NCT04537351已完成1 期
A Pilot, Open-label, Randomised Controlled Clinical Trial to Investigate Early Efficacy of CYP-001 in Adults Admitted to Intensive Care With Respiratory Failure
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 10
- 主要终点
- Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between groups
研究概览
简要总结
This is a pilot, multi-centre, open-label randomised controlled study to assess the early efficacy of intravenous (IV) administration of CYP-001 in adults admitted to an intensive care unit (ICU) with respiratory failure
详细描述
After enrolment upon meeting eligibility criteria (D0), participants baseline data will be collected and participants will be randomised to receive either standard of care treatment only, or standard of care plus CYP-001. On D1 and D3, each participant randomised to receive CYP-001 will receive an IV infusion of 2 million Cymerus mesenchymal stem cells (MSCs)/kg of body weight (up to a maximum of 200 million cells). Participants will have further data collection throughout their ICU and hospital stay and follow up to 28 days.
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
- None
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
- •Male or female, 18 years of age or older
- •Respiratory failure with the following signs and symptoms:
- •P/F ratio <300 mmHg
- •Onset within one week of a known insult or new or worsening respiratory symptoms.
- •Chest imaging shows bilateral opacities, which are not fully explained by effusions, lobar/lung collapse, or nodules.
- •Respiratory failure which is not fully explained by cardiac failure or fluid overload.
- •Onset of respiratory failure within the past 48 hours (as defined in inclusion criterion 2
排除标准
- •<18 years of age
- •Patient is known to be pregnant
- •Known active malignancy that required treatment in the last year
- •WHO Class III or IV pulmonary hypertension
- •Venous thromboembolism currently receiving anti-coagulation or within the past 3 months
- •Currently receiving extracorporeal life support
- •Severe chronic liver disease (Child-Pugh score >12)
- •"Do Not Attempt Resuscitation" order in place
- •Treatment withdrawal imminent within 24 hours
- •BMI > 45 kg/m
- •Received any investigational research agent within 60 days or within five half-lives of the last treatment (if the half-life of the investigational agent is known to be longer than 12 days) prior to the planned administration of study treatment.
- •Known positive test for human immunodeficiency virus 1 (HIV 1), HIV 2, hepatitis B virus, Hepatitis C virus or any other infection which the opinion of the Investigator is likely to impact on the ability of the patient to participate in the study.
- •Known sensitivity to dimethylsulfoxide (DMSO) or any other component of the study treatment.
结局指标
主要结局
Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between groups
时间窗: 7 days
Assessment of respiratory dysfunction
次要结局
- Changes in oxygenation index(28 days)
- Incidence and severity of treatment-emergent adverse events(28 days)
- Proportional differences between groups on the Clinical Improvement Scale(28 days)
- Changes in respiratory rate(28 days)
- Changes in respiratory compliance (the change in lung volume per unit change in transmural pressure gradient)(28 days)
- Changes in positive end-expiratory pressure(28 days)
- Changes in P/F ratio(28 days)
- Change in C-reactive protein (CRP) levels(7 days)
- Proportional differences between groups on the SF-36(28 days)
- Proportional differences between groups on the mini mental state examination(28 days)
- Ventilator-free days(28 days)
研究者
研究点 (10)
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