Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology
Condition: Hypoplastic Left Heart Syndrome; Single Ventricle; Heart Failure
MeSH terms: Univentricular Heart; Hypoplastic Left Heart Syndrome
Intervention: Autologous cardiac progenitor cell transplantation; staged shunt procedure
Intervention description: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.; Norwood-Glenn, Glenn, or Fontan procedure will be applied
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Cardiac progenitor cells; Cell therapy; Hypoplastic Left Heart Syndrome; Single Ventricle; Norwood; Sano modification; Glenn; Fontan

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