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Also known as Lomecel-B medicinal signaling cells, Longeveron Mesenchymal Stem Cells (LMSCs)
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...
Lomecel-B is an investigational cell therapy being developed by Longeveron Inc. (ticker LGVN). It is in Phase 2 clinical development for hypoplastic left heart syndrome, a rare congenital heart defect. It is not approved for commercial use and remains under clinical study.
Lomecel-B is being studied as a treatment for hypoplastic left heart syndrome (HLHS), a severe congenital heart condition in which the left side of the heart is underdeveloped. The investigational therapy is intended for pediatric patients with this condition and is not yet approved for any use.
Lomecel-B is developed by Longeveron Inc., a biotechnology company that trades under the ticker symbol LGVN. Longeveron is the sponsor of the clinical program evaluating the cell therapy in hypoplastic left heart syndrome.
Lomecel-B is in Phase 2 clinical development. The ongoing trial is a Phase 2b study in hypoplastic left heart syndrome. The therapy is investigational and has not received FDA approval for any indication.
Lomecel-B is being evaluated in the Phase 2b trial NCT04925024, titled Evaluation of Lomecel-B Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS). The trial is active but not recruiting, is randomized and double-blind with a no-treatment control, and has an enrollment of 40 patients in the United States.
Lomecel-B has received three FDA designations for hypoplastic left heart syndrome: Orphan Drug, Fast Track, and Rare Pediatric Disease. These designations support the development program, but the therapy remains investigational and has not been approved by the FDA.
Yes. Lomecel-B is also referred to as Lomecel-B medicinal signaling cells. Both names describe the same investigational cell therapy developed by Longeveron Inc. for hypoplastic left heart syndrome, and they appear interchangeably in references to the clinical program.