LYell SYndrome MEsenchymal Stromal Cells Treatment

Recruiting now · Phase 1/Phase 2

Conditions studied: Epidermal Necrolysis, Lyell Syndrome, Toxic Epidermal Necrolysis, Overlap Syndrome, Mesenchymal Stromal Cells, Adipose Derived Stromal Cells

In brief

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.

Key facts

Study ID: NCT04711200
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 15
Starts: 2024-04-15
Expected to finish: 2027-04-01
Last updated by the study team: 2025-08-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Henri Mondor — Créteil, France (enrolling)

Full record on ClinicalTrials.gov

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