Analyzing the immune profile of patients with recessive dystrophic epidermolysis bullosa and the effects of placental stem cells
Etude du Profil Immunologique Sanguin et cutané Des Patients Atteints d'épidermolyse Bulleuse Dystrophique récessive : Analyses in Vivo et Impact Des Cellules Souches Placentaires in Vitro
This study is testing how the immune system works in people with recessive dystrophic epidermolysis bullosa and whether using placental stem cells can help their skin heal better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT06177353 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with recessive dystrophic epidermolysis bullosa (RDEB), a condition characterized by severe skin fragility and delayed healing due to collagen abnormalities and inflammation. The primary goal is to define the systemic immunological and inflammatory profile of these patients. By understanding this profile, the study aims to explore the potential of using allogeneic placental stem cells, known for their immunomodulatory properties, to improve healing outcomes. The study will involve sampling blood and skin from both RDEB patients and healthy controls to compare their immune responses.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with clinically confirmed moderate to severe recessive dystrophic epidermolysis bullosa.
Not a fit: Patients with mild forms of epidermolysis bullosa or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing strategies for patients suffering from RDEB.
How similar studies have performed: While the use of stem cells in treating skin conditions is a growing field, this specific approach focusing on RDEB and placental stem cells is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris and 1 other locations
- Hopital Saint Louis - Service de chirurgie plastique reconstructrice et esthétique et traitement chirurgical des brûlés — Paris, France (Recruiting)
- Hopital Saint Louis - service dermatologie — Paris, France (Recruiting)
Study contacts
- Study coordinator: Emmannuelle Bourrat, Pr
- Email: emmanuelle.bourrat@aphp.fr
- Phone: +33142499090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.