NCT07041801招募中1 期
Phase I/II Clinical Study on the Safety, Efficacy, Pharmacodynamics and Immunogenicity of Human Umbilical Cord Mesenchymal Stem Cell Injection (hUCMSCs) in the Treatment of Patients With Moderate to Severe Systemic Lupus Erythematosus
Shenzhen Beike Bio-Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年6月28日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This study will investigate the safety and efficacy of allogeneic umbilical cord-derived stem cell therapy in treating patients with moderate to severe systemic lupus erythematosus.
详细描述
Inclusion criteria:
- Fully understand the purpose, nature, methods of the trial, as well as possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form.
- Age 18-65 years old (inclusive of the boundaries, based on the date of signing the informed consent form), regardless of gender;
- The subjects (both male and female) must agree not to have a reproductive plan during the trial period and after the injection administration for at least 12 months, and voluntarily take effective contraceptive measures with their partners (see Appendix 1), and have no plans for sperm donation or egg donation;
- According to the diagnostic classification criteria of the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR) in 2019, diagnosed with systemic lupus erythematosus (SLE);
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand the purpose, nature, methods of the trial and possible adverse reactions, voluntarily become a subject, and sign the informed consent form.
- •Age 18-65 years old (inclusive of the boundary values, based on the time of signing the informed consent form), no gender restrictions;
- •The subjects (male and female) must agree not to have a reproductive plan during the trial period and after the injection administration for at least 12 months, and voluntarily take effective contraceptive measures with their partners (see Appendix 1), and have no plans for sperm donation or egg donation;
- •According to the diagnostic classification criteria of the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) in 2019, diagnosed with systemic lupus erythematosus (SLE);
- •Meet one of the following conditions: the antinuclear antibody (ANA) is positive at 1:80 during screening or the anti-dsDNA antibody is positive during screening or the anti-Sm antibody is positive during screening;
排除标准
- •Those who are judged by the researchers to be likely to be allergic to the investigational drug or any component thereof;
- •Those who have had central nervous system diseases within 8 weeks before administration (including but not limited to epilepsy, mental illness, interstitial encephalopathy syndrome, stroke, encephalitis, central nervous system vasculitis, etc.);
- •Those who have undergone major organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplantation;
- •Those who have any major diseases/diseases or unstable clinical conditions (such as liver, kidney, hematological, endocrine, pulmonary, immune, mental, etc.) or active infections/infectious diseases with evidence, and according to the researchers' clinical judgment, if the subjects participate in the study, it will significantly increase the risks for the subjects;
- •Those who currently have known or suspected malignant tumors;
- •Those who have severe pulmonary arterial hypertension (>70 mmHg, 1 mmHg = 0.133 kPa), or mild to moderate pulmonary arterial hypertension patients with severe cardiopulmonary insufficiency;
- •Those who have antiphospholipid syndrome (APS), or have a history of catastrophic antiphospholipid syndrome (CAPS), or although not diagnosed as APS, but are evaluated by the researchers as having an increased risk of thrombosis;
- •Those who have herpes zoster infection within 90 days before administration, or any infection that requires hospitalization treatment or intravenous or intramuscular injection of antibiotics within 60 days before administration;
- •Those who have undergone major surgical operations within 28 days before administration, or those who are expected to undergo major surgical operations during the trial;
- •Subjects who have positive serological tests for viral hepatitis during the screening period, positive human immunodeficiency virus antibody (HIV-Ab), positive hepatitis B surface antigen (HBsAg), positive hepatitis C antibody (HCV-Ab), or positive Treponema pallidum antibody (TP-Ab);
- •Other situations that the researchers consider may affect the subjects' willingness to provide informed consent or follow the trial protocol, or situations where the subjects' participation in the trial may affect the trial results or their own safety.
研究组 & 干预措施
hUC-MSCs treatment (low dose)
Experimental
Conventional plus hUC-MSCs treatment (low dose)
干预措施: hUC-MSCs treatment (low dose) (Drug)
hUC-MSCs treatment （medium dose）
Experimental
conventional therapy plus hUC-MSCs treatment （medium dose）
干预措施: hUC-MSCs treatment (medium dose) (Biological)
hUC-MSCs treatment （high dose）
Experimental
conventional therapy plus hUC-MSCs treatment （high dose）
干预措施: hUC-MSCs treatment (high dose) (Biological)
hUC-MSCs treatment （Double dose）
Experimental
conventional therapy plus hUC-MSCs treatment（Double dose）
干预措施: hUC-MSCs treatment （Double dose） (Biological)
Placebo
Placebo Comparator
conventional therapy plus Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: day 1 to day 28
Analysis for the primary endpoint will be descriptive in nature. safety and tolerability will be measured by the number of AEs and SAEs observed. Adverse event incidents will be summarized descriptively. The severity grade of each recorded AE, and their relationship to study treatment will be analyzed. The action taken and outcome will also be analyzed accordingly.
次要结局
- Efficacy Endpoint(The 24th week after administration of the test drug.)
研究者
研究点 (1)
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