Status:
RECRUITING
Study of the Blood and Skin Immunological Profile of Patients With Recessive Dystrophic Epidermolysis Bullosa: in Vivo Analysis and the Impact of Placental Stem Cells in Vitro
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Epidermolysis Bullosa Dystrophica
Eligibility:
All Genders
18-80 years
Brief Summary
Patients with recessive dystrophic epidermolysis bullosa (RDEB) suffer from acute and chronic post-bullous wounds along with impaired skin healing. These issues are attributed not only to mucocutaneou...
Eligibility Criteria
Inclusion
- EBDR patients :
- Patients aged 18 to 80 years old
- Clinically, histologically, and/or genetically confirmed intermediate, reversed or generalized, moderate to severe EBDR
- Healthy controls :
- Adults aged 18 to 80 years old
- PBMC healthy donors: subjects who have donated blood to the EFS according to the indication criteria who have consented to the use of their samples for research purposes.
- Healthy skin biopsy donors: subjects undergoing abdominoplasty scheduled in plastic surgery and who have given their consent for the collection of a skin biopsy from post-operative abdominoplasty skin remnants.
- Healthy donors of bandages soiled with exudates from cutaneous wounds: subject consulting a plastic surgery department as part of their usual post-operative follow-up, who have given their consent for the collection of one of their dressings during their usual during their usual renewal.
- For all subjects :
- Free, informed, written consent, signed by the person and the investigator no later than the day of inclusion and before any examination carried out as part of the study.
- Person affiliated or benefiting from a social security scheme
Exclusion
- EBDR patients :
- EBH with no definite diagnosis or other than EBDR intermediate, reversed or generalized
- Systemic anti-inflammatory or immunosuppressive therapy for less than one month
- Refusal of skin biopsy
- Healthy controls :
- Acute or chronic systemic or cutaneous inflammatory disease at the time of sampling
- Current immunosuppressive anti-inflammatory treatment in the month prior to sampling
- For all subjects:
- Persons under guardianship or curatorship, or deprived of their liberty by judicial or administrative decision
- Patients receiving State Medical Aid
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
April 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 15 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06177353
Start Date
April 15 2024
End Date
April 15 2025
Last Update
July 17 2024
Active Locations (2)
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1
Hopital Saint Louis - Service de chirurgie plastique reconstructrice et esthétique et traitement chirurgical des brûlés
Paris, France
2
Hopital Saint Louis - service dermatologie
Paris, France