Trial Search Results

Topical Beremagene Geperpavec (KB103) Gene Therapy to Restore Functional Collagen VII for the Treatment of Dystrophic Epidermolysis Bullosa

This study is being conducted to determine if topical Beremagene Geperpavec (KB103, HSV1-COL7) can safely and effectively promote healing of DEB patient wounds (primary endpoint) and to assess change from baseline in Investigator Global Assessments and Patient Reported Outcomes (secondary endpoint).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Krystal Biotech, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: Topical beremagene geperpavec

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Clinical diagnosis of the recessive form of dystrophic epidermolysis bullosa.

   - Age

      1. 2 subjects: 18 years old or older,

      2. 2 subjects: 5 years old or older.

   - At least one wound that is between 10 and 20 cm2 in wound area.

   - 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 visit

Exclusion Criteria:

   - The presence of medical illness expected to complicate participation

   - Serum antibodies to type collagen VII

   - Active infection in the area that will undergo injection.

   - Evidence of systemic infection.

   - Current evidence or a history of squamous cell carcinoma in the area that will undergo
   treatment.

Ages Eligible for Study

5 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kunju Sridhar, PhD
408-348-0614
Recruiting