注册号: Registration number: |
ChiCTR-ONC-10000985 |
最近更新日期: Date of Last Refreshed on: |
2015-06-17 |
注册时间: Date of Registration: |
2010-08-04 |
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治疗2型糖尿病 |
Public title: |
Umbilical cord mesenchymal stem cell transplantation for treatment of type2 diabetes |
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治疗2型糖尿病 |
Scientific title: |
Umbilical cord mesenchymal stem cell transplantation for treatment of type2 diabetes |
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: |
郑培 |
研究负责人: |
安沂华 |
Applicant: |
Pei Zheng |
Study leader: |
Yihua An |
申请注册联系人电话: Applicant telephone: |
+86 010-88276849 |
研究负责人电话: Study leader's telephone: |
+86 010-88276849 |
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: |
zhengpei126@126.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 神经干细胞移植科 |
研究负责人通讯地址: |
北京海淀区永定路69号 神经干细胞移植科 |
Applicant address: |
Neural stem cell transplantation Division, 69 Yongding Road, Haidian District, Beijing |
Study leader's address: |
Neural stem cell transplantation Division, 69 Yongding Road, Haidian District, Beijing |
申请注册联系人邮政编码: Applicant postcode: |
100039 |
研究负责人邮政编码: Study leader's postcode: |
100039 |
申请人所在单位: |
武警总医院 |
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Applicant's institution: |
Armed Police General Hospital |
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: |
2010506 |
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: |
Armed Police General Hospital Ethics Committee |
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伦理委员会批准日期: Date of approved by ethic committee: |
2010-05-06 | ||
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: |
Armed Police General Hospital |
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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 |
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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: |
武警总医院 |
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Source(s) of funding: |
Armed Police General Hospital |
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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: |
E11 |
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Target disease code: |
E11 |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
上市后药物 | ||||||||||||||||||||||
Study phase: |
4 |
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研究目的: |
观察分析脐带间充质干细胞移植治疗2型糖尿病的疗效 |
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Objectives of Study: |
To analyze the effect of umbilical cord mesenchymal stem cell transplantation in type 2 diabetes patient |
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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: |
连续入组 |
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Study design: |
Sequential |
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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、对目前治疗的血糖控制情况不满意,无急性并发症倾向; 3、2型糖尿病诊断明确 4、处于怀孕或哺乳婴儿的患者除外 5、空腹血糖≥7.0 mmol/L ,糖化血红蛋白≥7% 6、心肝肾等脏器功能正常,能耐受介入等手术。 |
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Inclusion criteria |
1. the patients were between the ages of 18 and 70 years, male or female; 2. they had poor blood control with recent anti-diabetic therapies, including drugs and/or insulin injection for at least three months; 3. they had a negative result in testing for the glutamic acid decarboxylase antibody; 4. they had not been pregnant or nursing; 5. they had a fasting blood glucose (FBG) level >=7.0 mmol/L and HbAc1>=7%; 6. 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恶性肿瘤;②严重心脏病或高血压;③急、慢性肾功能不全或肝功能衰竭;④严重哮喘或其他严重呼吸功能不全;⑤出血性疾病、凝血异常、造影剂过敏或正在应用抗凝药物;⑥先天性或获得性免疫缺陷疾病;⑦其他内分泌及代谢性疾病。 |
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Exclusion criteria: |
1. cancer; 2. serious heart disease or hypertension; 3. acute and chronic renal insufficiency or liver failure; 4. severe asthma or other severe respiratory insufficiency; 5. hemorrhagic disease, coagulopathy, contrast agent allergy or are being applied anticoagulant drugs; 6. congenital or acquired immunodeficiency diseases; 7. other endocrine and metabolic diseases. |
研究实施时间: Study execute time: |
从From2010-05-01至To 2011-05-01 |
征募观察对象时间: Recruiting time: |
从From2010-05-01至To 2010-12-31 |
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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