pp-197 Solution for infusion
Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Hypoplastic left heart syndrome (HLHS) — cardiac regenerative therapy in paediatric patients post-Norwood procedure
Clinical stage: Phase 2b
Modality: Biological (allogeneic mesenchymal stem/stromal cell therapy — off-the-shelf)
Mechanism / Target: Allogeneic human cardiac-derived mesenchymal stem cells (Lomecel-B); promotes cardiac regeneration, angiogenesis, and anti-inflammatory remodelling via paracrine cytokine and exosome signalling; improves ventricular function and reduces vascular resistance
Route / form: IV infusion (intracoronary or IV)
Differentiation: Only cell therapy in active clinical development for HLHS;
Manufacturer #39336
US-based clinical-stage regenerative medicine company developing Rx allogeneic cell-based therapies for aging-related and other serious conditions. Lead biologic is advancing through multiple mid-stage clinical studies. Listed on a US exchange.
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