A

Phase 1

• Conditions: Patients: Adults diagnosed with SJS-TEN with at least 10% of body surface area involved.; MedDRA version: 20.0Level: LLTClassification code 10025166Term: Lyell syndromeSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-000308-12-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-28
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients:
- Patients aged from 18 to 75 years-old
- Admission less than 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)
- Written consent from patient or trustworthy person or legal representant or family member
- Affiliated to a social security scheme

Donors:
- Donors aged from 18 to 55 years old
- Admission for a programmed plastic surgery of liposuction or aspiration in the abdominal wall under general anesthesia
- Selection criteria according to stem cell donor health history questionnaire from Agence de la Biomédecine
- Written consent
- Affiliated to a social security scheme

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Patients:
- 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 or allogenic bone marrow transplantation
- Participation in other interventional drug research
- Patient deprived of freedom
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the research protocol and follow-up schedule

Donors:
- Positive viral serology (HBV, HCV, HIV, HEV, syphilis, HTLV, active infection with IgM+ for toxoplasmosis, EBV, CMV)
- Deprived of freedom
- Significant comorbidities according to donor health history or authenticated risk factors for viral infections in the past 12 months:
•Multiple sexual partners between the donor or his or her usual partner
•Intravenous addiction to the donor or regular partner
•Accident of exposure to blood or derivatives suspected of being contaminated
- Treatment with extractive pituitary hormones (including growth hormones)
- Human dura mater transplant
- Surgical history of the central nervous system
- Dementia or neurological disease that may evoke subacute spongiform encephalopathy
- Family history as part of subacute spongiform encephalopathy
- Hematological malignancies
- Active or cured cancer
- System disease
- Active generalized infection (viral, parasitic, tuberculosis, leprosy...)
- Multiple adenopathy, splenomegaly, hepatomegaly
- Icterus
- Chemotherapy history, irradiation
- Long-term steroids ( > 90 days)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified