Pilot Study of Intravenous Adipose Derived Mesenchymal Stromal Cells for Treating Lyell Syndrome Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in Adults Aged 18 to 75

What this Trial Is About

Researchers are investigating the use of mesenchymal stromal cells MSCs as a new treatment for Stevens-Johnson syndrome SJS and toxic epidermal necrolysis TEN, which are rare, severe skin reactions usually caused by drugs. MSCs have shown promise in healing various conditions due to their ability to modulate the immune system and promote tissue repair, making them a potential strategy to improve healing and reduce complications in SJS and TEN. The study involves giving patients a single intravenous injection of adipose-derived stromal cells at a dose of 2 million cells per kilogram of body weight, administered within three days after hospital admission. This pilot Phase 1-2 open trial focuses on evaluating the safety and effectiveness of this treatment for patients hospitalized with confirmed SJS-TEN. The infusion is given once at day 0, and patients are monitored closely after treatment. Participants will be followed to assess safety by observing any adverse effects by day 10 and to measure the rate of skin healing by day 7 after the infusion. Additional evaluations include monitoring hospital stay duration, mucous membrane healing, immune response, infection rates, and tissue regeneration up to 12 months after treatment. The study also includes laboratory tests and skin biopsies to better understand treatment effects and long-term outcomes.

LYell SYndrome MEsenchymal Stromal Cells Treatment