Drug intelligence / Profile preview

MyOwn Skin

Development stage
Preclinical
Lead developer
BioLab Sciences
Modality
Cell Therapies
Administration
Topical
01

Overview

MyOwn Skin™ is an autologous skin graft therapy developed by BioLab Sciences for the treatment of chronic wounds, severe burns, and diabetic foot ulcers. The technology, originally developed by Keraderm in Colombia, involves taking a small sample of the patient's own skin and expanding it into full-thickness skin grafts (up to three 4-inch x 4-inch sheets) within 5-7 days through a proprietary non-surgical process. As a cell and tissue-based biological product (HCT/P), it aims to eliminate the need for traditional large-area donor site harvesting. However, following a 2022 FDA warning letter regarding its classification as a biologic requiring an Investigational New Drug (IND) application, the company voluntarily paused distribution to pursue the necessary regulatory approvals.

Brand names
MyOwn Skin
Other names
Keraderm

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