Actively Recruiting
Study of the Blood and Skin Immune Profile in Patients With Recessive Dystrophic Epidermolysis Bullosa and the Laboratory Impact of Placental Stem Cells
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-07-17
30
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with recessive dystrophic epidermolysis bullosa (RDEB), a condition causing fragile skin and chronic wounds with delayed healing. The study aims to understand the immune and inflammatory patterns in these patients to explore treatments using stem cells that may help reduce inflammation and support healing. The study involves collecting blood samples, skin biopsies, and soiled bandages from both RDEB patients and healthy volunteers. The focus is on analyzing immune cells and molecules in the blood and skin, as well as testing the effects of placental stem cells and extracellular vesicles in laboratory settings. Participants will provide samples for up to one year while researchers examine immune responses and inflammation markers. The study measures include cellular and cytokine signatures in blood, and the impact of stem cells on immune activity. Consent and social security affiliation are required, and safety monitoring will be ongoing during the study period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Patients with clinically, histologically, or genetically confirmed moderate to severe recessive dystrophic epidermolysis bullosa (RDEB)
- Healthy adults aged 18 to 80 years who have consented to blood donation or skin biopsy for research purposes
- Healthy donors of bandages soiled with wound exudates who have given consent
- Free, informed, written consent signed by participant and investigator before any study procedures
- Affiliated with or benefiting from a social security scheme
You will not qualify if you...
- Patients with epidermolysis bullosa forms other than intermediate, reversed, or generalized RDEB
- Systemic anti-inflammatory or immunosuppressive therapy for less than one month
- Refusal to undergo skin biopsy
- Healthy controls with acute or chronic inflammatory diseases at sampling
- Current immunosuppressive or anti-inflammatory treatment within one month before sampling
- Persons under guardianship, curatorship, or deprived of liberty by legal decision
- Patients receiving State Medical Aid
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo blood sampling, skin biopsy, and collection of soiled bandages for research purposes.
Visits as needed for sample collection over up to 1 year
Trial Site Locations
Total: 2 locations
1
Hopital Saint Louis - Service de chirurgie plastique reconstructrice et esthétique et traitement chirurgical des brûlés
Paris, France
Actively Recruiting
2
Hopital Saint Louis - service dermatologie
Paris, France
Actively Recruiting
Research Team
E
Emmannuelle Bourrat, Pr
J
Jérôme Lambert, Pr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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