EUCTR2018-004563-31-FR进行中（未招募）1 期
Cell therapy in Critical Limb Ischemia by implantation of allogeneic umbilical cord-derived mesenchymal stem cells - CLI
Centre Hospitalier Universitaire de Reims0 个研究点目标入组 30 人开始时间: 2019年2月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- •1. The patient is suffering from critical limb ischemia and is being subject to a revascularization procedure, associated or not to minimally invasive surgery,
- •2. The patient (or his/her legal representative(s)) is capable to understand and comply with study requirements and to provide written informed consent prior to any study procedure for participation in the study and transmission of personal anonymized data, which signifies an agreement to enter the study and comply with the restrictions and requirements listed in the informed consent form (ICF).
- •3. Male or female patients aged =18 years at the time of signing the ICF.
- •4. A female patient is eligible to participate if she is of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) will be required to use one of the treatment methods that does not modify hemostasis parameters (eg chlormadinone acetate [Lutéran]) or must discontinue HRT to allow confirmation of post-menopausal status prior to being enrolled in the study.
- •5. Diabetic patients with an eye fundus examination of less than 3 months excluding proliferative retinopathy
- •6. Patient with a life expectancy >12 months
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1.Patients presenting a failure of the revascularization procedure
- •2.The patient has, or has a history of, any significant disease or disorder that would increase the risk for the patient if they were enrolled in the study or would affect study procedures or outcomes.
- •3.The patient is mentally or legally incapacitated.
- •4.Patient protected by law.
- •5.Patient who does not benefit from the national health insurance coverage.
- •6.The patient has been involved in a previous trial with the investigational product.
- •7.History of cancer excepting basocellular epithelioma during the past 5 years.
- •8.Patient necessitating chronic hemodialysis or creatinine clearance inferior to 30 mL/min.
- •9.History of stroke or myocardial infarction of less than 3 months.
- •10.Hemostasis disorder with contra-indication of intramuscular injections.
- •11.Patients receiving dual antiplatelet therapy that cannot be temporarily discontinued at least 4 days before and until 6 hours after cell implantation.
- •12.Patient receiving an antiplatelet therapy with an adenosine diphosphate receptor inhibitor (ADP/P2Y12 inhibitor) that cannot be temporarily discontinued at least 4 days before and until 6 hours after cell implantation.
- •13. Patient receiving an anticoagulant treatment that cannot be temporarily discontinued until 2 days after the study treatment injection.
- •14.Patients subject to a below the knee femoro-popliteal bypass procedure or to a femoro-tibial bypass procedure
- •15.Patients included in another therapeutic trial
研究者
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