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人脐带间充质干细胞治疗乙型病毒性肝炎肝硬化失代偿期的临床研究
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注册号:

Registration number:

ChiCTR1900025427 

最近更新日期:

Date of Last Refreshed on:

2019-08-26 

注册时间:

Date of Registration:

2019-08-26 

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治疗乙型病毒性肝炎肝硬化失代偿期的临床研究 

Public title:

Clinical research for therapy of decompensated HBV-associated liver cirrhosis by human umbilical cord mesenchymal stem cells 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

人脐带间充质干细胞治疗乙型病毒性肝炎肝硬化失代偿期的临床研究 

Scientific title:

Clinical research for therapy of decompensated HBV-associated liver cirrhosis by human umbilical cord mesenchymal stem cells 

研究课题代号(代码):

Study subject ID:

 

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:

秦弦 

研究负责人:

袁玉峰 

Applicant:

Xian Qin 

Study leader:

Yufeng Yuan 

申请注册联系人电话:

Applicant telephone:

+86 18502747204 

研究负责人电话:

Study leader's telephone:

+86 13995564795 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

paulqqqqq@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

paulqqqqq@hotmail.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

https://znhospital.cn/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://znhospital.cn/ 

申请注册联系人通讯地址:

武汉市武昌区东湖路169号 

研究负责人通讯地址:

武汉市武昌区东湖路169号 

Applicant address:

169 Donghu Road, Wuchang District, Wuhan, Hubei 

Study leader's address:

169 Donghu Road, Wuchang District, Wuhan, Hubei 

申请注册联系人邮政编码:

Applicant postcode:

430071 

研究负责人邮政编码:

Study leader's postcode:

430071 

申请人所在单位:

武汉大学中南医院 

Applicant's institution:

Zhongnan Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

干研伦[2018]001号 

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:

武汉大学中南医院医学伦理委员会 

Name of the ethic committee:

The Medical Ethics Committee of Zhongnan Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-08-30 

伦理委员会联系人:

郑磊 

Contact Name of the ethic committee:

Lei Zheng 

伦理委员会联系地址:

武汉市武昌区东湖路169号 

Contact Address of the ethic committee:

169 Donghu Road, Wuchang District, Wuhan, Hubei 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 027-67812787 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

znyyll@126.com 

研究实施负责(组长)单位:

武汉大学中南医院 

Primary sponsor:

Zhongnan Hospital 

研究实施负责(组长)单位地址:

武汉市武昌区东湖路169号 

Primary sponsor's address:

169 Donghu Road, Wuchang District, Wuhan, Hubei 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉大学中南医院

具体地址:

武昌区东湖路169号

Institution
hospital:

Zhongnan Hospital

Address:

169 Donghu Road, Wuchang District

经费或物资来源:

北京拓华伟业生物科技有限公司 

Source(s) of funding:

Tuohua Biotechnology Co., Ltd. 

研究疾病:

乙型病毒性肝炎肝硬化 

Target disease:

Cirrhosis of Liver Due to Hepatitis B 

研究疾病代码:

 

Target disease code:

 

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:

研究目的:

(1) 初步观察人脐带间充质干细胞用于乙型病毒性肝炎肝硬化失代偿期患者的安全性和耐受性; (2) 初步观察不同剂量的人脐带间充质干细胞治疗乙型病毒性肝炎肝硬化失代偿期患者的疗效。 

Objectives of Study:

(1) To evaluate the security and tolerance of human subjects with decompensated HBV-associated liver cirrhosis treated by human UC-MSCs. (2) To evaluate the therapeutic effect of different dosage of human UC-MSCs for threating human subjects with decompensated HBV-associated liver cirrhosis. 

药物成份或治疗方案详述:

低剂量组:人脐带间充质干细胞制剂100mL,含2.5×10^7个干细胞,静脉滴注间隔7天,分别为第1天、第8天、第15天,共滴注3次; 中剂量组:人脐带间充质干细胞制剂100mL,含5.0×10^7个干细胞,静脉滴注间隔7天,分别为第1天、第8天、第15天,共滴注3次; 高剂量组:人脐带间充质干细胞制剂100mL,含1.0×10^8个干细胞,静脉滴注间隔7天,分别为第1天、第8天、第15天,共滴注3次。 

Description for medicine or protocol of treatment in detail:

1. Group low-dose:100mL with 2.5x10^7 human UC-MSCs was dripped into human subjects in day 1, day 8 and day 15. 3 times of therapy totally, interval time of 7 days. 2. Group medium-dose:100mL with 5.0x10^7 human UC-MSCs was dripped into human subjects in day 1, day 8 and day 15. 3 times of therapy totally, interval time of 7 days. 3. High low-dose:100mL with 1.0x10^8 human UC-MSCs was dripped into human subjects in day 1, day 8 and day 15. 3 times of therapy totally, interval time of 7 days. 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1. 年龄在18~65周岁(包括18和65周岁),性别不限; 2. 确诊为乙型病毒性肝炎肝硬化失代偿期; 3. 常规内科治疗效果不佳,病情反复; 4. 血浆白蛋白<35g/L,总胆红素<170μmol/L,凝血酶原活动度>30%,Child -Pugh评分≥7分;MELD评分≤15分; 5. 血红蛋白>70g/L,血小板计数>3×10^9/L; 6. 无条件接受肝移植; 7. 自愿参加本临床研究,能配合医生开展研究,并签署知情同意书。 

Inclusion criteria

1. Aged 18 to 65 years, male or female. 2. A definite diagnosis of decompensated HBV-associated liver cirrhosis. 3. Poor effect of regular therapy; or relapse frequently. 4. Albumin in plasma < 35g/L, total bilirubin<170μmol/L, PTA>30%, Child –Pugh score>=7, MELD score<=15. 5. Hemoglobin > 70g/L, platelet> 3x10^9/L. 6. Cannot receive live transplantation. 7. Patients who participate this clinical research voluntarily, and coordinate with doctors well. Also they should sign the informed consent form. 

