中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600120835
最近更新日期： Date of Last Refreshed on：	2026-03-20 10:04:03
注册时间： Date of Registration：	2026-03-20 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	干细胞疗法治疗缺血性疾病和炎症相关疾病的临床前研究
Public title：	Preclinical Research on Stem Cell Therapy for Ischemic and Inflammatory Diseases
注册题目简写：
English Acronym：
研究课题的正式科学名称：	干细胞疗法治疗缺血性疾病和炎症相关疾病的临床前研究
Scientific title：	Preclinical Research on Stem Cell Therapy for Ischemic and Inflammatory Diseases
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：	李扬	研究负责人：	吴英锋
Applicant：	Li Yang	Study leader：	Wu Yingfeng
申请注册联系人电话： Applicant telephone：	+86 10 69543901	研究负责人电话： Study leader's telephone：	+86 10 69543901
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：	ly18748176185@163.com	研究负责人电子邮件： Study leader's E-mail：	xwhvs@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)：
申请注册联系人通讯地址：	北京市通州区新华南路82号	研究负责人通讯地址：	北京市通州区新华南路82号
Applicant address：	No. 82, Xinhua South Road, Tongzhou District, Beijing	Study leader's address：	No. 82, Xinhua South Road, Tongzhou District, Beijing
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：
申请人所在单位：	首都医科大学附属北京潞河医院
Applicant's institution：	Beijing Luhe Hospital, Affiliated to Capital Medical University
研究负责人所在单位：	首都医科大学附属北京潞河医院
Affiliation of the Leader：	Beijing Luhe Hospital, Affiliated to Capital Medical University

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：	2024-LHKY-152-04	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：	首都医科大学附属北京潞河医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Beijing Luhe Hospital Affiliated to Capital Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2026-01-19 00:00:00
伦理委员会联系人：	李海燕
Contact Name of the ethic committee：	Li Haiyan
伦理委员会联系地址：	北京市通州区新华南路82号
Contact Address of the ethic committee：	No. 82, Xinhua South Road, Tongzhou District, Beijing
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 10 60569362	伦理委员会联系人邮箱： Contact email of the ethic committee：	lhyyllwyh@163.com

研究实施负责（组长）单位：

首都医科大学附属北京潞河医院

Primary sponsor：

Beijing Luhe Hospital, Affiliated to Capital Medical University

研究实施负责（组长）单位地址：

北京市通州区新华南路82号

Primary sponsor's address：

No. 82, Xinhua South Road, Tongzhou District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	北京市	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	首都医科大学附属北京潞河医院	具体地址：	北京市通州区新华南路82号
Institution hospital：	Beijing Luhe Hospital, Affiliated to Capital Medical University	Address：	No. 82, Xinhua South Road, Tongzhou District, Beijing

经费或物资来源：

北京国卫生物科技有限公司

Source(s) of funding：

Beijing GUOWEI Biotechnology Co.ltd

研究疾病：

缺血性疾病

Target disease：

Ischemic diseases

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：

其它

Study phase：

N/A

研究设计：

队列研究

Study design：

Cohort study

研究目的：

采集人源胎盘，建立人胎盘来源的干细胞制剂的工艺流程和质量标准，进行人胎盘来源的干细胞治疗缺血性疾病和炎症相关疾病的临床前研究，为缺血性疾病和炎症相关疾病的干细胞药物开发奠定基础。

Objectives of Study：

Collect human placenta samples, establish the process and quality standards for the preparation of stem cell preparations derived from human placentas, conduct preclinical research on the use of stem cells derived from human placentas for the treatment of ischemic diseases and inflammation-related diseases, and lay the foundation for the development of stem cell-based drugs for ischemic diseases and inflammation-related disorders.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Women who have reached the legal age for marriage and childbirth (over 20 years old) and whose expected age of delivery is under 38 years old (inclusive of 38 years old);
2. Normal full-term singleton pregnancies after 37 weeks and before 40+3 weeks of gestation;
3. Natural pregnancies without the use of medical assisted reproductive technologies such as artificial insemination or in vitro fertilization;
4. The mother has been in good health in the past and has no history of infectious diseases, and the infectious disease screening during pregnancy includes: Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Treponema pallidum (TP), with negative test results;
5. The vital signs, physical examination, blood routine, blood type, comprehensive biochemical tests, urine routine, and 12-lead electrocardiogram during pregnancy show normal or no clinically significant abnormalities;
6. The B-ultrasound examination during pregnancy shows that the position of the umbilical cord attachment is normal, and no abnormal shapes such as sail-shaped placenta or ball-shaped placenta are shown;
7. The donor voluntarily participates in the trial, signs a written informed consent form, and can follow the trial protocol to complete the trial, that is, agrees to collect 6 mL of venous blood for rechecking the pathogenology one day before the surgery and at 90-97 days after delivery (window period);
8. The newborn's weight should be greater than 2.5 kilograms and no more than 4.5 kilograms;
9. The newborn examination is normal, including no body deformities, normal skin color, etc.;
10. There is no severe edema or obvious deformity of the placenta and umbilical cord;
11. The diameter of the placenta is 15-25 cm, the thickness is 2-3 cm, the appearance is bright, the amniotic membrane on the fetal side is transparent, the tissue has no abnormal calcification and obvious coagulation, the umbilical cord is not twisted or knotted, and there is no coagulation in the blood vessels.

