EUCTR2020-002936-55-CZ进行中（未招募）1 期
Safety and Efficacy of Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells in Patients with Epidermolysis Bullosa: Clinical Trial Phase I/II - MSC-EB
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
- •1) Age > 1 year (incl.)
- •2) Clinical diagnosis of hereditary EB supported by histological diagnosis (electron microscopy, immunofluorescence antigen mapping) and DNA analysis
- •3) The extent of the disease is at least 10% of the body surface
- •4) Participants in a clinical trial of childbearing potential must agree to the use of prescribed contraceptive methods for the duration of the clinical study and for at least 6 months following the last dose of the study medication:
- •a) Women - Proper use of a highly reliable method of contraception, ie combined hormonal contraception (in oral, vaginal or transdermal dosage form), gestagen hormonal contraception associated with ovulation inhibition (in oral or injectable dosage form), non-hormonal intrauterine device or intrauterine device releasing hormones, or the presence of bilateral tubal occlusion, a partner's vasectomy, or adherence to sexual abstinence as part of the patient's normal lifestyle.
- •b) Men - Adherence to sexual abstinence or the use of an adequate contraceptive method (ie condom) in case of sexual intercourse.
- •5) Willingness and ability to adhere to restrictions in the care of study lesions and to adhere to the schedule of visits and examinations during the course of the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 11
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Systemic infection or sepsis 7 days before MSC administration
- •2) Treatment with blood transfusion (erythrocyte concentrate or whole blood transfusion) 7 days before MSC administration
- •3) Clinical signs of infection in the study lesions 7 days before MSC administration
- •4) Inability to tolerate repeated skin injections (especially in pediatric patients)
- •5) History of basal cell or squamous cell carcinoma of the skin in the last 5 years
- •6) History of other malignancies of any type at any time during life
- •7) Severe lung disease that requires home oxygenation
- •8) Severe kidney or liver disease
- •9) Dilatation cardiomyopathy
- •10) Life expectancy less than 90 days
- •11) Severe immune response to allogeneic human cells
- •12) Other severe somatic or psychiatric illnesses that are not adequately controlled and, in the opinion of the investigator, would not allow the study protocol to be followed
- •13) Previous administration of a medicinal product in a clinical trial in the 30 days or 5 elimination half-lives (whichever is longer) before the enrolment to this trial (applies to clinical investigations of medical devices, as well)
- •14) Pregnancy or breastfeeding
- •15) Allergy/hypersensitivity to any component of Hypotermosol solution
研究者
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