Status:
RECRUITING
LYell SYndrome MEsenchymal Stromal Cells Treatment
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Epidermal Necrolysis
Lyell Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 evide...
Eligibility Criteria
Inclusion
- Patients ≥ 18 and ≤ 75 years-old
- Admission ≤ 10 days after the index date (date of the first symptoms of the disease)
- Patient with confirmed SJS-TEN diagnosis hospitalized in the department of Dermatology or intensive care medicine
- At least 10 % of detachable-detached body surface area at any time during the first 10 days after the index date (date of the first symptoms of the disease)
- Who, after the nature of the study has been explained to them or a support person (if applicable), and prior to any protocol specific procedures being performed, have given written consent according to local regulatory requirements
- Affiliated to a social security scheme
Exclusion
- Pregnant or breastfeeding women
- History of malignant disease within the past ten years and or presence of metastasis
- Positive serology for HIV
- Active infection for hepatitis B or C
- Detection of Coronavirus SARS CoV-2 RNA on admission (positive RT-PCR), if performed in the usual care
- Decompensated cardiac failure
- Uncontrolled epilepsia
- Previous history of allogenic bone marrow transplantation
- Participation in other interventional drug research Patient deprived of liberty by a judicial or administrative decision or under the protection of justice
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the research protocol and follow-up schedule
- Patient under tutorship or curatorship
- Patient under psychiatric care according to art. L1121-6 CSP
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04711200
Start Date
April 15 2024
End Date
April 1 2027
Last Update
August 1 2025
Active Locations (1)
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1
Henri Mondor
Créteil, France