排除标准：

1.供者有子痫前期，妊娠期糖尿病，妊娠合并肝内胆汁淤积症等严重合并症及胎膜早破、绒毛膜羊膜炎等引起胎盘炎症反应的并发症；
2.供者在妊娠过程中患有无法控制的感染性疾病；
3.供者有药物滥用史（定义为使用违禁药物，如吗啡、甲基安非他明、氯胺酮、二亚甲基双氧安非他明、四氢大麻酚酸）；
4.供者近2年内有嗜酒史（嗜酒是指每周饮酒超过14单位酒精：1单位≈360 mL啤酒，或45 mL烈酒，或150 mL葡萄酒）、嗜烟史（每日吸烟数量≥10支）；
5.供者接触有毒有害物质或放射线；
6.供者夫妻双方有遗传病家族史；
7.供者在妊娠过程中参加过其他临床试验；
8.供者生产时有并发症，发生II级以上羊水污染，胎粪污染，宫内感染，体温超过38℃；
9.研究者认为存在任何可能影响供者提供知情同意或遵循试验方案的情况，或供者参加试验可能影响试验结果或供者自身安全。

Exclusion criteria：

1.Donors with severe comorbidities such as preeclampsia, gestational diabetes mellitus (GDM), intrahepatic cholestasis of pregnancy (ICP), and other complications that induce placental inflammatory responses including premature rupture of membranes (PROM) and chorioamnionitis.
2.Donors with uncontrollable infectious diseases during the course of pregnancy.
3.Donors with a history of substance abuse (defined as the use of illicit drugs, such as morphine, methamphetamine, ketamine, 3,4-methylenedioxymethamphetamine (MDMA), and tetrahydrocannabinolic acid (THCA)).
4.Donors with a history of alcohol abuse or tobacco abuse within the past 2 years (Alcohol abuse is defined as consuming more than 14 alcohol units per week: 1 unit ≈ 360 mL of beer, 45 mL of spirits, or 150 mL of wine; tobacco abuse is defined as smoking ≥10 cigarettes per day).
5.Donors with exposure to toxic and harmful substances or ionizing radiation.
6.Donors for whom both the donor and her spouse have a family history of genetic diseases.
7.Donors who have participated in other clinical trials during the course of pregnancy.
8.Donors with complications during delivery, including grade II or higher amniotic fluid contamination, meconium contamination, intrauterine infection, or a body temperature exceeding 38℃.
9.Donors in whom the investigator deems the existence of any condition that may impair the donor’s ability to provide informed consent or adhere to the trial protocol, or that the donor’s participation in the trial may compromise the trial results or the donor’s own safety.

研究实施时间：

Study execute time：

从 From 2026-02-03 00:00:00至 To 2031-01-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-03-23 00:00:00 至 To 2027-03-22 00:00:00

干预措施：

Interventions：

组别：	缺血性疾病观察组	样本量：	20
Group：	Ischemic disease observation group	Sample size：	20
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	北京市	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	首都医科大学附属北京潞河医院	单位级别：	三级
Institution hospital：	Beijing Luhe Hospital, Affiliated to Capital Medical University	Level of the institution：	Tertiary

测量指标：

Outcomes：

指标中文名：	传染病筛查	指标类型：	主要指标
Outcome：	Infectious disease screening	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：	人源胎盘	组织：
Sample Name：	Human placenta	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：	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：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	20	岁 years
最大 Max age	38	岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	无
Blinding：	None

是否共享原始数据： IPD sharing	否No
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）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	None
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：	EDC;CRF
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	EDC;CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-03-20 10:03:50