Overview

This trial is active, not recruiting.

Conditions hypoplastic left heart syndrome, single right ventricle, single left ventricle
Treatment cardiac progenitor cell infusion
Phase phase 2
Sponsor Okayama University
Collaborator Translational Research Informatics Center, Kobe, Hyogo, Japan
Start date April 2013
End date March 2018
Trial size 34 participants
Trial identifier NCT01829750, 0329-18, MHLW25040101

Summary

The purpose of this study is to investigate the efficacy of intracoronary infusion of cardiac progenitor cells in patients with univentricular heart disease. Patients with preoperative high-risk group or whose cardiac function did not recover postoperatively eventually have no choice other than heart transplantation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Sham Comparator)
(Stage 1) No active intervention after standard surgical treatment (Stage 2) Rescuing transplantation by cardiac progenitor cell infusion is applicable in patients, along with their written consent, 4 months after palliations who were assigned as control group in stage 1.
cardiac progenitor cell infusion
(Stage 1) Cardiac progenitor cell infusion in patients who assigned as active comparator group (Stage 2) Rescuing transplantation is applicable in patients, along with their written consent, 4 months after palliations who were allocated as control group in stage 1.
(Active Comparator)
(Stage 1) single dose, intracoronary infusion of 0.3 million cells/kg cardiac progenitor cells
cardiac progenitor cell infusion
(Stage 1) Cardiac progenitor cell infusion in patients who assigned as active comparator group (Stage 2) Rescuing transplantation is applicable in patients, along with their written consent, 4 months after palliations who were allocated as control group in stage 1.

Primary Outcomes

Measure
Cardiac function
time frame: 3 Months

Secondary Outcomes

Measure
Cardiac function
time frame: 12 Months

Eligibility Criteria

Male or female participants up to 20 years old.

Inclusion Criteria: 1. Age: Age is 0 year or more and 20 years or less at the time of enrollment. 2. The patients have functional single ventricular physiology with the indication to have stage-2 or -3 palliative surgeries. 3. The ventricular ejection fraction <60%. Exclusion Criteria: 1. Cardiogenic shock 2. A patient with unstoppable extracorporeal circulation 3. A patient with lethal, uncontrollable arrhythmia 4. A patient with a complication of coronary artery disease 5. A patient with a complication of brain dysfunction due to circulatory failure 6. A patient with malignant neoplasm 7. A patient with a complication of serious neurologic disorder 8. A patient with high-grade pulmonary embolism or pulmonary hypertension 9. A patient with high-grade renal failure 10. A patient with multiple organ failure 11. Active infection (including endocarditis) 12. Sepsis 13. Active hemorrhagic disease (e. g. gastrointestinal bleeding, injury)

Additional Information

Official title Phase 2 Study of Intracoronary Infusion of Cardiac Progenitor Cells in Patients With Univentricular Heart Disease
Principal investigator Hidemasa Oh, M.D., Ph.D.
Description Following the safety verification of the Phase I study (TICAP trial) that has been implemented and completed, the efficacy will be verified in this Phase II clinical study. The rationale of this study is based on the animal studies that transplanted cardiac progenitor cells may regenerate damaged myocardium by giving rise to cardiac muscle and vascular cell types. Preclinical and phase I studies indicate the possibilities of cardiac function improvements and reduced myocardial fibrosis by progenitor cell infusion. The efficacy of cell transplantation is assessed as the primary endpoint of the Phase II clinical study. The improvements of cardiac ejection fraction assessed by echocardiography, ventriculography, and cardiac MRI, which are conducted before and after treatment, are assessed as the evaluation items. The absolute values of the improvement of cardiac ejection fraction obtained by the above three imaging modalities before and after treatment are compared between two groups of the transplantation group and non-transplantation group.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Okayama University.