注册号: Registration number: |
ChiCTR-TNC-10001076 |
最近更新日期: Date of Last Refreshed on: |
2015-07-03 |
注册时间: Date of Registration: |
2010-10-15 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
菲立磁标记骨髓间充质干细胞移植后活体示踪的临床研究 |
Public title: |
In Vivo Tracking of Feridex Labeled Bone Marrow Mesenchymal Stem Cells after Transplantation |
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: |
菲立磁标记骨髓间充质干细胞移植后活体示踪的临床研究 |
Scientific title: |
In Vivo Tracking of Feridex Labeled Bone Marrow Mesenchymal Stem Cells after Transplantation |
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: |
代广辉 |
研究负责人: |
代广辉 |
Applicant: |
Guanghui Dai |
Study leader: |
Guanghui Dai |
申请注册联系人电话: Applicant telephone: |
+86 010 88246845 |
研究负责人电话: Study leader's telephone: |
+86 010 88246845 |
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: |
daig74@sina.com |
研究负责人电子邮件: Study leader's E-mail: |
daig74@sina.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: |
北京市海淀区永定路69号 |
研究负责人通讯地址: |
北京市海淀区永定路69号 |
Applicant address: |
69 Yongding Road, Haidian, Beijing |
Study leader's address: |
69 Yongding Road, Haidian, 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: |
中国人民武装警察部队总医院 |
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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: |
20100623 |
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: |
中国人民武装警察部队总医院医学伦理委员会 |
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Name of the ethic committee: |
The Medical Ethics Committee of The General Hospital of the Chinese Armed Police Force |
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伦理委员会批准日期: Date of approved by ethic committee: |
2010-09-25 | ||
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: |
中国人民武装警察部队总医院 |
Primary sponsor: |
General Hospital Of Chinese People's Armed Police Forces |
研究实施负责(组长)单位地址: |
北京市海淀区永定路69号 |
Primary sponsor's address: |
69 Yongding Road, Haidian, Beijing |
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: |
自筹资金 |
Source(s) of funding: |
Self-financing |
研究疾病: |
脑性瘫 |
Target disease: |
Cerebral palsy |
研究疾病代码: |
G80.901 |
Target disease code: |
G80.901 |
研究类型: |
观察性研究 |
Study type: |
Observational study |
研究所处阶段: |
探索性研究/预试验 |
Study phase: |
0 |
研究目的: |
通过核磁共振扫描检查,观察移植入人体内的骨髓间充质干细胞在中枢神经系统的存活、分布及迁徙等状况 |
Objectives of Study: |
Obeserving the survival,distribution and migration of grafted bone marrow stem cells (BMSCs) labeled with Feridex through MRI Scan in the central nervous system |
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: |
单臂 |
Study design: |
Single arm |
纳入标准: |
(1)签署知情同意书; (2)6月-12岁确诊为脑瘫的GMFCS评分IV-V级的患儿; (3) 家长自愿接受骨髓干细胞移植并接受随访。 |
Inclusion criteria |
1. Signed informed consent document; 2. Patients with CP were aged between 6 months to 12 years old; 3. Gross Motor Function Classification System (GMFCS) levels IV,V; 4. Their parents accepted voluntarily stem cell transplantation for their children and followed-up. |
排除标准: |
(1)高度过敏体质或者有严重过敏史者; (2)血清学检查如艾滋病、乙肝、梅毒阳性者等; (3)遗传代谢病; (4)肿瘤或造血系统疾病病史; (5) 既往癫痫病史。 |
Exclusion criteria: |
1. Have a history of severe allergic; 2. Serological tests such as AIDS, hepatitis B, syphilis, etc; 3. Hereditary metabolic diseases of nervous system; 4. Tumor or Hematological diseases. 5. No previous history of epilepsy |
研究实施时间: Study execute time: |
从From2010-06-01至To 2011-06-30 |
征募观察对象时间: Recruiting time: |
从From2010-09-01至To |
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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