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 C7 expression and the presence of anchoring fibrils resulting from FCX-007 and to analyze wound healing as a result of FCX-007 administration in subjects with RDEB.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Fibrocell Technologies, Inc.

Collaborator: Intrexon Corporation

Stanford Investigator(s):

Intervention(s):

  • Genetic: FCX-007
  • Drug: Sterile Saline

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   1. Age

      1. Phase I (subjects 1 through 6): Eighteen (18) years or older.

      2. Phase II (subjects 7 through 12): Seven (7) years or older.

   2. Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB)

   3. NC1/NC2 Status (to be tested for if unknown)

   4. Subjects, who are, in the opinion of the Investigator, able to understand the study,
   co-operate with the study procedures and are willing to return to the clinic for all
   the required follow-up visits

Exclusion Criteria:

   1. Medical instability limiting ability to travel to the investigative center.

   2. Active infection with HIV, hepatitis B or hepatitis C

   3. A positive study specific immunofluorescence result

   4. Evidence of systemic infection

   5. Current evidence of metastatic squamous cell carcinoma at the site to be injected

   6. Known allergy to any of the constituents of the product

   7. Active drug or alcohol addiction

   8. Hypersensitivity to type of anesthesia chosen

   9. Receipt of a chemical or biological study product for the specific treatment of RDEB
   in the past six months

10. Women who are pregnant or breast-feeding

11. Abnormal clinically significant laboratory result

12. Clinically significant abnormalities on NCI toxicity scale

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