A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)


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Trial ID: NCT02810951


The purpose of this study is to evaluate the safety of FCX-007, evaluate Type VII collagen (COL7) expression and the presence of anchoring fibrils and to analyze wound healing as a result of FCX-007 administration in subjects with recessive dystrophic epidermolysis bullosa (RDEB). Funding Source- FDA OOPD

Official Title

A Phase I/II Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Stanford Investigator(s)

M. Peter Marinkovich, MD
M. Peter Marinkovich, MD

Associate Professor of Dermatology


Key Inclusion Criteria:

   1. Age

      1. Phase I: Eighteen (18) years or older.

      2. Phase II: Seven (7) years or older.

   2. Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB)

Key Exclusion Criteria:

   1. Medical instability limiting ability to travel to the investigative center.

   2. Active infection with HIV, hepatitis B or hepatitis C or evidence of other systemic

   3. Current evidence of metastatic squamous cell carcinoma at the site to be injected

   4. Clinically significant abnormal laboratory result or other significant clinical

   5. Receipt of a chemical or biological study product for the specific treatment of RDEB
   in the past six months


genetic: FCX-007


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kunju Sridhar, Ph. D