Clinical Trial VICCNCPED1210
Title
Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients with Dystrophic Epidermolysis Bullosa.
Principal Investigator(s)
Details
- 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:
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Filgrastim (GCSF)
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01538862
- Secondary Protocol No: Not Specified
Description
None Provided.
Eligibility
| Ages Eligible for Study: | N/A and older |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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