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

Completed · Phase 2

Conditions studied: Dystrophic Epidermolysis Bullosa

In brief

This is a feasibility study to see if Granulocyte Colony Stimulating Factor (GCSF) is effective as a treatment of Dystrophic Epidermolysis Bullosa (EB). Patients will receive one course of treatment with the study drug. The course will be 7 days in length. After receiving GCSF, patients will be followed at 7 and 30 days following the discontinuation of the drug. Thirty day follow up can be done via telephone communication with the patient or family.

Key facts

Study ID

NCT01538862

Run by

Vanderbilt University Medical Center

People needed

7

Starts

2012-02-01

Expected to finish

2014-11-01

Last updated by the study team

2017-06-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• transmission electron microscopy
• immunofluorescence antigenic mapping and type VII collagen monoclonal antibody staining
• COL7A1 mutational analysis

You may not qualify if…

• 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.

Where it is running

• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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