Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
Japan40 participantsStarted 2016-06
Plain-language 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
Who can participate
Age range0 Years – 6 Years
SexALL
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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
What they're measuring
1
Change in ejection fraction (EF(%)) assessed by MRI from baseline
Timeframe: Baseline, 6 and 12 months
Trial details
NCT IDNCT02781922
SponsorMetcela Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-12
Contact for this trial
Metcela Inc. (former Japan Regenerative Medicine Co., Ltd.)