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

Phase 3

Recruiting

• Conditions: Functional single ventricle

• Registration Number: JPRN-jRCT1080223307
• Lead Sponsor: Metcela Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: recruiting
• Sex: All
• Target Recruitment: 40

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified