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

Recruitingn/aAges any - anyAllMetcela Inc.
NCT07884318 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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".

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Okayama University Hospital
Okayama, Japan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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