注册号: Registration number: |
ChiCTR-ONC-16008770 |
最近更新日期: Date of Last Refreshed on: |
2018-02-07 |
注册时间: Date of Registration: |
2016-07-03 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
人脐带间充质干细胞(hUC-MSCs)移植治疗类风湿关节炎(RA)的有效性及安全性评价研究 |
Public title: |
Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis (RA) |
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: |
人脐带间充质干细胞(hUC-MSCs)移植治疗类风湿关节炎(RA)的有效性及安全性评价研究 |
Scientific title: |
Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis (RA) |
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: |
杨奕 |
研究负责人: |
徐祥 |
Applicant: |
Yi Yang |
Study leader: |
Xiang Xu |
申请注册联系人电话: Applicant telephone: |
+86 18502389013 |
研究负责人电话: Study leader's telephone: |
+86 13637843870 |
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: |
yangyilyx@163.com |
研究负责人电子邮件: Study leader's E-mail: |
xiangxu@ymail.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: |
重庆市渝中区长江支路10号 |
研究负责人通讯地址: |
重庆市渝中区长江支路10号 |
Applicant address: |
10 Changjiang Branch Road, Chongqing, China |
Study leader's address: |
10 Changjiang Branch Road, Chongqing, China |
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: |
第三军医大学大坪医院风湿免疫科 |
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Applicant's institution: |
Department of Rheumatology and Immunology, Daping Hospital, Third Military Medical University, Chongqing |
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: |
201712 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
批准本研究的伦理委员会名称: |
第三军医大学第三附属医院伦理委员会 |
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Name of the ethic committee: |
The Ethics Committee of The Third Affiliated Hospital of The Third Military Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2016-03-06 | ||
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: |
第三军医大学大坪医院野战外科研究所 |
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Primary sponsor: |
Research Institute of Surgery, Daping Hospital, Third Military Medical University, Chongqing |
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研究实施负责(组长)单位地址: |
重庆市渝中区长江支路10号 |
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Primary sponsor's address: |
10 Changjiang Branch Road, Chongqing, China |
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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: |
自筹 |
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Source(s) of funding: |
self-financed |
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研究疾病: |
类风湿关节炎 |
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Target disease: |
rheumatoid arthritis |
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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: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
治疗新技术临床试验 | ||||||||||||||||||||||
Study phase: |
New Treatment Measure Clinical Study |
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研究目的: |
探讨干细胞治疗类风湿关节炎的新策略。 |
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Objectives of Study: |
To discuss a new strategy of stem cells to treat rheumatoid arthritis. |
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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: |
非随机对照试验 |
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Study design: |
Non randomized control |
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纳入标准: |
1.签署知情同意书者,患者及家属依从性好 ; 2.年龄在18-65岁的类风湿关节炎病人 ; 3. 所有患者均符合年美国风湿病学会(ACR1987)RA分类标准; 4.满足激素依赖或正规使用过甲氨喋呤/来氟米特/硫酸羟氯喹/柳氮磺吡啶/和或至少一种TNF-α抑制剂,仍高疾病活动度或不能耐受者。 |
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Inclusion criteria |
1. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital; 2. Patients of RA, to be aged 18 years to 65 years old; 3. All patients fulfilled the classification criteria (ACR21987) for rheumatoid arthritis; 4. All patients fulfilled hormone-dependent or through formal use of methotrexate / leflunomide / hydroxychloroquine sulfate / sulfasalazine and / or at least one kind of TNF-α inhibitor, is still high disease activity or can not be tolerated. |
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排除标准: |
1.患者由于存在无法纠正的疾病,比如晚期肿瘤或者其它晚期疾病; 2.患者处于可预知的垂死状态; 3.既往有骨髓,肺脏,肝脏,胰腺或小肠移植病史; 4.严重的心脏和肺衰竭,或其他重要器官的严重的不可逆损害或衰竭; 5.无法控制的感染; 6.在本试验开始前30天内参加了其他临床试验的志愿者; 7.怀孕或哺乳期妇女; 8.患者既往存在对生物制品过敏史,超敏反应或者其它严重反应; 9.HIV病毒感染合并最近一次CD4细胞计数≤50/mm3; 10. 病毒性肝炎。 |
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Exclusion criteria: |
1. Patients with uncorrected disease, such as advanced cancer or other terminal illness, the prospective survival period less than 28 days; 2. Patients in the foreseeable dying state; 3. Have the bone marrow, lungs, liver, pancreas, or small bowel transplantation history; 4. Have severe heart and lung failure, or irreversible damage or failure of other major organs; 5. Uncontrolled infection; 6. Patient participating or having participated in a clinical trial with another investigational drug Within 30 days before the start of this clinical trial; 7. Patient is pregnant or nursing; 8. History of patient is allergic to biological products; 9. HIV infected associated with the recent CD4+ cell count ≤50/mm3; 10. viral hepatitis. |
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研究实施时间: Study execute time: |
从From2016-05-01至To 2018-12-01 |
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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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无随机 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Non-randomized |
盲法: |
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Blinding: |
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原始数据公开时间: The time of sharing IPD: |
试验完成后6个月内公开/Within six months after the trial complete |
共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
发表在文章里 |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Published in the article |
数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
原始记录保存纸质版,实验结果数据发表在文章里 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Original records for print, the experiment result data published in the article |
数据管理委员会: Data Managemen Committee: |
暂未确定/Not yet |