JPRN-UMIN000019395已完成未知
Clinical Enforcement of islet cell transplantation in our hospital - Clinical islet transplantation in Japanese patients with type 1 diabetes
agasaki University Hospital0 个研究点目标入组 10 人开始时间: 2015年10月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 20years-old 至 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.Body weight is greater than 80kg,or BMI is greater than 25kg/m2. 2.Insulin dose is over 0.8IU/kg/day day, or more than 55U/day. 3/The average value of HbA1C is more than 10.4% in the past year. 4.Patient has untreated proliferative diabetic retinopathy. 5.Systolic blood pressure is above 160mmHg or diastolic blood pressure is over 100mmHg. 6.eGFR is less than 60ml/min/1.73m2 (In case of islet transplantation alone). 7.Urine protein is more than 1g/day. 8.PRA(panel reactive antibody)is above 20%by flow cytometry. 9.Pregnancy test is positive or under the nursing. 10.Patient has following active infections. Hepatitis B or C, HIV, HTLV-I,or acid bacteriosis including tuberculosis. 11.Epstein-Barr IgG antibody is negative. 12.Patient has a history of invasive aspergillosis infection. 13.Patient has a history of cancer. However, completely resected squamous cell carcinoma or basal cell carcinoma of the skin is excluded. 14.Alchoholic or drug addict 15.Hemoglobin level is below normal limit; lymphopenia (<700/µL), neutropenia (<1,500/µL), or thrombocytopenia (platelets <100,000/µL). 16.Patient has a history of factor V deficiency. 17.Coagulation disorder or Anticoagulants are needed after transplantation. 18.Severe heart disease 1)Myocardial infarction in past past 6 months. 2)Ischemic heart failure that is diagnosed by cardiac function test in past one year. 3)Ejection fraction is less than 30%. 19.Liver function test values are sustained high AST,ALT(ALP, or total bilirubin values, continues more than 1.5 times the upper limit of normal) 20.Symptomatic cholelithiasis.
研究者
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