Mesenchymal stromal cell treatment for Lyell syndrome (SJS/TEN)
Official title: Mesenchymal Stromal Cells Treatment in Lyell Syndrome: A Pilot Phase 1-2 Open Trial
Run by Assistance Publique - Hôpitaux de Paris · NCT04711200 · Data updated 2026-11-12
This will try intravenous adipose-derived mesenchymal stromal cells in adults with recent-onset Stevens–Johnson syndrome or toxic epidermal necrolysis to see if skin heals faster.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Créteil) |
| Status | Recruiting |
| Started | April 15, 2024 |
| Main results expected | April 2027 |
| Study ends | April 2027 |
| Registry record updated | August 1, 2025 |
| Trial ID | NCT04711200 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 years old with confirmed SJS/TEN hospitalized within 10 days of first symptoms and with at least 10% detachable body surface area who can give informed consent.
✕Probably not a fit
Patients who are pregnant or breastfeeding, have recent or metastatic cancer, are HIV-positive, have active hepatitis B or C, test positive for SARS-CoV-2, present after 10 days, or have less than 10% detachable BSA are unlikely to be eligible or to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 1/2 interventional trial giving intravenous adipose-derived mesenchymal stromal cells to hospitalized adults with confirmed SJS/TEN within 10 days of symptom onset and at least 10% detachable body surface involvement. Participants receive MSC infusions in addition to standard supportive care and are monitored for safety, healing speed, and other clinical outcomes. Key exclusions include pregnancy, recent malignancy, HIV, active hepatitis B or C, and current SARS-CoV-2 infection. The protocol is conducted at Henri Mondor Hospital in Créteil, France.
Why it matters
Potential benefit: If successful, the treatment could speed re-epithelialization, reduce skin loss and complications, and shorten hospital stays for people with SJS/TEN.
How similar studies have gone: Mesenchymal stromal cells have shown promising results in burn wound healing, cutaneous radiation injury, and refractory GVHD, but their use in SJS/TEN is novel with limited clinical data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
Henri Mondor
Créteil, France Recruiting
Study contacts
- Principal investigator: Saskia Oro, PhD — saskia.oro@aphp.fr
- Study coordinator: Saskia Oro, MD
- Email: saskia.oro@aphp.fr
- Phone: 0149812536
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.