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Mesenchymal stromal cells treatment in Lyell syndrome: A pilot phase 1-2 open trial (LYSYME)
EU CTIS ID: 2024-516404-42-00
What this study is testing
To evaluate the safety and the efficacy i.e., complete almost complete cutaneous re-epithelialization at D7 after infusion of 2×106/kg ASCs in SJS-TEN patients.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- For patients : Patient ≥18 and ≤ 75 years-old
- For donors : Written consent
- For donors : Affiliated to a social security scheme
- For patients : Admission ≤ 10 days after the index date (date of the first symptoms of the disease)
- For patients : Patient with confirmed SJS-TEN diagnosis hospitalized in the department of Dermatology or intensive care medicine
- For patients : 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)
You likely can't join if
- For patients : Pregnant or breastfeeding woman
- For donors : Treatment with extractive pituitary hormones (including growth hormones)
- For donors : Human dura mater transplant
- For patients : History of malignant disease within the past ten years and or presence of metastasis
- For donors : Surgical history of the central nervous system
- For donors : Dementia or neurological disease that may evoke subacute spongiform encephalopathy
See the full eligibility criteria
Who can join
- For patients : Patient ≥18 and ≤ 75 years-old
- For donors : Written consent
- For donors : Affiliated to a social security scheme
- For patients : Admission ≤ 10 days after the index date (date of the first symptoms of the disease)
- For patients : Patient with confirmed SJS-TEN diagnosis hospitalized in the department of Dermatology or intensive care medicine
- For patients : 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)
- For patients : 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 requirements
- For patients : Affiliated to a social security scheme
- For donors : Donor ≥ 18 and ≤ 55 years old
- For donors : Admission for a programmed plastic surgery of liposuction or aspiration in the abdominal wall under general anesthesia
- For donors : Health history questionnaire in appendix completed
What rules you out
- For patients : Pregnant or breastfeeding woman
- For donors : Treatment with extractive pituitary hormones (including growth hormones)
- For donors : Human dura mater transplant
- For patients : History of malignant disease within the past ten years and or presence of metastasis
- For donors : Surgical history of the central nervous system
- For donors : Dementia or neurological disease that may evoke subacute spongiform encephalopathy
- For donors : Family history as part of subacute spongiform encephalopathy
- For donors : Hematological malignancies
- For donors : Active or cured cancer
- For donors : System or connective tissue disease
- For donors : Active generalized infection (bacterial, viral, parasitic, tuberculosis, leprosy...)
- For patients : Patient deprived of liberty by a judicial or administrative decision or under the protection of justice
- For donors : Multiple adenopathy, splenomegaly, hepatomegaly at clinical examination
- For donors : Icterus
- For donors : Chemotherapy history, irradiation
- For patients : Positive serology for HIV
- For donors : Long-term systemic steroids (duration > 30 days within the 5 past years or within 1 month before inclusion, at any dose)
- For patients : Active infection for hepatitis B or C
- For patients : Detection of Coronavirus SARS CoV-2 RNA on admission (positive RTPCR), if performed in the usual care
- For patients : Decompensated cardiac failure
- For patients : Uncontrolled epilepsia
- For patients : Previous history or allogenic bone marrow transplantation
- For patients : Any psychological, familial, sociological or geographical condition potentially hampering compliance with the research protocol and followup schedule
- For patients : Participation in other interventional drug research
- For donors : Authenticated risk factors for viral infections in the past 12 months : o Multiple sexual partners (donor or regular partner) o Intravenous addiction (donor or regular partner) o Accident of exposure to blood or derivatives suspected of being contaminated
- For donors : Topical steroids on abdominal wall within 1 month before inclusion
- For donors : Contraindication to general anesthesia
- For donors : Body mass index <18.5 or >30 kg/m2
- For donors : Active smoking
- For donors : Unbalanced diabetes or treated by insuline
- For donors : Donors who present a risk according to current health alerts and recommendations from ANSM, ABM and SECPROCH at the time of inclusion
- For donors : In addition, any donor patient presenting an exclusion criterion or any element considered to be clinically significant in appendix will not be included
- For patients : Patient under tutorship or curatorship
- For patients : Patient under psychiatric care according to art. L1121-6 CSP
- For donors : Positive viral serology: HIV, HBV (An anti HBc antibody isolated without detection of viral genome (HBV NAT) and HBsAg can be considered as acceptable), HCV, HEV, syphilis, HTLV, active infection with IgM+ for toxoplasmosis, EBV, CMV
- For donors : Detection of Coronavirus SARS CoV-2 RNA on screening (positive RTPCR), if performed in the usual care
- For donors : Deprived of freedom
- For donors : Significant comorbidities according to donor health history, if considered to be clinically significant by the investigator
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.