Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Treadmill Walking Distance
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Buerger's disease.
详细描述
Buerger's disease, also known as thromboangiitis obliterans, is a rare disorder that, in most cases, affects young or middle-aged male cigarette smokers. It is characterized by narrowing or blockage (occlusion) of the veins and arteries of the extremities, resulting in reduced blood flow to these areas (peripheral vascular disease). The exact cause of Buerger's disease is not known; however, most affected individuals are heavy tobacco users.
This drug is an autologous cell treatment for necrosis in the legs of patients with Beurger's diseases to improve symptoms through vascular regeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who understand and sign the consent form for this study.
- •Age :20-80, males and females
- •Patients at least 6 months after Buerger's disease
- •Patients with a luminal stenosis of more than 50% on angiography
- •Rutherford class II-4, III-5 or III-6
- •Subjects not eligible to undergo a revascularization or vascular bypass graft
- •Patients who can't treat with traditional medication and need a arthroplasty.
- •Patients whose lesion is 2~6 cm2 in size
- •Duration of pain over Grade 4(11-point numeric scale) : > 4 months
排除标准
- •Subjects who cannot survive more than 6 months with critical other complications.
- •Patient with well-known active malignant tumor.
- •Patients who exceed normal reference values from following test : PAP smear screening, chest X-ray, PSA, mammogram, occult blood test
- •Patients in need of a immediate amputation and have a potentially life-threatening complications of critical ischemia
- •Patients with uncontrolled iliac artery obstruction of targeted areas.
- •Condition with targeted lower limb that have widespread necrosis or in need of amputation.
- •End-stage renal failure patients who depend on hemodialysis
- •Patients with uncontrolled diabetes mellitus (HbA1c > 10%).
- •Treatment with immunosuppressant (prednisone > 5mg/day).
- •Treatment with a anti-inflammatory drugs within 1 weeks prior to enrollment.
- •Women who are pregnant or breast feeding or planning to become pregnant during the study.
- •Subjects who have cerebrovascular accident within 6 months prior to inclusion in the study.
- •Patients with acute myocardial infarction, angina pectoris.
- •Subjects who had been underwent a cardiovascular surgery such as carotid endarterectomy, arterial aneurysm, bypass surgery and coronary bypass surgery within 3 months prior to inclusion in the study.
- •Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
- •Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
研究组 & 干预措施
RNL-Vascostem®
drug name and ingredients : RNL-Vascostem[Autologous adipose tissue derived mesenchymal stem cells] dosage : Intramuscular infusion, 5 x 10e6 cells/kg
干预措施: RNL-Vascostem® (Biological)
结局指标
主要结局
Treadmill Walking Distance
时间窗: 24 weeks
Improvement in TWD(Treadmill Walking Distance)
次要结局
- VAS(Visual Analog Scale)(24 weeks)
- Angiography(24 weeks)
- Arterial Brachial Pressure Index, ABPI(24 weeks)
- Toe-Brachial Pressure Index, TBPI(24 weeks)
- Transcutaneous oxygen pressure, TcPO2(24 weeks)
- Pain Free Walking Distance, PFWD(24 weeks)
- Safety Evaluation(24 weeks)
- Laser Doppler(24 weeks)
- dose and frequency in use of a analgesic medicine(24 weeks)