A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa

Trial ID or NCT#

NCT04213261

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: Older than 2 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Male or female ≥2 years of age at the Screening visit.* Clinical diagnosis of RDEB with confirmation of COL7A1 genetic mutation.
    1. Key
Exclusion Criteria:
  1. * 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.
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Investigator(s)

M. Peter Marinkovich, MD
M. Peter Marinkovich, MD
Dermatologist, Blistering disease specialist, Psoriasis specialist
Associate Professor of Dermatology

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Contact

Kunju J Sridhar, PhD
650-721-4902

View on ClinicalTrials.gov