2024-516614-37-00招募中2 期
Safety and efficacy of allogenic adipose tissue-derived mesenchymal stromal cells in patients with epidermolysis bullosa: Clinical trial phase I/II
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence of adverse events of special interest (AESI): severe local reaction at the injection site other than blistering, severe systemic allergic reaction at any time after MSC administration, severe systemic or local infectious complications at any time after MSC administration (combined primary safety endpoint)
研究概览
简要总结
The primary objective of the study is to assess the safety of human allogeneic mesenchymal stromal cells administered intradermally.
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age > 2 years (incl.)
- •Clinical diagnosis of hereditary EB supported by histological diagnosis (electron microscopy, immunofluorescence antigen mapping) and/or DNA analysis
- •The extent of the disease is at least 10% of the body surface
- •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.
- •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.
排除标准
- •Systemic infection or sepsis 7 days before MSC administration
- •Life expectancy less than 90 days
- •Severe immune response to allogeneic human cells
- •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
- •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)
- •Pregnancy or breastfeeding
- •Allergy/hypersensitivity to any component of Hypotermosol solution
- •Treatment with blood transfusion (erythrocyte concentrate or whole blood transfusion) 7 days before MSC administration
- •Clinical signs of infection in the study lesions 7 days before MSC administration
- •Inability to tolerate repeated skin injections (especially in pediatric patients)
- •History of basal cell or squamous cell carcinoma of the skin in the last 5 years
- •History of other malignancies of any type at any time during life
- •Severe lung disease that requires home oxygenation
- •Severe kidney or liver disease
- •Dilatation cardiomyopathy
结局指标
主要结局
Incidence of adverse events of special interest (AESI): severe local reaction at the injection site other than blistering, severe systemic allergic reaction at any time after MSC administration, severe systemic or local infectious complications at any time after MSC administration (combined primary safety endpoint)
Incidence of adverse events of special interest (AESI): severe local reaction at the injection site other than blistering, severe systemic allergic reaction at any time after MSC administration, severe systemic or local infectious complications at any time after MSC administration (combined primary safety endpoint)
次要结局
- Incidence, type, seriousness, intensity of AEs and their relation to study medication
- Percent change in the non-healed area of the area marked in the study active and control lesions from baseline
- Estimation of the total area of lesions on the patient's body (% of body surface area)
- Patient-reported outcomes (itching, ease of wound dressing change)
研究者
Regina Demlová
Scientific
Masarykova Univerzita
研究点 (1)
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