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New treatment option for Epidermal Necrolysis
Official title LYell SYndrome MEsenchymal Stromal Cells Treatment
ClinicalTrials.gov ID: NCT04711200
What this study is testing
What is Adipose derived stromal cells intravenously injected?
Adipose derived stromal cells intravenously injected is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for epidermal necrolysis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- Affiliated to a social security scheme
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Créteil, France
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Créteil, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.