A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa

Not Recruiting

Trial ID: NCT04213261


The purpose of this study is to determine whether administration of FCX-007 in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with Recessive Dystrophic Epidermolysis Bullosa. Funding Source - FDA OOPD

Official Title

A Pivotal Phase 3 Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa

Stanford Investigator(s)

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

Associate Professor of Dermatology


Key Inclusion Criteria:

   - Male or female ≥2 years of age at the Screening visit.

   - Clinical diagnosis of RDEB with confirmation of COL7A1 genetic mutation.

Key Exclusion Criteria:

   - Medical instability limiting ability to travel to the investigative site.

   - Active infection with human immunodeficiency virus, hepatitis B or hepatitis C.

   - The presence of COL7 antibodies.

   - Evidence of systemic infection.

   - Evidence or history of squamous cell carcinoma at the site to be injected.

   - Evidence of or history of metastatic squamous cell carcinoma.

   - Known allergy to any of the constituents of the product.

   - Female who is pregnant or breastfeeding.

   - Receipt of a chemical or biological intervention for the specific treatment of RDEB in
   the past three (3) months prior to screening or anticipated/planned during the
   screening and treatment period for this study.


biological: FCX-007 (dabocemagene autoficel; see below for FCX-007 description)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kunju J Sridhar, PhD