Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology (TICAP)

Okayama University

Status and phase: Completed; Phase 1

Conditions: Single Ventricle; Hypoplastic Left Heart Syndrome; Heart Failure

Treatments: Procedure: staged shunt procedure; Procedure: Autologous cardiac progenitor cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01273857

MHLW10103228

Details and patient eligibility

About

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.

Full description

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. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.

Enrollment: 14 patients

Sex: All

Ages: Under 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Control

Sham Comparator group

Description:

Subjects will undergo standard staged-procedures without cell infusion

Treatment:

Procedure: staged shunt procedure

Cell infusion

Experimental group

Description:

Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure

Treatment:

Procedure: Autologous cardiac progenitor cell transplantation

Procedure: staged shunt procedure