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

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What is this study about?

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.

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 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 Treatment administration

The medication will be administered through an intravenous injection

This marks Day 0 of your treatment timeline

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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.04.2024

Trial locations

Investigated drugs:

Allogeneic Adipose-Derived Mesenchymal Stromal Cells, Ex-Vivo Expanded

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.

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 ID:

2024-516404-42-00

Protocol code:

P150941J

NCT ID:

NCT04711200

Trial Phase:

Human Pharmacology (Phase I) – Other

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?