Drug intelligence / Profile preview

SkinTE

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

Overview

SkinTE is an autologous cellular regenerative medicine product designed to regenerate full-thickness, functional skin for the treatment of chronic wounds and reconstructive surgery. Developed by PolarityTE (and later acquired by Grander Acquisition), the product is manufactured using a small sample of the patient's own healthy skin, which is processed into 'skin polar units.' These units contain the necessary cellular components and tissue architecture to facilitate vascularized epithelial regeneration across the wound bed. SkinTE has received the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and is primarily being evaluated in Phase III clinical trials for diabetic foot ulcers (DFUs) and other chronic cutaneous ulcers.

Brand names
SkinTE
Other names
human autologous homologous skin constructautologous skin construct

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