Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
ID04711200

Mesenchymal Stromal Cells Treatment in Lyell Syndrome: A Pilot Phase 1-2 Open Trial

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-08-01

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Brief Title

LYell SYndrome MEsenchymal Stromal Cells Treatment

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 75 years old
  • Admission to hospital within 10 days after the first symptoms of the disease
  • Confirmed diagnosis of Stevens-Johnson syndrome or toxic epidermal necrolysis
  • At least 10% of detachable or detached body surface area within 10 days of symptom onset
  • Provided written informed consent before any study procedures
  • Affiliated to a social security scheme
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • History of malignant disease within the past ten years or presence of metastasis
  • Positive HIV serology
  • Active hepatitis B or C infection
  • Positive test for SARS-CoV-2 RNA on admission (if performed)
  • Decompensated heart failure
  • Uncontrolled epilepsy
  • Previous allogenic bone marrow transplantation
  • Participation in other interventional drug research
  • Legal restrictions such as being deprived of liberty or under judicial protection
  • Psychological, familial, sociological, or geographical conditions interfering with study compliance
  • Under tutorship or curatorship
  • Under psychiatric care according to law L1121-6 CSP

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single injection at Day 0

Participants receive a single intravenous injection of adipose derived stromal cells within three days of hospital admission.

1 treatment visit (in-person)

Follow-up

Duration - Up to 12 months

Participants are monitored for safety and efficacy outcomes including re-epithelialisation and immune response over the following month and up to 12 months.

Multiple visits including assessments at Day 5, Day 7, Day 10, Day 15, 1 month, and monthly up to 12 months

Trial Site Locations

Total: 1 location

1

Henri Mondor

Créteil, France

Actively Recruiting

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Research Team

S

Saskia Oro, MD

C

Charline Menanteau, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Stevens-Johnson syndrome and toxic epidermal necrolysis: assessment of medication risks with emphasis on recently marketed drugs. The EuroSCAR-study.

Maja Mockenhaupt, Cecile Viboud, Ariane Dunant...

https://pubmed.ncbi.nlm.nih.gov/17805350