Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
Recruiting
Phase 3
Interventional Study
Hypoplastic Left Heart Syndrome
Single Ventricle
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 0 – 6
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- Metcela Inc. · Industry
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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
Trial Locations
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Eligibility Criteria
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:
* …
Contacts