Clinical Trials

LYell SYndrome MEsenchymal Stromal Cells Treatment

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients aged from 18 to 75 years-old.

- Admission less than 10 days after onset of the reaction.

- 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) - Written consent from patient or trustworthy person or legal representant or family member.

- Affiliated to a social security scheme.

Exclusion Criteria:

- 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.

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04711200
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Assistance Publique - Hôpitaux de Paris
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Saskia Oro, MD
Principal Investigator Affiliation	[email protected]
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Epidermal Necrolysis, Lyell Syndrome, Toxic Epidermal Necrolysis, Overlap Syndrome, Mesenchymal Stromal Cells, Adipose Derived Stromal Cells

Arms & Interventions

Arms

Experimental: Adipose derived stromal cells intravenously injected

Interventions

Drug: - Adipose derived stromal cells intravenously injected

2×10^6/kg of Adipose derived stromal cells A single injection at D0 (performed maximum three days post-admission).

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Saskia Oro, MD

[email protected]

0149812536

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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