Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT04711200

LYell SYndrome MEsenchymal Stromal Cells Treatment

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-08-01

15

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare severe cutaneous adverse reactions (SCARs) to drugs. To date, no curative drug has demonstrated with a good level of evidence its ability to promote SJS and TEN healing and could contribute to earlier reepithelialisation. Mesenchymal stroma cells (MSCs) therapy represents a new therapeutic approach. eg, in patients with cardiovascular diseases, neurological diseases, renal transplantation, lung diseases as acute respiratory distress syndrome. Recently, MSCs have been proposed in both burn wound healing with a significantly decrease of the unhealed burn area and in cutaneous radiation. Moreover, MSCs have immunomodulation properties potentially effective in refractory acute and chronic graft versus host disease (GVHD) by improving thymic function and induction of Tregs. Indeed, MSCs are able to migrate to inflamed tissues after stimulation by pro-inflammatory cytokines and to modulate the local inflammatory reactions. MSCs have also demonstrated their ability to promote tissue remodelling, angiogenesis and immunomodulation through either differentiation or secretion of several growth factors such as VEGF, basic FGF and various cytokines. Therefore, combining their immunomodulation effect and secretion of soluble factors involved in wound repair, MSCs might be valuable as a cell therapy strategy for promoting cutaneous healing in SJS-TEN syndrome and subsequently decrease the morbi-mortality.

CONDITIONS

Official Title

LYell SYndrome MEsenchymal Stromal Cells Treatment

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 to 75 years old
  • Admission within 10 days after the first symptoms of the disease
  • Confirmed SJS-TEN diagnosis hospitalized in dermatology or intensive care
  • At least 10% detachable or detached body surface area within 10 days after symptoms
  • Provided written consent before any study procedures
  • Affiliated to a social security scheme
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • History of malignant disease within the past ten years or presence of metastasis
  • Positive HIV serology
  • Active hepatitis B or C infection
  • Positive SARS CoV-2 RNA test on admission if performed
  • Decompensated cardiac failure
  • Uncontrolled epilepsy
  • Previous allogenic bone marrow transplantation
  • Participation in other interventional drug research
  • Patient deprived of liberty by judicial or administrative decision or under justice protection
  • Psychological, familial, sociological, or geographical conditions hampering protocol compliance
  • Patient under tutorship or curatorship
  • Patient under psychiatric care according to art. L1121-6 CSP

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Henri Mondor

Créteil, France

Actively Recruiting

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Research Team

S

Saskia Oro, MD

CONTACT

C

Charline Menanteau, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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