Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Henri Mondor
Créteil, France
Actively Recruiting
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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