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โ† Trials
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Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)

RecruitingPhase 3Ages 0 Years - 6 YearsAllMetcela Inc.
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Functional single ventricle patient with heart failure who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery * EF(%) by echocardiography โ‰ค 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
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What it tests

  • Autologous cardiac stem cells (JRM-001)
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Where

4 sites
Kanagawa Children's Medical Center
Kanagawa, Japan
Okayama University Hospital
Okayama, Japan
Osaka Women's and Children's Hospital
Osaka, Japan
Shizuoka Children's Hospital
Shizuoka, Japan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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