LYell SYndrome MEsenchymal Stromal Cells Treatment

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Brief Title

LYell SYndrome MEsenchymal Stromal Cells Treatment

Official Title

Mesenchymal Stromal Cells Treatment in Lyell Syndrome: A Pilot Phase 1-2 Open Trial

Brief Summary

      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.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Safety : Observation of at least one adverse effect

Secondary Outcome

 Rate of observed and predicted death by the SCORTEN

Condition

Epidermal Necrolysis

Intervention

Adipose derived stromal cells intravenously injected

Study Arms / Comparison Groups

 Adipose derived stromal cells intravenously injected
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

15

Start Date

September 2022

Completion Date

September 2025

Primary Completion Date

September 2025

Eligibility 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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Saskia Oro, MD, 0149812536, [email protected]



Administrative Informations


NCT ID

NCT04711200

Organization ID

P150941J


Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris


Study Sponsor

Saskia Oro, MD, Principal Investigator, [email protected]


Verification Date

April 2022