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Treatment with Mesenchymal Stromal Cells for Adults with Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS-TEN) Affecting More Than 10% of Body Surface

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Stevens-Johnson Syndrome-Toxic Epidermal Necrolysis (SJS-TEN), a severe skin condition where at least 10% of the body surface area is affected. This rare and serious condition causes the top layer of skin to detach from the lower layers, similar to severe burns. The treatment being investigated uses allogeneic mesenchymal stromal cells, which are specialized cells derived from donated fat tissue that have been processed and expanded in a laboratory.

The purpose of this research is to evaluate if these cells, when given through intravenous injection, are safe to use and can help heal the skin in patients with SJS-TEN. The treatment involves giving patients a specific dose of these cells based on their body weight. During the study, doctors will monitor how quickly the skin heals and check for any side effects from the treatment.

Participants will receive the cell treatment and will be monitored for several months afterward. The medical team will assess skin healing, particularly in the first week after treatment, and continue to observe the recovery of affected areas including the mouth, nose, eyes, and genital regions. They will also track the overall recovery and any lasting effects of the condition for up to one year after treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your diagnosis of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS-TEN) will be confirmed, with at least 10% of body surface area affected

    This evaluation must occur within 10 days of your first symptoms

  2. Step 2

    Treatment preparation

    You will receive mesenchymal stromal cells derived from adipose tissue

    The treatment dose will be calculated based on your weight (2 million cells per kilogram of body weight)

    The medication will be prepared as a suspension for injection

  3. Step 3

    Treatment administration

    The medication will be administered through an intravenous injection

    This marks Day 0 of your treatment timeline

  4. Step 4

    Initial monitoring period

    Your skin healing will be closely monitored for the first 7 days after injection

    The goal is to achieve at least 90% healing of affected skin areas by Day 7

  5. Step 5

    Extended monitoring

    Additional skin healing assessments will occur on Days 5, 10, and 15

    Blood samples will be collected on Day 0, Day 10, and at 1 month

    A skin sample and blood test will be taken at 1 month to analyze healing

  6. Step 6

    Long-term follow-up

    Your recovery will be monitored for any lasting effects

    A final assessment will be conducted at 12 months after treatment

Who can join the trial?

11 criteria

  • Must be between 18 and 75 years old
  • Must be admitted to hospital within 10 days of first symptoms appearing
  • Must have confirmed diagnosis of SJS-TEN and be hospitalized in either the Dermatology department or intensive care unit
  • Must have at least 10% of body surface area affected by the condition within first 10 days of symptoms
  • Must be able to provide written informed consent after having the study explained (can be given by a support person if applicable)
  • Must be enrolled in a social security scheme
  • For tissue donors only:
    • Must be between 18 and 55 years old
    • Must be scheduled for planned abdominal liposuction surgery
    • Must provide written consent
    • Must complete a health history questionnaire
    • Must be enrolled in social security scheme

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Pregnant or breastfeeding women
  • Active infection not related to SJS-TEN (SJS-TEN stands for Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, which are severe skin reactions)
  • Less than 10% of body surface area affected by the condition
  • History of cancer within the past 5 years
  • Severe liver disease (problems with liver function)
  • Severe kidney disease (problems with kidney function)
  • Uncontrolled diabetes (blood sugar levels not well managed)
  • Severe heart conditions
  • Current participation in other clinical trials
  • Unable to provide informed consent
  • Known allergies to study medications or their components
  • Immunocompromised condition (weakened immune system)
  • History of severe allergic reactions
  • Mental health conditions that could interfere with study participation
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Investigated drugs

  • Mesenchymal Stromal Cells (MSCs)

    are specialized cells that can be harvested from adult tissues, typically from fat or bone marrow. In this trial, they are being studied as a treatment for Lyell syndrome (also known as Toxic Epidermal Necrolysis). These cells have natural healing properties and can help repair damaged skin tissue. They work by reducing inflammation and promoting tissue regeneration, which could help patients recover from severe skin reactions.

  • Adipose-derived Stem Cells (ASCs)

    are a specific type of mesenchymal stromal cells that are obtained from fat tissue. These cells are being tested for their ability to help heal the skin damage caused by Lyell syndrome. They are administered through infusion and are expected to promote faster skin healing and reduce inflammation in patients with severe skin reactions.

What is already known about the treatment

Mesenchymal Stromal Cells (MSCs) - A specialized cellular therapy administered through intravenous infusion, specifically studied for treating Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (SJS-TEN). These cells are derived from adipose tissue and are being investigated in clinical trials at a dosage of 2 million cells per kilogram of body weight. MSCs work by modulating the immune system and promoting tissue repair through their anti-inflammatory and regenerative properties, potentially helping patients with severe skin conditions affecting more than 10% of their body surface area. This biological treatment represents an innovative approach in regenerative medicine, currently being evaluated in phase 1-2 clinical trials for its safety and ability to promote skin healing.

Investigated diseases

Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (SJS-TEN) - A rare and severe skin reaction that causes the top layer of skin to detach from the lower layers. The condition begins with flu-like symptoms, followed by a painful rash that spreads and blisters. As the condition progresses, the skin begins to peel off in sheets, leaving large raw areas exposed. It affects the skin and mucous membranes, including the mouth, eyes, and genitals. The condition typically starts on the face and trunk before spreading to other parts of the body. SJS-TEN is considered a spectrum of the same condition, with TEN being the more severe form involving more body surface area.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516404-42-00Protocol codeP150941JEstimated enrolment30 patientsSponsorAssistance Publique Hopitaux De Paris

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