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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Fibrocell Technologies, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: FCX-007 (debcoemagene 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