Islet Allotransplantation for Type 1 Diabetic Patients
研究概览
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510260
- 招聘中
- The Second Affiliated Hospital of Guangzhou Medical University
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接触：
- ping Xue, PhD
- 电话号码：+86-020-34153080
- 邮箱：gyeygdwk@qq.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Clinical diagnosis of type 1 diabetes 18 <Age <70 years Evolution of diabetes for more than 5 years Regular patient follow-up (> or equal to 2 visits per year from the same diabetologist) ABO compatibility with the donor Cross match negative Anti-HLA antibodies (class I and / or class II) detected by lymphocytotoxicity <20% Accepting patients effective contraception during the study period
Exclusion Criteria:
Clinical diagnosis of type 2 diabetes BMI > 28 Need insulin < 28 U per day Pregnancy, lactation Psychiatric Disorders Inability to communicate or cooperate with the investigator Lack of therapeutic compliance, including HbA1C > 12% Chronic liver disease Proliferative retinopathy unstabilized History of cancer, whatever the date, except for basal or squamous cell skin cancers over 1 year.
Systemic infection Chronic high risk of requiring corticosteroids Need for long-term corticosteroid, outside that specified in renal transplantation, the patients will be weaned before transplantation Anticoagulant vitamin K or antiplatelet treatments Platelets < 100 giga/L and/or neutrophils <1.5 giga/L Chronic intoxication by alcohol, tobacco, or other substance (abstinence > 6 months required) Active infection by hepatitis B, hepatitis C and HIV, HTLV-1-HTLV2 Ascites
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学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Allogeneic transplantation of human islet
Each subject may receive 1-3 transplantations of allogeneic human islets we will inject the least dose of 3,000 IEQ/kg body weight of the recipient.
Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml.
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Allogeneic transplantation of intrahepatic islet is one of the effective methods for diabetic therapy
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Obtaining an improvement in glycemic control
大体时间：nine months after first and last islet transplants
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The proportion of subjects with an HbA1c ≤ 6.5% and free of severe hypoglycemic events
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nine months after first and last islet transplants
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normal glycemic control without insulin
大体时间：3 months after graf
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A fasting glucose (> 8 hours) less than 1.25 g/L and a 2 hours glucose after oral intake of 75g of glucose, less than 2 g/L in a patient without insulin for at least 15 consecutive days during the the first 6 months
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3 months after graf
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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insulin independence
大体时间：One year after the last transplant
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insulin independence
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One year after the last transplant
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Hypoglycemic episodes by HYPO score
大体时间：3 months after transplantation
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Hypoglycemic episodes by HYPO score
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3 months after transplantation
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degenerative complications of diabetes
大体时间：18 months after transplantation
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degenerative complications of diabetes
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18 months after transplantation
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合作者和调查者
调查人员
- 首席研究员：ping Xue, PhD、Second Affiliated Hospital of Guangzhou Medical University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Y-03
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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