EUCTR2020-000308-12-FR进行中（未招募）1 期
« Mesenchymal stromal cells treatment in Lyell syndrome: A pilot phase 1-2 open trial” - LYSYME
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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 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
排除标准
- •- 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
- •- 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
- •- Chemotherapy history, irradiation
- •- Long-term steroids ( > 90 days)
研究者
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