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Lomecel-B medicinal signaling cells · 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 medicinal signaling cells is an investigational cell therapy being studied for Hypoplastic Left Heart Syndrome (HLHS), a severe congenital heart defect. It is currently in Phase 2 clinical development and has not been approved by the FDA. The therapy is being evaluated in a randomized, double-blind, placebo-controlled trial.
Lomecel-B medicinal signaling cells is a cell therapy being developed by Longeveron Inc. (NASDAQ: LGVN). It is designed to deliver medicinal signaling cells that may help repair or regenerate damaged heart tissue in patients with Hypoplastic Left Heart Syndrome. The exact mechanism of action is not fully detailed in the available information.
Lomecel-B medicinal signaling cells is being developed by Longeveron Inc., a clinical-stage biotechnology company traded on NASDAQ under the ticker symbol LGVN. The company is conducting a Phase 2 clinical trial to evaluate the therapy in patients with Hypoplastic Left Heart Syndrome.
Lomecel-B medicinal signaling cells is in Phase 2 clinical development. It is currently being studied in a Phase IIb trial for Hypoplastic Left Heart Syndrome. The therapy has received Fast Track, Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Rare Pediatric Disease designations from the FDA, but it is not yet approved.
Lomecel-B is being evaluated in a Phase IIb clinical trial with the identifier NCT04925024. This randomized, double-blind, placebo-controlled study is enrolling 40 patients with Hypoplastic Left Heart Syndrome in the United States. The trial is currently active but not recruiting participants.
Yes, Lomecel-B medicinal signaling cells is the same as Lomecel-B. The full name includes the descriptive term 'medicinal signaling cells' to characterize the cell therapy. It is being developed by Longeveron Inc. for the treatment of Hypoplastic Left Heart Syndrome.