NCT02993809Unknown1 期
Autologous Transplantation of BM-ECs With Platelet-Rich Plasma Extract for the Treatment of Critical Limb Ischemia
South China Research Center for Stem Cell and Regenerative Medicine0 个研究点目标入组 40 人开始时间: 2018年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 主要终点
- Survival without major amputation
研究概览
简要总结
The intent of this clinical study is to evaluate the safety of the injection composed of autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE) for the treatment of critical limb ischemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Limb ischemia patients(e.g. arteriosclerosis obliterans,diabetic critical limb ischemia, thromboangitis obliterans)
- •18 Years to 80 Years (Adult, Senior);
- •Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ;
- •Patient meets at least one of the following diagnostic criteria for the index limb:
- •ABI<0.7mmHg
- •TcpO2 <40 mm Hg
- •Or, nonhealing ulcer due to local arterial compromise with no opportunity for revascularization;
- •Have no improvement after conservative treatment and are not suitable for surgical bypass surgery because no outflow tract of diseased vessel can be found by imaging;
- •Despite having good outflow artery, but the elderly and frail patients can also not tolerate revascularization or interventional surgery;
- •Unlikelihood of major amputation of the leg during the next 12 months;
- •Expected life span more than 2 years.
排除标准
- •Pregnant or lactating;
- •Diabetics with poorly controlled blood glucose levels (defined as HbA1c>7% and/or proliferative retinopathy);
- •Patients with decompensated cardiac, renal or liver disease;
- •Patients with confirmed malignant tumor;
- •Subjects are with serious heart, liver, kidney and lung failure or under poor general condition that are inability to undergo bone marrow harvesting and transplantation;
- •Known or suspected disease of the immune system or osteomyelitis;
- •Inability to sign informed consent form and to comply with the schedule of the study;
- •There has reason to suspect that the patient is forced to join the study;
- •Any other condition, in the opinion of the investigator, would render the patient unsuitable for the study.
结局指标
主要结局
Survival without major amputation
时间窗: 6 months after implantation
次要结局
- Perfusion rate in treated tissue by transcutaneous PO2 (TcPO2)(Within 6 months after implantation)
- wound stage(Within 6 months after implantation)
- Perfusion rate in treated tissue by measure of ankle-brachial index (ABI)(Within 6 months after implantation)
- Perfusion rate in treated tissue by digital subtraction angiography (DSA)(Within 6 months after implantation)
- Pain intensity(Within 6 months after implantation)
- wound size(Within 6 months after implantation)
- Thermography(Within 6 months after implantation)
研究者
相似试验
已完成
1 期
A Study to Evaluate Platelet Rich Plasma to Treat Vulvar Lichen SclerosusVulvar Lichen SclerosusNCT04967170Jennifer R. Arthurs30
Unknown
2 期
Use of Autologous Plasma Rich in Platelets and Extracellular Vesicles in the Surgical Treatment of Chronic Middle Ear InfectionsOtitis Media ChronicTympanic Membrane PerforationNCT04761562University Medical Centre Ljubljana100
Unknown
2 期
Bone Mesenchymal Stem Cell (BMSC) Transplantation in Liver Cirrhosis Via Portal VeinLiver CirrhosisNCT00993941Sun Yat-sen University60
已完成
1 期
Safety of Autologous Stem Cell Treatment for Traumatic Brain Injury in ChildrenTraumatic Brain InjuryNCT00254722The University of Texas Health Science Center, Houston10
Unknown
1 期
Biological Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisNCT02193893Pomeranian Medical University Szczecin50