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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
2×10\^6/kg of Adipose derived stromal cells A single injection at D0 (performed maximum three days post-admission).
Henri Mondor
Créteil, France
RECRUITINGSafety : Observation of at least one adverse effect
Time frame: Day 10
Efficacy : Rate of complete or almost complete reepithelialisation
Time frame: Day 7 after infusion
Rate of observed and predicted death by the SCORTEN
Time frame: at one month
Duration of hospitalisation according to our historical cohort related to BSA involved
Time frame: Month 12
Duration of hospitalisation according to our historical cohort related to onset of the disease
Time frame: Month 12
Duration of hospitalisation according to our historical cohort related to SCORTEN
Time frame: Month 12
Duration of each mucous membranes healing ie.(buccal, nasal, genital, eyes)
Time frame: at Month 12
Rate of sepsis
Time frame: at Month 12
Rate of intensive care transfer
Time frame: at Month 12
Rate of sequelae
Time frame: at Month 12
Th1/Th2 immune response in the peripheral blood of the patients
Time frame: after injection at Day 0, Day 10, Month 1
Evaluation of expression profile of Th1/Th2 associated chemokines and anti-inflammatory chemokines in the peripheral blood
Time frame: after injection at Day 0, Day 10, Month 1.
Epidermal chimerism study on healed skin biopsy
Time frame: at 1 month
Cutaneous re-epithelialization rate at D5, D10 and D15 post-infusion according to the percentage of cutaneous BSA re-epithelialized in comparison to maximal cutaneous detachable-detached BSA observed.
Time frame: at Day 5, Day 10 and Day15
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