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临床试验/JPRN-UMIN000005232
JPRN-UMIN000005232已完成2 期

Transplantation of autologous mononuclear cells in patients with critical limb ischemia (CLI) - MNC therapy in CLI patients

Regenerative Medicine Unit, Division of Vascular Regeneration Therapy, Institute of Biomedical Research and Innovation (IBRI)0 个研究点目标入组 5 人开始时间: 2011年3月10日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
5

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
20years-old 至 80years-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1) CLI within category 6 on the Rutherford's scale 2) Less than 3 months since success of bypass surgery, transluminal angioplasty and sympathectomy for the limb expected to be transplanted 3) Left ventricular ejection fraction< 25% 4) Patients with a history of severe side effects to apheresis 5) Patients with malignant tumor 6) Patients with diabetic proliferating retinopathy (new Fukuda classification Bii to BV) 7) Less than 3 months since last episode of unstable angina and myocardial/cerebral infarction 8) Patients with cirrhosis of the liver 9) Leukocytes exceeding 15,000/ micro L 10) Platelets less than 100,000/ micro L 11) Hemoglobin less than 8 g/dL 12) Patients with rest pain, ulcer or necrosis for reasons other than CLI (such as lumber spinal canal stenosis, arthropathy or vasculitis) 13) Patients who require major amputation regardless of whether revascularization is successful or not, because of exposure of the bone or tendon due to osteomyelitis, osteonecrosis, ulcer and soft tissue necrosis, or sepsis 14) Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period 15) Patients enrolled in any other clinical trial 16) Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.

研究者

发起方
Regenerative Medicine Unit, Division of Vascular Regeneration Therapy, Institute of Biomedical Research and Innovation (IBRI)

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