Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04925024 | Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial. | PHASE2 | ACTIVE NOT_RECRUITING | 40 | — | — | Jun 25, 2021 | Aug 31, 2026 | Jun 25, 2025 | 10 | United States |
Efficacy will be reported as change in right ventricular ejection fraction (RVEF) assessed as a percentage and will be measured via cardiac magnetic resonance (CMR) imaging.
| Arm | Type | Description |
|---|---|---|
| Lomecel B Group | EXPERIMENTAL | Participants randomized to receive Lomecel-B injections during their Stage II palliation. |
| No Study Intervention Control Group | NO_INTERVENTION | Participants randomized to receive no study intervention during their Stage II palliation. |
| Name | Type | Description |
|---|---|---|
| Lomecel-B medicinal signaling cells | BIOLOGICAL | A single administration of Lomecel-B will be performed via 6-10 intramyocardial injections into the right ventricle during the participant's standard of care stage II palliation. Dosing is based on body weight. Each patient will be given 2.5 x 10\^5 cells per kg of body weight. The entire dose of the cells will be roughly 600 microliters. |
Inclusion: All participants must have HLHS (includes all types) requiring Stage II palliation (Glenn or Hemi-Fontan operation). Exclusion: 1. Requirement for ongoing mechanical circulatory support immediately prior to Stage II palliation within 5 days 2. Need for concomitant surgery for aortic co...