Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes

NCT ID: NCT01454687

Last Updated: 2014-04-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31

Brief Summary

The term epidermolysis bullosa (EB) is used to describe a group of genetic skin diseases associated with skin weakness, blisters, and chronic wounds. "Revertant mosaicism" means that there are two genetically different populations of cells due to spontaneous mutations. Some EB patients have normal, non-fragile skin patches which may be areas of revertant mosaicism. In the revertant areas, the proteins function normally, like non-EB skin. In this study, we plan to culture cells from the revertant areas and graft them on to the wounded areas.

Conditions

Epidermolysis Bullosa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Grafting of Autologous Cultured Revertant Keratinocytes

Grafting of two to four epidermal sheets 40cm2 - 50cm2 onto wounded areas

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of EB (simplex, junctional or dystrophic)
• Areas of revertant skin that has been confirmed by biopsy
• 18 years or older subject willing and able to give consent
• Confirmation of EB diagnosis by immunofluorescence (IF), electron microscopy (EM), and genetic testing confirming mutation
• At least 100 to 200 cm2 of open erosions on the trunk and/or extremities suitable for skin grafting
• Able to undergo adequate anesthesia to allow grafting procedures to take place

Exclusion Criteria

• Medical instability limiting ability to travel to Stanford University Medical Center
• The presence of medical illness expected to complicate participation and/or compromise the safety of this technique
• Active infection with HIV, hepatitis B, or hepatitis C
• Active infection in the area that will undergo grafting
• Evidence of a systemic infection
• Current evidence or a history of skin cancer in the area that will undergo grafting
• Active drug or alcohol addiction
• Hypersensitivity to vancomycin or amikacin
• Receipt of chemical or biological study product for the specific treatment ofEB in the past six months
• Positive pregnancy test or breast-feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Alfred Lane

Professor, Departments of Dermatology and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alfred Lane, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Other Identifiers

IRB # 22005

Identifier Type: -

Identifier Source: org_study_id