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 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT04186650
Eligibility Criteria:
Inclusion Criteria:
1. Clinical and molecular diagnosis of RDEB with confirmed bi-allelic COL7A1 mutations
2. Reduced staining of C7 on skin biopsy, measured by immunofluorescence microscopy (IF)
3. A reduced number of/or morphologically abnormal anchoring fibrils confirmed by TEM
4. Detection of non-collagenous-1 domain (NC-1) of C7 on skin biopsy, measured by immunofluorescence microscopy (IF) and/or Western blot (WB) analysis
5. Presence of ≥100cm2 of blistered and/or erosive skin areas including chronic wounds suitable for skin grafting
6. Ability to undergo anaesthesia for skin grafting procedures
7. Subjects aged 18 years, willing and able to give informed consent
Exclusion Criteria:
1. Recipients of other investigational medicinal products within 6 months prior to enrolment into this study
2. Past medical history of biopsy proven skin malignancy
3. Immunotherapy including oral corticosteroids (Prednisolone \>1mg/kg) for more than one week (intranasal and topical preparations are permitted) or chemotherapy within 60 days of enrolment into this study
4. Known allergy to any of the constituents of the investigational medicinal product (IMP) including Penicillin
5. Subjects with BOTH:
* positive serum antibodies to C7 confirmed by ELISA and
* positive IIF with binding to the base of salt split skin and/or
* positive Western blot
6. Positive results for HIV, Hepatitis BsAg, Hepatitis BcAb, Hepatitis C IgG, HTLV1\&2 or Syphilis serology
7. Clinically significant medical, psychological or laboratory abnormalities limiting the ability of the subject to travel to the trial site(s) and to undergo grafting and follow-up procedures, as determined by the Investigator
8. Absence of adequate social support
9. Subjects who are pregnant, breast-feeding or of child-bearing potential who are neither abstinent nor practicing an acceptable means of contraception when this is in line with the usual and preferred lifestyle of the subject, as determined by the Investigator, for the duration of the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04186650
Study Brief:
Protocol Section:
NCT04186650