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Also known as Lomecel-B medicinal signaling cells
Lomecel-B · 1 trial · 1 indication
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...