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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

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

Recruiting
18-80 years
All
Phase N/A

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Overview

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).

Eligibility

Inclusion Criteria:

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 Criteria:

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

Study details
    Epidermolysis Bullosa Dystrophica

NCT06177353

Assistance Publique - Hôpitaux de Paris

14 October 2025

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