RECRUITING

Gentamicin for Junctional Epidermolysis Bullosa

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Herlitz junctional epidermolysis bullosa (H-JEB), an incurable, fatal, inherited skin disease, is caused by loss-of-function mutations in the LAMA3, LAMB3 or LAMC2 genes, resulting in loss of laminin 332 and poor epidermal-dermal adherence. Eighty percent of H-JEB patients have LAMB3 mutations and about 95% of these are nonsense mutations. The investigators recently demonstrated that gentamicin readily induced nonsense mutation readthrough and produced full-length laminin beta3 in several nonsense mutations tested. Importantly, the gentamicin-induced laminin beta3 restored laminin 332 assembly, secretion, and deposition into the dermal-epidermal junction (DEJ). Newly induced laminin 332 reversed abnormal H-JEB cellular phenotypes. Herein, the investigators propose the first clinical trial of gentamicin (by topical and intravenous administration) in JEB patients with nonsense mutations. The milestones will include restored laminin 332 and hemidesmosomes at the DEJ, improved wound closure, and the absence of significant gentamicin side effects.

Official Title

A Pilot Study of the Restoration of Functional Laminin 332 in JEB Patients With Nonsense Mutations After Topical and Intravenous Gentamicin Treatment

Quick Facts

Study Start:2018-06-01
Study Completion:2020-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03526159

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. JEB patients with nonsense mutations in the LAMB3 gene in either one or two alleles.
  1. 1. JEB patients who do not have nonsense mutations in the LAMB3 gene in either allele.
  2. 2. Pre-existing known auditory impairment.
  3. 3. Pre-existing known renal impairment.
  4. 4. Pre-existing known allergies to aminoglycosides or sulfate compounds.
  5. 5. Pregnancy.

Contacts and Locations

Study Contact

Mei Chen, Ph.D.
CONTACT
3238650621
chenm@usc.edu
David Woodley, M.D.
CONTACT
3238650956
dwoodley@usc.edu

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90033
United States

Collaborators and Investigators

Sponsor: University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-06-01
Study Completion Date2020-08-31

Study Record Updates

Study Start Date2018-06-01
Study Completion Date2020-08-31

Terms related to this study

Keywords Provided by Researchers

  • Herlitz
  • Laminin 332
  • Laminin beta 3
  • JEB

Additional Relevant MeSH Terms

  • Junctional Epidermolysis Bullosa