Bicomponent Cutaneous Cell Therapy for Early Burn Care: Manufacturing Homogeneity and Epidermis-Structuring Functions of Clinical Grade FE002-SK2 Allogeneic Dermal Progenitor Fibroblasts.

Early human evidence such as case series or small samples is exploring possible benefits.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Background: The extracellular matrix (ECM), primarily composed of collagen and elastin synthesized by dermal fibroblasts, is critical for mesenchymal tissue integrity. Fibroblast phenotypes vary significantly with the anatomical location and developmental stage. Fetal skin, particularly prior to 14 weeks of gestation, exhibits a simplified structure compared to adult skin, characterized by a thin, loose dermal matrix and a single-layered epithelium. Objectives: This study aimed to characterize and functionally compare homogenous progenitor fetal fibroblast (PFF) populations derived from 14-week-old fetal skin with fibroblasts isolated from adult burn patients. Methods: We evaluated the proliferative capacity, collagen synthesis, and differentiation potential (adipogenesis and osteogenesis) of PFF and adult burn patient fibroblasts. Furthermore, we assessed their ability to support skin regeneration using a de-epidermized dermis (DED) model seeded with both PFF and patient-derived keratinocytes. The stability of PFF characteristics was monitored across multiple passages (P5-P12). Results: PFF demonstrated a 2-4-fold increase in proliferation rate and a 30-50% enhancement in collagen production in vitro compared to adult fibroblasts. Notably, PFF exhibited a consistent lack of adipogenic and osteogenic differentiation, an attribute distinct from adult fibroblasts. In the DED mode

Evidence level

Early human evidence such as case series or small samples is exploring possible benefits.

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