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

RECRUITINGPhase 3Sponsored by Metcela Inc.
Actively Recruiting
PhasePhase 3
SponsorMetcela Inc.
Started2016-06
Est. completion2028-12
Eligibility
Age0 Years – 6 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT02781922

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

Eligibility

Age: 0 Years – 6 YearsHealthy volunteers accepted
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

Conditions3

Heart DiseaseHypoplastic Left Heart SyndromeSingle-ventricle

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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