Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT02810951
Eligibility Criteria:
Key Inclusion Criteria:
1. Age
1. Phase I: Eighteen (18) years or older.
2. Phase II: Seven (7) years or older.
2. Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB)
Key Exclusion Criteria:
1. Medical instability limiting ability to travel to the investigative center.
2. Active infection with HIV, hepatitis B or hepatitis C or evidence of other systemic infection
3. Current evidence of metastatic squamous cell carcinoma at the site to be injected
4. Clinically significant abnormal laboratory result or other significant clinical abnormalities
5. Receipt of a chemical or biological study product for the specific treatment of RDEB in the past six months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Study:
NCT02810951
Study Brief:
Protocol Section:
NCT02810951