Trial Search Results

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

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

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Castle Creek Biosciences, LLC.

Stanford Investigator(s):

Intervention(s):

  • Genetic: FCX-007

Phase:

Phase 1/Phase 2

Eligibility


Key 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

Ages Eligible for Study

7 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kunju Sridhar, Ph. D
408-348-0614
Recruiting