JPRN-jRCT2090220022已完成Unknown
Vascular regeneration therapy by transplantation of autologous peripheral blood CD34+ cells in patients with chronic critical limb ischemia - TRIASO0704
Atsuhiko Kawamoto0 个研究点目标入组 11 人开始时间: 2008年9月25日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1) Patients with infra-inguinal atherosclerosis with a stenosis (>70%), or occlusion (100%) of a major vessel in the affected limb(s) (demonstrated by diagnostic angiography) of one or more of the following arteries: superficial femoral, popliteal, or one or more infrapopliteal arteries.
- •2) At least 6 months since the onset of CLI (Chronic PAD)
- •3) Patients whose Rutherford's category is 4 or 5.
- •4) Patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/ restenosis following the traditional revascularization.
- •5) Age is between 20 and 80.
- •6) Patients who can give informed consent themselves in writing.
排除标准
- •1) Patients whose Rutherford's category is 6.
- •2) Patients who have had successful aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 3 months preceding screening.
- •3) Patients whose left ventricular ejection fraction by echocardiography < 25%
- •4) Patients with a history of severe allergic reactions or side effects to G-CSF preparations, apheresis or Isolex-relating reagents.
- •5) Patients with a history of allergic reactions or side effects to mouse, rat or bovine-derived proteins.
- •6) Patients with malignant tumor or a history of malignant tumor within 5 years.
- •7) Patients with diabetic proliferating retinopathy (new Fukuda classification BII to BV).
- •8) Less than 3 months since last episode of unstable angina or myocardial/cerebral infarction.
- •9) Patients with end stage renal disease on maintenance hemodialysis.
- •10) Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
- •11) Patients with autoimmune disease.
- •12) Patients who cannot discontinue Warfarin.
- •13) Patients with cirrhosis of the liver.
- •14) Patients currently suffering from or having a history of interstitial pneumonitis.
- •15) Patients with cerebral aneurysm indicative for surgical/ endovascular treatment by neurosurgeon.
- •16) Leukocytes less than 4,000/mcL or exceeding 15,000/mcL.
- •17) Platelets less than 100,000/mcL.
- •18) Hemoglobin less than 8 g/dL.
- •19) AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
- •20) Patients for whom abdominal CT or ultrasonography reveals splenomegaly.
- •21) Patients with rest pain or ulcer/ gangrene in the legs due to neural, joint or autoimmune diseases except PAD and Buerger disease.
- •22) Patients for whom major amputation of the lower extremity is indicated because of the severity of the tissue damage and functional aspects after amputation.
- •23) Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study
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