Henri Mondor
Créteil, France
Location status: Recruiting
NCT Number: NCT04711200
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Créteil, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2×10^6/kg of Adipose derived stromal cells A single injection at D0 (performed maximum three days post-admission).
Time frame: Day 10
Time frame: Day 7 after infusion
Time frame: at one month
Time frame: Month 12
Time frame: Month 12
Time frame: Month 12
Time frame: at Month 12
Time frame: at Month 12
Time frame: at Month 12
Time frame: at Month 12
Time frame: after injection at Day 0, Day 10, Month 1
Time frame: after injection at Day 0, Day 10, Month 1.
Time frame: at 1 month
Time frame: at Day 5, Day 10 and Day15
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Mesenchymal Stromal Cells Treatment in Lyell Syndrome: A Pilot Phase 1-2 Open Trial
Acronym: LYSYME
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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