FCX-007 (dabocemagene autoficel; see below for FCX-007 description)
FCX-007 (dabocemagene autoficel; see below for FCX-007 description): FCX-007 is comprised of fibroblasts isolated from the subject's skin biopsies which are genetically corrected with the full length COL7A1 gene encoding for type VII collagen.
Study summary
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
Eligibility
Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Complete Wound Closure of the First Wound Pair at Week 24 — Week 24 Complete wound closure of the first wound pair (treated vs. control)
Trial sites (5)
Facility
City
Region
Status
Stanford University
Stanford
California
Children's Hospital Colorado
Aurora
Colorado
Solutions Through Advanced Research, Inc.
Jacksonville
Florida
Mayo Clinic
Rochester
Minnesota
Dell Children's Medical Group
Austin
Texas
More Castle Creek Biosciences, LLC. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.