Trial Search Results

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Castle Creek Biosciences, LLC.

Stanford Investigator(s):

Intervention(s):

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

Phase:

Phase 3

Eligibility


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.

Ages Eligible for Study

2 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kunju J Sridhar, PhD
650-721-4902
Not Recruiting