A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Trial ID or NCT#
NCT02810951
Status
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. 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 infection 3. Current evidence of metastatic squamous cell carcinoma at the site to be injected 4. Clinically significant abnormal laboratory result or other significant clinical abnormalities 5. Receipt of a chemical or biological study product for the specific treatment of RDEB in the past six months
Investigator(s)
M. Peter Marinkovich, MD
Dermatologist,
Blistering disease specialist,
Psoriasis specialist
Associate Professor of Dermatology
Contact us to find out if this trial is right for you.
Contact
Kunju Sridhar, Ph. D
408-348-0614
View on ClinicalTrials.gov
