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

Trial ID or NCT#

NCT02810951

Status

not recruiting iconNOT RECRUITING

Purpose

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)

Eligibility Criteria

Ages Eligible for Study: Older than 7 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Age
  2. 1. Phase I: Eighteen (18) years or older. 2. Phase II: Seven (7) years or older.2. Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB)
    1. Key
Exclusion Criteria:
  1. 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 infection3. Current evidence of metastatic squamous cell carcinoma at the site to be injected4. Clinically significant abnormal laboratory result or other significant clinical abnormalities5. Receipt of a chemical or biological study product for the specific treatment of RDEB in the past six months
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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 Sridhar, Ph. D
408-348-0614

View on ClinicalTrials.gov