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Clinical Trial VICCNCPED1210


Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients with Dystrophic Epidermolysis Bullosa.

Principal Investigator(s)

Haydar Frangoul


  • Protocol No. VICCNCPED1210
  • Open Date: 02/20/2012
  • Staging: Pilot
  • Age Group: Children
  • Scope: Local
  • Objective: To determine the feasibility of using GCSF in patients with dystrophic epidermolysis bullosa.
  • Disease Sites: None Specified
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Filgrastim (GCSF)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01538862
  • Secondary Protocol No: Not Specified


None Provided.


Ages Eligible for Study:N/A and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No


Inclusion Criteria:
• Each patient must have the diagnosis of severe generalized recessive dystrophic EB (formerly known as Hallopeau-Siemens RDEB) confirmed by clinical criteria and either of the following:
1. transmission electron microscopy
2. immunofluorescence antigenic mapping and type VII collagen monoclonal antibody staining
3. COL7A1 mutational analysis
Exclusion Criteria:
• The patient must not have a history of squamous cell carcinoma or any internal malignancy.
• Female patients who are pregnant.
• Patients with active signs and symptoms of infection.