Safety and Preliminary Efficacy of hUCMSC-EVs in Interstitial Lung Disease

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs)
  hUCMSC-EVs , nebulized BID × 7d/cycle, 3 cycles
• Биопрепарат Normal Saline Placebo
  Nebulized inhalation BID × 7d per cycle, 3 cycles

Первичные конечные точки

• Incidence and Severity of Adverse Events [Срок оценки: From first dose to Week 12]

Вторичные конечные точки (4)

• Change from Baseline in Forced Vital Capacity (FVC) [Срок оценки: From first dose to Week 24]
• Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) [Срок оценки: From first dose to Week 24]
• Change from Baseline in 6-Minute Walk Test (6MWT) Distance [Срок оценки: From first dose to Week 24]
• Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score [Срок оценки: From first dose to Week 24]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongshan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT07570836 · ACE001-RI001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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