This study is being done to find out if a new type of skin graft, called GMEB-SASS, is safe and effective for helping wounds heal in people with RDEB (Recessive Dystrophic Epidermolysis Bullosa).
The GMEB-SASS graft contains two types of living skin cells: keratinocytes and fibroblasts. It is made in a laboratory using a small sample of the patient's own skin.
To help the patient's skin cells produce a missing protein called type VII collagen, scientists grow the patient's cells in the lab and use a virus-like tool (called a retroviral vector) to give the cells the correct instructions. This allows the cells to make the normal protein that is missing in people with RDEB.
The graft is designed to be permanent, and the goal is to improve wound healing by replacing damaged skin cells with healthy ones.
Age
Subjects 1 to 3: Eighteen (18) years old or older.
Subjects 4 to 6: Twelve (12) years old or older.
Subjects 7 to 9: Seven (7) years old or older.
Medical instability limiting the ability to travel to the investigative center.
Any medical condition or illness that may impact study participation or compromise the safety of the participants, as per the investigator's judgment.
Evidence of systemic infection.
Current evidence or a history of non-metastatic or metastatic squamous cell carcinoma at the site to be grafted.