LYell SYndrome MEsenchymal Stromal Cells Treatment

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jan 12, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment using mesenchymal stromal cells (MSCs) for patients suffering from Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These are serious skin conditions that can occur as a severe reaction to certain medications. Currently, there are no proven effective treatments to help patients heal from these conditions, and MSC therapy might offer a promising new option. MSCs are special cells that can help reduce inflammation and promote healing in the skin, making them a potential game-changer for patients with SJS and TEN.

To participate in this trial, individuals must be between 18 and 75 years old and have been diagnosed with SJS or TEN within the last 10 days. They should also have a significant area of their skin affected by the condition. Participants will need to provide consent, either themselves or through a family member. It’s important to note that certain people, such as those who are pregnant, have specific infections, or other serious health issues, will not be eligible for this study. Those who join the trial can expect close monitoring and support as they receive this experimental treatment aimed at improving their skin healing and overall health.

Gender

ALL

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