Actively Recruiting

Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT06177353

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

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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