JPRN-jRCTb050190082暂停未知
Therapeutic angiogenesis using bone marrow-derived mononuclear cells implantation for critical limb ischemiawith Buerger's disease - Therapeutic angiogenesis for critical limb ischemiawith Buerger's disease
Matoba Satoaki0 个研究点目标入组 25 人开始时间: 2019年12月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 暂停
- 发起方
- 入组人数
- 25
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
- •Incorporate patients who satisfy 1) to 6).
- •1) Patients who are at least 20 years old and less than 80 years old at the time of obtaining written consent.
- •2) Sex does not matter.
- •3) Patients with obstructive thromboangiitis (Burger's disease) of Fontaine III-IV.
- •4) Patients whose affected skin tissue perfusion pressure (SPP) at enrollment is less than 30 mmHg.
- •5) Patients who were confirmed to have no recovery after receiving the standard medical treatment listed. (Including patients who may have amputation of the affected limbs.) (*) (*) Standard treatment included in insurance means drug therapy such as blood flow improving drug and anti-inflammatory analgesic, exercise therapy, sympathetic nerve It is a node block and revascularization such as percutaneous angioplasty and bypass surgery.
- •6) With regard to the benefits and disadvantages caused by receiving cell transplants, and the benefits and disadvantages resulting from not receiving cell transplants, the informed consent documents fully explain the patient's will Patients who have obtained written consent for study participation based on the need for understanding and consent of the family).
排除标准
- •1) Diseases, even if the procedure is suitable, informed consent can not be obtained from the patient, or if it is difficult to adapt to the patient's family requiring emotional consideration.
- •2) Life expectancy is considered to be less than one year due to other complications.
- •3) When diagnosed as a malignant tumor.
- •4) If you have ischemic heart disease and revascularization has not been performed.
- •5) Untreated with severe diabetic retinopathy.
- •6) If you have a serious infection.
- •7) If there is severe liver dysfunction or renal dysfunction (except for maintenance dialysis patients).
- •8) If there is a serious blood disease such as leukopenia, thrombocytopenia and severe anemia requiring blood transfusion.
- •9) If pregnant and pregnant, or lactating women.
- •10) Those who participated in clinical trials or clinical trials such as medicines or medical devices at the same time as this study or within 30 days before being included in this study.
- •11) If there are other serious acute or chronic medical or mental conditions or laboratory abnormalities, and there is a possibility that participation in the test may increase the risk or influence the interpretation of the test results.
- •12) In addition, when the study responsible (assignment) doctor judged that participation in this study was inappropriate.
- •13) At the time of obtaining consent, the person in charge of implementation or the investigator in charge of the study judged that it is necessary to immediately provide revascularization treatment at both sides or multiple sites in both severe ischemia limbs and multiple affected limbs (including upper and lower limbs). if you did this.
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