ISRCTN14054375进行中（未招募）3 期
Application of G-CSF mobilized autologous circulating hematopoietic stem/progenitor cells (CPC) for patients with diffuse coronary artery disease (CAD) who are non-candidates for coronary artery intervention: a phase III clinical trial for evaluation of efficacy
Chang Gung Memorial Hospital, Chang Gung Medical Foundation0 个研究点目标入组 96 人开始时间: 2018年6月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
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
- 性别
- All
入选标准
- •Age between 20-80 y/o, coronary syndrome, subjects with severe diffuse coronary artery disease who have been diagnosed by cardiac catheterization, not suitable for cardiac catheterization or surgical coronary artery bypass surgery after cardiac internist and surgeons evaluate, and receiving optimal medical therapy, including antiplatelet therapy (aspirin or clopidogrel), ACEI/ARB, beta-blocker, calcium channel blocker, nitrates, etc. The symptom of chest pain is still evaluated as Canadian Cardiovascular Society class II-IV Angina. LVEF =55 % examined by 3D echo (i.e. LVEF =60 % indicates normal. After stem cell treatment, the LVEF is improved up to 5 %, unchanged or continually deteriorated. Therefore, the criteria of enrollment of LVEF is =55 %). Patients are willing to accept the G-CSF mobilized autologous circulating hematopoietic stem/progenitor cells (CPC) treatment through cardiac catheterization, and are willing to join this study follow-up.
- •The severe diffuse coronary artery disease is defined as follows:
- •1. Clinical symptoms of angina (Canadian Cardiovascular Society class II-IV)
- •2. Tl-201 scan presents reversible ischemic changes (results should be adopted within 6 months)
- •3. Highly diffuse vascular lesions show in angiography results (continuous normal segmental vessels length no longer than 10 mm), and the degree of stenosis more than 75% (results can be adopted within 6 months)
- •4. Due to vascular occlusion showed diffuse and too small, not to be suitable for PCI (angioplasty nowhere to be implemented) or CABG (which can be accessed at no normal blood vessels) analyzed by PCI and CABG experts. The vessel must be severe diffuse stenosis (unsuitable for CABG)
排除标准
- •1. Age <20 y/o or >80 y/o
- •2. Pregnant or breastfeeding women
- •3. No adventitious agents, ex. HIV infection, HBV and HCV carriers (HBsAg+ or anti-HCV +) (subjects without examination of HIV, HBV and HCV are excluded)
- •4. Myocardial infarction within 3 months, stent placement within 3 months
- •5. Severe aortic or mitral stenosis
- •6. Asthma and not suitable for cardiac catheterization treatment (including NYHA functional class IV)
- •7. Malignant or hematologic disease. Severe disease with life span less than one year
- •8. Chronic kidney disease (CCr <20 ml/min) and patients receiving dialysis
- •9. Under immunosuppressive medications
- •10. Autoimmune diseases
- •11. Contraindication to G-CSF
- •12. The subject previously received cell therapy
- •13. Participating in another clinical study and planning to participate in another clinical study during the course of this study
研究者
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