Epidermolysis bullosa congenita
Conditions
Brief summary
Incidence of adverse events of special interest (AESI): severe local reaction at the injection site other than blistering, severe systemic allergic reaction at any time after MSC administration, severe systemic or local infectious complications at any time after MSC administration (combined primary safety endpoint)
Detailed description
Incidence, type, seriousness, intensity of AEs and their relation to study medication, Percent change in the non-healed area of the area marked in the study active and control lesions from baseline, Estimation of the total area of lesions on the patient's body (% of body surface area), Patient-reported outcomes (itching, ease of wound dressing change)
Interventions
DRUGAllogeneic adipose tissue-derived mesenchymal stromal cells
Sponsors
Masarykova Univerzita
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events of special interest (AESI): severe local reaction at the injection site other than blistering, severe systemic allergic reaction at any time after MSC administration, severe systemic or local infectious complications at any time after MSC administration (combined primary safety endpoint) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence, type, seriousness, intensity of AEs and their relation to study medication, Percent change in the non-healed area of the area marked in the study active and control lesions from baseline, Estimation of the total area of lesions on the patient's body (% of body surface area), Patient-reported outcomes (itching, ease of wound dressing change) | — |
Countries
Czechia
Outcome results
None listed