排除标准:

1. 合并有自发性腹膜炎或其他严重感染; 2. 合并肝肾综合征者; 3. 近1月内出现严重的肝性脑病、消化道大出血或静脉曲张性出血; 4. 有门静脉血栓;合并严重的心、肺、肾、血液、内分泌系统疾病; 5. HIV阳性; 6. 自身免疫性肝病相关自身抗体阳性; 7. 存在肝脏或任何类型的恶性肿瘤; 8. 孕妇、哺乳期妇女或近期有生育计划者; 9. 有酗酒、药物滥用史,并未能有效戒除者; 10. 入组前3个月内参与过其他临床试验; 11. 曾参加过干细胞临床研究; 12. 研究者认为的患者不宜参加本研究的其他情况。 

Exclusion criteria:

1. Patients with complication of spontaneous peritonitis or other severe infection; 2. Patients with hepatorenal syndrome; 3. Suffered severe hepatic encephalopathy, massive alimentary tract bleeding or massive varicose bledding in last 1 month; 4. Patients with thrombosis in portal vein; or with complication of severe disease of heart, lung, kidney, blood system and endocrinology; 5. HIV positive; 6. Antibody of autoimmune liver diseases positive; 7. Patients who have malignant tumor in liver or other organs; 8. Female patients with pregnancy, in lactation period or who are plan to get pregnant recently; 9. Patients with insobriety, drug abused, also fail to quit it; 10. Patients who have participated in other clinical trials in last 3 months; 11. Patients who have participated in clinical trial of stem cells; 12. Patients was considered inappropriate to this trial by researchers. 

研究实施时间:

Study execute time:

From2019-09-01To 2022-08-31 

征募观察对象时间:

Recruiting time:

From2019-09-01To 2022-08-31 

干预措施:

Interventions:

组别:

低剂量组

样本量:

8

Group:

Low-dose group

Sample size:

干预措施:

人脐带间充质干细胞制剂100mL,含2.5×10^7个干细胞,静脉滴注间隔7天,分别为第1天、第8天、第15天,共滴注3次

干预措施代码:

Intervention:

100mL with 2.5×10^7 human UC-MSCs was dripped into human subjects in day 1, day 8 and day 15. 3 times of therapy totally, interval time of 7 days.

Intervention code:

组别:

中剂量组

样本量:

8

Group:

Medium-dose group

Sample size:

干预措施:

人脐带间充质干细胞制剂100mL,含5.0×10^7个干细胞,静脉滴注间隔7天,分别为第1天、第8天、第15天,共滴注3次

干预措施代码:

Intervention:

100mL with 5.0×10^7 human UC-MSCs was dripped into human subjects in day 1, day 8 and day 15. 3 times of therapy totally, interval time of 7 days.

Intervention code:

组别:

高剂量组

样本量:

8

Group:

High low-dose group

Sample size:

干预措施:

人脐带间充质干细胞制剂100mL,含1.0×10^8个干细胞,静脉滴注间隔7天,分别为第1天、第8天、第15天,共滴注3次

干预措施代码:

Intervention:

100mL with 1.0×10^8 human UC-MSCs was dripped into human subjects in day 1, day 8 and day 15. 3 times of therapy totally, interval time of 7 days.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉大学中南医院 

单位级别:

三甲 

Institution
hospital:

Zhongnan Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

生存率

指标类型:

次要指标 

Outcome:

Survival rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能指标(血清白蛋白ALB、丙氨酸氨基转移酶ALT、天冬氨酸转氨酶AST、胆碱酯酶CHE、总胆红素TBIL、直接胆红素DB、血清胆固醇CHO、凝血酶原活动度PTA、抗凝血酶AT)

指标类型:

次要指标 

Outcome:

The liver functionin (including ALB, ALT, AST, CHE, TBIL, DB, CHO, PTA, AT)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Child -Pugh评分

指标类型:

次要指标 

Outcome:

The Child-Pugh score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

受试者体重

指标类型:

次要指标 

Outcome:

The body weight of human subjects

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝腹水

指标类型:

次要指标 

Outcome:

The cirrhotic ascites

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床症状(包括下肢水肿、呕血、黄疸、乏力、纳差)

指标类型:

次要指标 

Outcome:

The clinic symptoms (Including lower limbs edema, hematemesis, jaundice, fatigue, poor appetite)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫功能指标

指标类型:

次要指标 

Outcome:

The immunologic tests

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

影像学检查

指标类型:

次要指标 

Outcome:

The imageological examination

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量评分(SF-36量表评分)

指标类型:

次要指标 

Outcome:

The quality of life (SF-36 scale)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

MELD评分

指标类型:

次要指标 

Outcome:

The MELD score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能指标(血清白蛋白ALB、丙氨酸氨基转移酶ALT、天冬氨酸转氨酶AST、胆碱酯酶CHE、总胆红素TBIL、直接胆红素DB、血清胆固醇CHO、凝血酶原活动度PTA、抗凝血酶AT)

指标类型:

主要指标 

Outcome:

The liver function (including ALB, ALT, AST, CHE, TBIL, DB, CHO, PTA, AT)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

未使用

Randomization Procedure (please state who generates the random number sequence and by what method):

Not used

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

计划于2022年以论文的方式公开数据

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