KCT0000194招募中未知
The Safety of Human Cord Blood-derived Mesenchymal Stem Cells Therapy in Patients with Peripheral Arterial Occlusive Disease:Phase 1 Clinical Study
Adult Stem Cell Research Center0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1) Among the patients who has Peripheral arterial occlusive disease caused by Buerger's disease and arteriosclerosis and at the same time their ABI (resting ankle-brachial index) is lower than 0.9 follow by hemodynamical definition.
- •(1) Rutherford’s (Fontaine’s stages IIb, III, IV) 3, 4, 5, and 6 (reference 12) patient who has at least 3months claudification or pain during a rest or gangrene or ulcer with irrespective period.
- •(but, patient who does not get better with medication and improvement of life style during 3months will be a candidate for Category 3)
- •(2) patient who is Inapplicable by Bypass surgery or percutaneous transluminal angioplasty;
- •In case of patients with bypass surgery or percutaneous transluminal angioplasty cannot be applied; By doctors from Vascular surgery, cardiovascular medicine, and department of radiology determines bypass surgy and percutaneous transluminal angioplasty is not applicable through reffering system.
- •2) Person who agree to the agreement by themselves by fully explained about purpose, content and charateristic of trial medicine before participate
排除标准
- •(1) Under 18
- •(2) Medical history of allergy or anaphylatic shock
- •(3) Medical history of Autoimmune disease
- •(rheumatoid arthritis, systemic lupus erythematosus, ....)or Hypercoagulated disease
- •(4) Having the bypass surgery or angioplasty of artery or aorta within first
- •two months of visit
- •(5) Medical history of being treated with other cell therapy of gene therapy
- •(6) Having a Heart failure of NYHA functional classification III & IV (reference 13)
- •(7) Having unstable angina
- •(8) Medical history of acute ST-segment elevation with myocardial infarction within
- •a first month of visit
- •(9) Medical history of transient ischemic attack or stroke within a first month of visit
- •(10) Severe valvular heart disease
- •(11) Uncontrolled diabetes (HbA1c > 8%)
- •(12) Renal failure (creatinine > 2.5)
- •(13) Medical history of having malignant tumor or being treated with radiation therapy or chemotherapy within five years
- •(14) Pregnant or lactating or possible pregnancy women who is free to medically
- •accepted method of birth control
- •(15) Having cognitive dysfunction and walking disability
- •(16) Having infectious disease
- •(17) Severe disease patient who might die during follow-up period because of their
- •one year life expectancy
- •(18) WBC < 4,000 or WBC > 15,000
- •(19) AST (GOT) > 100 or ALT (GPT) > 100
- •(20) Having gait disturbance by neurology cause
- •(21) Disqualified as a suitable subjest by tester
- •(22) Uncontrolled hypertension
- •(23) Currently receiving immunosuppressive therapy or chemical therapy
- •(24) Hematodyscrasia patient with hemorragic diathresis
- •(25) Participated in other clinical trials
- •(26) Patient with Hb<10 and thrombocyte<100,000
研究者
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