Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516404-42-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adipose derived stromal cells intravenously injected | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adipose derived stromal cells intravenously injected | Drug | 2×10^6/kg of Adipose derived stromal cells A single injection at D0 (performed maximum three days post-admission). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety : Observation of at least one adverse effect | Day 10 | |
| Efficacy : Rate of complete or almost complete reepithelialisation | Day 7 after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of observed and predicted death by the SCORTEN | at one month | |
| Duration of hospitalisation according to our historical cohort related to BSA involved | Month 12 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saskia Oro, MD | Contact | 0149812536 | +33 | saskia.oro@aphp.fr |
| Charline Menanteau, MSc | Contact | 0144841752 | myriem.carrier@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Saskia Oro, PhD | saskia.oro@aphp.fr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri Mondor | Recruiting | Créteil | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17805350 | Background | Mockenhaupt M, Viboud C, Dunant A, Naldi L, Halevy S, Bouwes Bavinck JN, Sidoroff A, Schneck J, Roujeau JC, Flahault A. Stevens-Johnson syndrome and toxic epidermal necrolysis: assessment of medication risks with emphasis on recently marketed drugs. The EuroSCAR-study. J Invest Dermatol. 2008 Jan;128(1):35-44. doi: 10.1038/sj.jid.5701033. Epub 2007 Sep 6. | |
| 27317286 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013262 | Stevens-Johnson Syndrome |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003875 | Drug Eruptions |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Duration of hospitalisation according to our historical cohort related to onset of the disease |
| Month 12 |
| Duration of hospitalisation according to our historical cohort related to SCORTEN | Month 12 |
| Duration of each mucous membranes healing ie.(buccal, nasal, genital, eyes) | at Month 12 |
| Rate of sepsis | at Month 12 |
| Rate of intensive care transfer | at Month 12 |
| Rate of sequelae | at Month 12 |
| Th1/Th2 immune response in the peripheral blood of the patients | 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 | after injection at Day 0, Day 10, Month 1. |
| Epidermal chimerism study on healed skin biopsy | 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. | at Day 5, Day 10 and Day15 |
| Creamer D, Walsh SA, Dziewulski P, Exton LS, Lee HY, Dart JK, Setterfield J, Bunker CB, Ardern-Jones MR, Watson KM, Wong GA, Philippidou M, Vercueil A, Martin RV, Williams G, Shah M, Brown D, Williams P, Mohd Mustapa MF, Smith CH. U.K. guidelines for the management of Stevens-Johnson syndrome/toxic epidermal necrolysis in adults 2016. Br J Dermatol. 2016 Jun;174(6):1194-227. doi: 10.1111/bjd.14530. No abstract available. |
| 21367635 | Background | Roux S, Leotot J, Chevallier N, Bierling P, Rouard H. [Mesenchymal stromal cells: Biological properties and clinical prospects]. Transfus Clin Biol. 2011 Feb;18(1):1-12. doi: 10.1016/j.tracli.2011.01.001. Epub 2011 Mar 1. French. |
| 19780713 | Background | Chung HM, Won CH, Sung JH. Responses of adipose-derived stem cells during hypoxia: enhanced skin-regenerative potential. Expert Opin Biol Ther. 2009 Dec;9(12):1499-508. doi: 10.1517/14712590903307362. |
| 28476287 | Result | Duong TA, Valeyrie-Allanore L, Wolkenstein P, Chosidow O. Severe cutaneous adverse reactions to drugs. Lancet. 2017 Oct 28;390(10106):1996-2011. doi: 10.1016/S0140-6736(16)30378-6. Epub 2017 May 2. |
| D003872 |
| Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004892 | Erythema Multiforme |
| D004890 | Erythema |
| D012872 | Skin Diseases, Vesiculobullous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |