A Clinical Study to Explore the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles in the Treatment of Interstitial Lung Disease
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Adverse Events
研究概览
简要总结
This is an exploratory, randomized, single-blind, placebo-controlled, multiple-dose, dose-escalation clinical study. The study aims to evaluate the safety and preliminary efficacy of nebulized inhalation of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs) in patients with interstitial lung disease (ILD).
This study is designed to include three sequential dose cohorts-low, medium, and high-with dose escalation proceeding in an ascending order. Eligible subjects will be enrolled and randomized sequentially, with a planned enrollment of 8 subjects per cohort. Within each cohort, subjects will be randomly assigned in a 3:1 ratio to receive either hUCMSC-EVs or saline placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older, regardless of gender.
- •Diagnosed with interstitial lung disease (ILD).
- •High-resolution computed tomography (HRCT) findings within 3 months prior to randomization must be consistent with interstitial pulmonary imaging changes.
- •Pulmonary function test within the protocol-defined acceptable range prior to randomization.
- •Good compliance, able to understand and cooperate with the required examinations and procedures, and willing to attend follow-up visits as scheduled.
- •Voluntary participation and signing of written informed consent form.
排除标准
- •Inability to tolerate nebulized inhalation therapy.
- •Requirement for oxygen supplementation > 15 hours per day during the screening period.
- •Allergic diathesis or a history of life-threatening drug hypersensitivity.
- •History of malignancy within 5 years.
- •Active hepatitis B, hepatitis C, or HIV infection.
- •Active systemic infection requiring antibiotic therapy.
- •Clinically significant laboratory abnormalities at screening.
- •Concomitant significant or severe respiratory disease.
- •History of psychiatric illness, epilepsy, or other central nervous system disorders.
- •Concomitant severe cardiovascular, hepatic, or renal systemic disease.
- •Pregnancy, planned pregnancy in the near future, or breastfeeding.
- •Unwillingness to use effective contraception during the study period.
- •Any condition that, in the opinion of the investigator, may increase the risk to the participant or interfere with the study outcomes.
研究组 & 干预措施
Low-dose group
干预措施: Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs) (Biological)
Low-dose group
干预措施: Normal Saline Placebo (Biological)
Moderate-dose group
干预措施: Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs) (Biological)
Moderate-dose group
干预措施: Normal Saline Placebo (Biological)
High-dose group
干预措施: Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs) (Biological)
High-dose group
干预措施: Normal Saline Placebo (Biological)
结局指标
主要结局
Incidence and Severity of Adverse Events
时间窗: From first dose to Week 12
次要结局
- Change from Baseline in Forced Vital Capacity (FVC)(From first dose to Week 24)
- Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)(From first dose to Week 24)
- Change from Baseline in 6-Minute Walk Test (6MWT) Distance(From first dose to Week 24)
- Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score(From first dose to Week 24)