LYell SYndrome MEsenchymal Stromal Cells Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2027-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Epidermal Necrolysis Lyell Syndrome Toxic Epidermal Necrolysis Overlap Syndrome Mesenchymal Stromal Cells Adipose Derived Stromal Cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adipose derived stromal cells intravenously injected

Group Type EXPERIMENTAL

Adipose derived stromal cells intravenously injected

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)
* Who, after the nature of the study has been explained to them or a support person (if applicable), and prior to any protocol specific procedures being performed, have given written consent according to local regulatory requirements
* 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
* Detection of Coronavirus SARS CoV-2 RNA on admission (positive RT-PCR), if performed in the usual care
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No