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
Qualifiers
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
Treatments tested in this trial
- Autologous cardiac stem cells (JRM-001)
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov