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Clinical Trials in Japan / NCT07884318
Recruiting Observational

Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease

NCT07884318 · tracked via the Priya Life Science Japan tracker
Sponsor
Metcela Inc
Phase
Observational
Started
2026-09-01
Last updated
2026-10-20

Condition(s) studied

Single VentricleHypoplastic Left Heart Syndrome (HLHS)

Study summary

The objective of this observational study is to investigate the long-term safety of autologous cardiac stem cells (JRM-001) administered to patients with single ventricle physiology. This study will conduct a one-year safety follow-up of participants in "Efficacy and safety study of autologous cardiac stem cells (JRM-001) treated after reconstructive surgery in pediatric patients with congenital heart disease".

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients who participated in "Efficacy and safety study of autologous cardiac stem cells (JRM-001) treated after reconstructive surgery in pediatric patients with congenital heart disease" and meet the following criteria; * JRM-001 administration group: received JRM-001 investigational product after catheter examination * Non-administered group: underwent cardiac catheter examiniation only Exclusion Criteria: * Patients who is difficult to visit the clinical trial site * Patients who is difficult to obtain the provision of medical information from clinical institute to which the patient is transferred

Primary outcome measure(s)

  • Adverse events or serious adverse events (SAE) — From enrollment to the end of treatment at 12 months
    Any adverse events or serious adverse events (SAE) occurred till months 12 of this study (corresponding to 24 months after JRM-001 administration)

Trial sites (1)

FacilityCityRegionStatus
Okayama University Hospital Okayama Okayama-ken Recruiting

More Metcela Inc. trials in Japan

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

Other trials for the same condition

Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07884318 on ClinicalTrials.gov ↗ ← All trials in Japan