Epidermolysis Bullosa Dystrophica Clinical Trial
Official title:
Recessive Dystrophic Epidermolysis Bullosa Screening for Possible Gene Transfer
Verified date | May 2015 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
Recessive Dystrophic Epidermolysis Bullosa (RDEB) is a severe inherited blistering skin disease caused by absence of type VII collagen. Patients with RDEB develop large, severly painful blisters and open wounds from minor trauma to their skin. In the future, we hope to start a gene transfer study on a specific group of RDEB subjects and we are screening subjects for that potential trial now.
Status | Terminated |
Enrollment | 1 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria:1. Clinical diagnosis of RDEB by local dermatologist 2. 18 years of age
or more and willing to give consent 3. Estimated to have at least 100 to 200 sq. cm. areas
of open erosions on the trunk or extremities suitable for skin grafting 4. Ability to
undergo adequate anesthesia to allow grafting procedures to take place 5. Parents are
alive, do not have EB, and they are willing to give consent for genetic testing Exclusion Criteria:1. Medical instability limiting ability to travel to Stanford University Medical Center 2. Participation in another clinical trial without prior approval 3. The presence of medical illness expected to complicate participation and/or compromise the safety of this technique |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease documentation | Documentation of disease | 1 year | No |
Primary | documentation of disease | documentation of disease | 1 year | No |
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