Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)

Phase 3

Recruiting

• Conditions: Single Ventricle; Hypoplastic Left Heart Syndrome
• Interventions: Genetic: Autologous cardiac stem cells (JRM-001)

• Registration Number: NCT02781922
• Lead Sponsor: Metcela Inc.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-25
• Study Start: 2016-06
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-30
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

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

Inclusion Criteria

• Functional single ventricle patient with heart failure who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery
• EF(%) by echocardiography ≤ 55%
• Able to obtain written informed consent of participation in the study by a parent of the patient

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)
• Known history of hypersensitivity to anti-infective drugs
• Inability to complete the protocol treatment and baseline to follow-up examinations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous cardiac stem cells (JRM-001)	Autologous cardiac stem cells (JRM-001)	-

Primary Outcome Measures

Name	Time	Method
Change in ejection fraction (EF(%)) assessed by MRI from baseline	Baseline, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Change in EF(%) assessed by cardiac catheterization from baseline	Baseline, 6 and 12 months
Change in Ea/Ees assessed by cardiac catheterization from baseline	Baseline, 6 and 12 months
Change in EF(%) assessed by echocardiograms from baseline	Screening, Baseline, 3, 6 and 12 months
Change in heart failure index from baseline	Baseline, 3, 6 and 12 months
Change in Quality of Life (QOL) index from baseline	Baseline, 6 and 12 months
Number of adverse events	Up to 12 months
Change in Ventricular Stiffness assessed by cardiac catheterization from baseline	Baseline, 6 and 12 months

Trial Locations

Locations (3)

Kanagawa Children's Medical Center; 🇯🇵 Kanagawa, Japan

Okayama University Hospital; 🇯🇵 Okayama, Japan

Shizuoka Children's Hospital; 🇯🇵 Shizuoka, Japan