adverse Events |
0; 0 | — |
Summary
Hypoplastic left heart syndrome (HLHS) and related anomalies involved a single ventricle are characterized by hypoplasia of the left heart and the aorta with compromised systemic cardiac output. Infants with the syndrome generally undergo a staged surgical approach in view of an ultimate Fontan procedure. Although long-term survival in patients with HLHS and related single ventricle physiology has improved markedly with advances in medical and surgical therapies, a growing number of infants will ultimately require heart transplantation for end-stage heart failure due to several potential disadvantages include a negative effect on right ventricular function, arrhythmia, additional volume load via regurgitation from the nonvalved shunt, and impaired growth of the pulmonary artery.
Risk factors for poor outcome of heart transplantation with HLHS and single ventricle physiology are older age at transplantation and previous Fontan operation. New strategies are needed to improve the underlying transplant risks proper for the Fontan failure patients.
Emerging evidence suggests that heart-derived stem/progenitor cells can be used to improved cardiac function in patients with ischemic heart disease. In this trial, the investigators aimed to test the safety and feasibility of intracoronary injection of autologous cardiac progenitor cells in patients with HLHS and related single ventricle anomalies and that could improve ventricular function at 3 months' follow up.
Eligibility Criteria
Inclusion Criteria
- Infants with hypoplastic left heart syndrome and related single ventricle anomalies undergoing first 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
- Cardiogenic shock
- Eisenmenger syndrome
- Uncontrollable arrhythmia
- Severe chronic diseases
- Infections
- Cancer
- Unwillingness to participate
Data sourced from ClinicalTrials.gov (NCT01273857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.