Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Condition or disease
Procedure: Grafting of Autologous Cultured Revertant Keratinocytes
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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