Actively 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
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-07-17
30
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 mucocutaneous fragility and abnormal healing directly related to quantitative and/or qualitative constitutional abnormalities of collagen VII but also to a contingent cutaneous and systemic inflammatory component. This inflammatory aspect contributes to the perpetuation of skin lesions and delayed healing. Our primary objective is to define the systemic immunological/inflammatory signature of patients with RDEB with an aim to develop a strategy that involves using stem cells with high immunomodulatory/anti-inflammatory capacity such as allogeneic placental stem cells (WJ-MSCs and trophoblasts).
CONDITIONS
Official 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...
- Patients aged 18 to 80 years old with clinically, histologically, and/or genetically confirmed intermediate, reversed or generalized, moderate to severe RDEB
- Adults aged 18 to 80 years old who are healthy controls, including blood donors, skin biopsy donors from abdominoplasty, and donors of soiled bandages from wound dressings
- Written informed consent signed by the participant and investigator before any study procedures
- Participants must be affiliated with or benefit from a social security scheme
You will not qualify if you...
- Patients with epidermolysis bullosa other than intermediate, reversed or generalized RDEB, or with no definite diagnosis
- Use of systemic anti-inflammatory or immunosuppressive therapy for less than one month before inclusion
- Refusal to undergo skin biopsy
- Healthy controls with acute or chronic systemic or skin inflammatory diseases at sampling
- Healthy controls on immunosuppressive or anti-inflammatory treatment within one month prior to sampling
- Persons under legal guardianship, curatorship, or deprived of liberty by judicial or administrative 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
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
CONTACT
J
Jérôme Lambert, Pr
CONTACT
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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