注册号: Registration number: |
ChiCTR1800014998 |
最近更新日期: Date of Last Refreshed on: |
2018-02-27 |
注册时间: Date of Registration: |
2018-02-27 |
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(hucMSCs)治疗急性呼吸窘迫综合征(ARDS)的探索性研究 |
Public title: |
Human umbilcal cord derived mesenchymal stem cells therapy in acute respiratory distress syndrome: a pilot study |
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(hucMSCs)治疗急性呼吸窘迫综合征(ARDS)的探索性研究 |
Scientific title: |
Human umbilcal cord derived mesenchymal stem cells therapy in acute respiratory distress syndrome: a pilot study |
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: |
吕海金 |
研究负责人: |
吕海金 |
Applicant: |
Haijin Lv |
Study leader: |
Haijin Lv |
申请注册联系人电话: Applicant telephone: |
+86 020 85252673 |
研究负责人电话: Study leader's telephone: |
+86 020 85252673 |
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: |
haijinlv@163.com |
研究负责人电子邮件: Study leader's E-mail: |
haijinlv@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: |
广州市天河区天河路600号 |
研究负责人通讯地址: |
广州市天河区天河路600号 |
Applicant address: |
600 Tianhe Road, Tianhe District, Guangzhou, Guangdong, China |
Study leader's address: |
600 Tianhe Road, Tianhe District, Guangzhou, Guangdong, 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: |
中山大学附属第三医院 |
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Applicant's institution: |
The Third Affiliated Hospital, Sun Yat-Sen University |
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: |
[2017]38 |
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: |
中山大学附属第三医院干细胞临床研究伦理委员会 |
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Name of the ethic committee: |
Ethic committee for stem cells clinical trail of the third affiliated hospital of Sun Yat-Sen University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2017-11-30 | ||
伦理委员会联系人: |
刘畅 |
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Contact Name of the ethic committee: |
Chang Liu |
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伦理委员会联系地址: |
广州市天河区天河路600号 |
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Contact Address of the ethic committee: |
600 Tianhe Road, Tianhe District, Guangzhou, Guangdong, China |
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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: |
中山大学附属第三医院 |
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Primary sponsor: |
The Third Affiliated Hospital, Sun Yat-Sen University |
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研究实施负责(组长)单位地址: |
广州市天河区天河路600号 |
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Primary sponsor's address: |
600 Tianhe Road, Tianhe District, Guangzhou, Guangdong, 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: |
中山大学附属第三医院临床研究计划 |
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Source(s) of funding: |
The Third Affiliated Hospital of Sun Yat-Sen University,Clinical Research Program |
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研究疾病: |
急性呼吸窘迫综合征 |
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Target disease: |
acute respiratory distress syndrome |
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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: |
探索性研究/预试验 | ||||||||||||||||||||||
Study phase: |
0 |
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研究目的: |
探索人脐带来源的间充质干细胞治疗成人中重度急性呼吸窘迫综合征的安全性 |
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Objectives of Study: |
To investigate safety of human umbilical cord derived mesenchymal stem cells therapy in moderate or severe acute respiratory ditress syndrome in adults |
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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≥18岁 2.同时满足以下条件: (1)有创机械通气伴有中重度ARDS,即OI(PaO2/FiO2)<200;(2)PEEP需求≥8cmH2O;(3)X线胸片呈双肺浸润影;(4)发病1周内;(5)经过肺保护性通气、肺复张、液体保守治疗后无改善的 |
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Inclusion criteria |
1. Aged≥18 years old; 2. Including all the criteria: (1) Invasive ventilation, OI(PaO2/FiO2)<200; (2) PEEP≥8cmH2O; (3) Bilateral inflitration of lung in X-ray or CT; (4) In 1 week after onset; (5) Still OI<200 after protective ventilation or conservative fluid management. |
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排除标准: |
(1)恶性肿瘤; (2)左心衰肺水肿; (3)X线提示>50%单侧肺不张; (4)妊娠、哺乳期或围产期; (5)既往有严重终末期肺病; (6)APACHEII或SOFA评分预测死亡风险>80%的患者; (7)肝衰竭MELD评分>40分; (8)III或IV级肺动脉高压; (9)未监测或无计划监测有创血压和中心静脉压患者; (10)有深静脉血栓或近3个月有肺栓塞病史; (11)严重脑疝; (12)ARDS发病超过96h |
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Exclusion criteria: |
(1) Any malignant disease; (2) Cardiogenic pulmonary edema; (3) Over 50% atelectasis either lung lobe in X-ray; (4) Pregnancy or perinatal or lactation; (5) Previous end stage respiratory disease; (6) More than 3 organs failure; (7) Liver failure with MELD score>40; (8) Stage III or IV pulmonary hypertension; (9) None invasive arterial and central venous catheter; (10) Concurrent deep venous thrombus or pulmonary embolism in 3 months; (11) Cerebral hernia; (12) More than 96 hours after ARDS onset. |
研究实施时间: Study execute time: |
从From2018-03-01至To 2019-12-31 |
征募观察对象时间: Recruiting time: |
从From2018-03-01至To 2019-11-30 |
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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