About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Adipose derived stromal cells intravenously injected
Drug2×10\^6/kg of Adipose derived stromal cells A single injection at D0 (performed maximum three days post-admission).
Treatment groups
Trial outcomes
Primary outcomes
Safety : Observation of at least one adverse effect
Efficacy : Rate of complete or almost complete reepithelialisation
Secondary outcomes
Rate of observed and predicted death by the SCORTEN
Duration of hospitalisation according to our historical cohort related to BSA involved
Duration of hospitalisation according to our historical cohort related to onset of the disease
Duration of hospitalisation according to our historical cohort related to SCORTEN
Sponsors and contacts
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