Drug intelligence / Profile preview

autologous cultured keratinocytes

Development stage
Phase 3
Lead developer
Biosolution
Modality
Cell Therapies
Administration
Topical
01

Overview

Autologous cultured keratinocytes are a type of cell therapy used for the permanent coverage of severe, large-area burn wounds. The therapeutic process involves harvesting a small biopsy of the patient's own healthy skin, from which keratinocytes are isolated and expanded in vitro to produce either a cell suspension or sheets of cultured epithelium. These autologous cells are then grafted onto the patient's wound bed, where they promote rapid re-epithelialization and tissue regeneration while eliminating the risk of immune rejection. Key products in this category include Biosolution's **KeraHeal** (approved in South Korea) and Vericel's **Epicel** (marketed in the U.S. under a Humanitarian Device Exemption). This approach is particularly critical for patients with deep second- or third-degree burns covering more than 30% of the total body surface area, where donor site availability for traditional skin grafting is severely limited.

Brand names
KeraHealEpicel
Other names
autologous cultured keratinocyte cellCultured Epidermal AutograftCEA

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