Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-6
SponsorMetcela Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Known medical history of cardiogenic shock
Lethal, uncontrollable arrhythmia
Complication of coronary artery disease
Eisenmenger syndrome
Trial design
Design model
Parallel
Treatments tested in this trial
Autologous cardiac stem cells (JRM-001)
Genetic3x 10\^5 cells/kg, single treatment
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Autologous cardiac stem cells (JRM-001)Experimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in ejection fraction (EF(%)) assessed by MRI from baseline
Time frame
Baseline, 6 and 12 monthsSecondary outcomes
1
Change in EF(%) assessed by echocardiograms from baseline
Time frame
Screening, Baseline, 3, 6 and 12 months2
Change in EF(%) assessed by cardiac catheterization from baseline
Time frame
Baseline, 6 and 12 months3
Change in Ea/Ees assessed by cardiac catheterization from baseline
Time frame
Baseline, 6 and 12 months4
Change in Ventricular Stiffness assessed by cardiac catheterization from baseline
Time frame
Baseline, 6 and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov