注册号: Registration number: |
ChiCTR-TRC-12002868 |
最近更新日期: Date of Last Refreshed on: |
2015-12-29 |
注册时间: Date of Registration: |
2012-12-23 |
注册号状态: |
补注册 |
Registration Status: |
Retrospective registration |
注册题目: |
脐带间充质干细胞移植与常规抗糖尿病治疗对2型糖尿病的疗效对比分析 |
Public title: |
Comparative analysis on the curative effect between umbilical cord mesenchymal stem cell transplantation and anti-diabetic treatment |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
脐带间充质干细胞移植与常规抗糖尿病治疗对2型糖尿病的疗效对比分析 |
Scientific title: |
Comparative analysis on the curative effect between umbilical cord mesenchymal stem cell transplantation and anti-diabetic treatment |
研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
申请注册联系人: |
刘学彬 |
研究负责人: |
安沂华 |
Applicant: |
Xuebin Liu |
Study leader: |
Yihua an |
申请注册联系人电话: Applicant telephone: |
+86 010-57976849 |
研究负责人电话: Study leader's telephone: |
+86 010-57976848 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
liuxb912@163.com |
研究负责人电子邮件: Study leader's E-mail: |
riveran@163.com |
申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
北京海淀区永定路69号 细胞移植科 |
研究负责人通讯地址: |
北京海淀区永定路69号 细胞移植科 |
Applicant address: |
Department of Cell transplantation, 69 Yongding Road, Haidian District, Beijing |
Study leader's address: |
Department of Cell transplantation, 69 Yongding Road, Haidian District, Beijing |
申请注册联系人邮政编码: Applicant postcode: |
研究负责人邮政编码: Study leader's postcode: |
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申请人所在单位: |
武警总医院 |
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Applicant's institution: |
General Hospital of Chinese People's Armed Police Forces |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
09132011 |
伦理委员会批件附件: Approved file of Ethical Committee: |
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批准本研究的伦理委员会名称: |
武警总医院伦理委员会 |
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Name of the ethic committee: |
Ethics committee of General Hospital of Chinese People's Armed Police Forces |
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伦理委员会批准日期: Date of approved by ethic committee: |
2011-10-10 | ||
伦理委员会联系人: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
研究实施负责(组长)单位: |
武警总医院 |
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Primary sponsor: |
General Hospital of Chinese People's Armed Police Forces |
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研究实施负责(组长)单位地址: |
北京海淀区永定路69号 |
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Primary sponsor's address: |
69 Yongding Road, Haidian District, Beijing |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
院内课题 |
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Source(s) of funding: |
Armed Police General Hospital Funding |
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研究疾病: |
2型糖尿病 |
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Target disease: |
Type 2 Diabetes |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
II期临床试验 | ||||||||||||||||||||||
Study phase: |
2 |
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研究目的: |
观察脐带间充质干细胞移植治疗与常规抗糖尿病治疗对2型糖尿病的疗效对比分析 |
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Objectives of Study: |
Comparative analysis on the curative effect between umbilical cord mesenchymal stem cell transplantation and anti-diabetic treatment |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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纳入标准: |
1、年龄在18-70岁,2型糖尿病患者,男女不限; 2、目前现有的抗糖尿病治疗(包括药物和胰岛素)血糖控制不佳已经三个月,无急性并发症倾向; 3、2型糖尿病诊断明确 4、空腹血糖≥7.0 mmol/L ,糖化血红蛋白≥7% 5、心肝肾等脏器功能正常,能耐受介入等手术。 |
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Inclusion criteria |
The inclusion criteria included the following: the patients were between the ages of 18 and 70 years, male or female; they had poor glycemic control with recent anti-diabetic therapies, including drugs and/or insulin injection for at least three months; they had a negative result in testing for the glutamic acid decarboxylase antibody; they had not been pregnant or nursing; they had a fasting blood glucose (FBG) level >=7.0 mmol/L and HbA1c>=7%; and they had a good organic sufficiency, including heart, liver, kidney and lung, to receive interventional therapy. |
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排除标准: |
1、有急慢性感染;2、有过肿瘤的;3、免疫性疾病;4、妊娠糖尿病;5、心、肝、肾功能不全;6、出血性疾病、凝血异常、造影剂过敏或正在应用抗凝药物;7、其他内分泌及代谢性疾病。 |
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Exclusion criteria: |
acute or chronic infections; any malignancies; hematological diseases or coagulopathy; known immunosuppressive disease (e.g., acquired immunodeficiency); acute or chronic pancreatitis; and a history of thoracic or abdominal aorta diseases |
研究实施时间: Study execute time: |
从From2011-06-01至To 2013-05-01 |
征募观察对象时间: Recruiting time: |
从From2011-06-01至To 2012-02-17 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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