Status:
WITHDRAWN
Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes
Lead Sponsor:
Stanford University
Conditions:
Epidermolysis Bullosa
Eligibility:
All Genders
18+ years
Phase:
NA
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 gen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01454687
Start Date
October 1 2011
Last Update
April 11 2014
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