Clinical Trial VICCNCPED1210
Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients with Dystrophic Epidermolysis Bullosa.
- 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
|Ages Eligible for Study:||N/A and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• 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
• 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.