LYell SYndrome MEsenchymal Stromal Cells Treatment

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAssistance Publique - Hôpitaux de Paris

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Adipose derived stromal cells intravenously injectedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety : Observation of at least one adverse effect

Time frame
Day 10
2

Efficacy : Rate of complete or almost complete reepithelialisation

Time frame
Day 7 after infusion

Secondary outcomes

1

Rate of observed and predicted death by the SCORTEN

Time frame
at one month
2

Duration of hospitalisation according to our historical cohort related to BSA involved

Time frame
Month 12
3

Duration of hospitalisation according to our historical cohort related to onset of the disease

Time frame
Month 12
4

Duration of hospitalisation according to our historical cohort related to SCORTEN

Time frame
Month 12

Other outcomes

Sponsors and contacts

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