临床试验/NCT05354141

NCT05354141招募中3 期

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles for Hospitalized Patients With Moderate-to-Severe ARDS: A Phase III Clinical Trial

Direct Biologics, LLC32 个研究点分布在 1 个国家目标入组 970 人开始时间: 2022年7月1日最近更新: 2026年2月23日

适应症

干预措施

试验速览

阶段: 3 期
状态: 招募中
发起方: Direct Biologics, LLC
入组人数: 970
试验地点: 32
主要终点: Evaluation of 60-day All-cause Mortality

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EVs), ExoFlo, versus placebo for the treatment of hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).

详细描述

This is a Phase III, multicenter, randomized, double-blinded, placebo-controlled trial for the treatment of moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).

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: Triple (Participant, Care Provider, Investigator)

盲法说明

Double-Blinded

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Men and women aged 18-75 years of age
•Presence of the following criteria for moderate to severe ARDS as defined by the Berlin Criteria within 24 hours of the first infustion:
•Onset within 7 days of known clinical insult or requiring increasing respiratory rate, increasing oxygen flows, or increased work of breathing, and
•Bilateral lung opacities not fully explained by pleural effusions, atelectasis, or nodules, and
•PaO2/FiO2 (P/F ratio) ≤ 200 mm Hg, and
•Invasive or noninvasive ventilation with a minimum PEEP 5 cm H2O or minimum of continuous positive airway pressure (CPAP) 5 cm H2O, or High Flow Nasal Oxygen at ≥ 30 L/min, and
•Respiratory failure not fully explained by cardiac failure or fluid overload.

排除标准

•Lack of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy).
•Stated unwillingness to comply with all study procedures and availability for the duration of the study
•Vulnerable populations such as pregnant patients, children, individuals with severe physical or mental disabilities who cannot provide meaningful consent.
•Active malignancy requiring treatment within the last two years, with the exception of non-melanoma skin cancers.
•Major physical trauma in the last 2 days, including motor vehicle accidents, assaults, mechanical falls with sequelae of significant bleeding or craniofacial bruising, and surgeries, such that not one or more injury may be undiagnosed at time of screening.
•Duration of mechanical ventilation exceeds 3 days or 72 hours from diagnosis of ARDS.
•ALT or AST > 8 x Upper Limit of Normal (ULN).
•Documented history of cirrhosis.
•DNR order, as in electing not to receive chest compressions, cardiac defibrillation, cardiac drugs, or intubation.
•Moribund-expected survival < 24 hours.
•Severe metabolic disturbances at randomization (e.g., ketoacidosis, pH < 7.2)
•Patient currently connected to Extracorporeal Membrane Oxygenation at initiation of screening.
•If the candidate, either a male or female of reproductive potential, is unwilling to two methods of highly effective birth control contraception such as condoms with oral contraceptive pill or choose to remain abstinent if already practicing abstinence during the screening period. The required duration of usage of double method OR maintenance of abstinence must include the time from the beginning of the screening period until Day 61, day of withdrawal or early termination
•Use of investigational COVID-19 agents or any other investigational agents within 30 days prior to the first dose.

研究组 & 干预措施

Placebo

Placebo Comparator

Normal saline 100 mL

干预措施: Intravenous normal saline (Other)

Experimental Dose

Experimental

Normal saline 85 mL and ExoFlo 15 mL

干预措施: ExoFlo (Biological)

结局指标

主要结局

Evaluation of 60-day All-cause Mortality

时间窗: 60 days

To evaluate the 60-day mortality rate for IMP 15mL as a treatment for moderate-to-severe ARDS compared to placebo. Reducing the mortality rate for hospitalized patients with moderate-to-severe ARDS is a measure of the treatment effect.

次要结局

Time to death(60 days)
Ventilator-free days (VFDs)(Day 29)
Oxygen free days(Day 29)
ICU free days(Day 29)
Incidence of Treatment Emergent Serious Adverse Events (TESAEs)(61 days)

研究者

发起方

Direct Biologics, LLC

申办方类型

Industry

责任方

Sponsor

研究点 (32)

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