Efficacy and Safety Study of Autologous Cardiac Stem Cells (JRM- 001) Treated After Reconstructive Surgery in Pediatric Patients With Congenital Heart Disease

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080223307

Enrollment

Registered

2016-08-30

Start date

2016-08-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional single ventricle

Interventions

investigational material(s) Generic name etc : JRM-001 INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : 3x 10^5 cells/k

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Main inclusion criteria: - Functional single ventricle patient who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery - Ejection fraction (%) by echocardiography =< 55%

Exclusion criteria

Exclusion criteria: Main exclusion criteria: - Known medical history of cardiogenic shock - Lethal, uncontrollable arrhythmia - Complication of coronary artery disease - Eisenmenger syndrome - Complication of brain dysfunction due to circulatory failure - Malignant neoplasm - Complication of severe neurologic disorder - Severe pulmonary embolism or pulmonary hypertension - Severe renal failure - Multiple organ failure - Active infection (including endocarditis) - Sepsis - Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury)

Design outcomes

Primary

Measure	Time frame
Ejection fraction assessed by cardiac MRI	—

Secondary

Measure	Time frame
Cardiac function assessed by echocardiograms and cardiac catheterization, heart failure index, QOL index, adverse events, ECG, clinical laboratory assessments etc.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026