NCT04896853进行中（未招募）1 期
Treatment of Respiratory Complications Associated With COVID-19, Influenza A, Metapneumovirus, Respiratory Syncytial Virus Infection Using Wharton's Jelly-Umbilical Cord Mesenchymal Stromal Cells (ProTrans®): Open Phase IB Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Safety and tolerance of a single infusion of ProTrans®
研究概览
简要总结
To investigate the safety and tolerance of a single infusion of ProTrans® in subjects with "severe" respiratory complications associated with pneumonia caused by COVID-19, Influenza A, Metapneumovirus or RSV infection.
详细描述
The investigators hypothesize that the systemic delivery of WJ-MSCs exerts an anti-inflammatory action and anti-apoptotic effect in the lung of COVID-19, Influenza A, Metapneumovirus or RSV patients. The nature of these cells to immunomodulate both tissue resident and bloodborne immune cells towards a more anti-inflammatory and tolerogenic profile, results in a reduction of tissue-based inflammation within the lung and triggering of repair responses. This clinically culminates in a beneficial action on patients with "severe" respiratory complications associated with pneumonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Male or female, aged ≥18 years old
- •Has laboratory-confirmed SARS-CoV-2, Influenza A, Metapneumovirus or RSV infection as determined by reverse-transcription polymerase chain reaction (RT-PCR) in any specimen prior to inclusion.
- •Hospitalized patients.
- •Patients classified as severe pneumonia, as defined by the need for continuous supplemental oxygen 5 L/min 02 OR high flow oxygen, 35% FiO2 > 30l/min and cannot saturate > 96% NOT under "non-invasive" ventilation NOR invasive mechanical ventilation NOR ECMO.
- •Women of childbearing potential must agree to use contraception or acceptable birth control for the duration of the study. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 1:
- •intravaginal
- •transdermal, progestogen-only hormonal contraception associated with inhibition of ovulation 1:
- •injectable
- •implantable 2; intrauterine device (IUD) 2, intrauterine hormone-releasing system (IUS) 2, bilateral tubal occlusion 2, vasectomised partner 2,3, sexual abstinence 4
- •Hormonal contraception may be susceptible to interaction with the Investigational Medicinal Products (IMP), which may reduce the efficacy of the contraception method
- •Contraception methods that in the context of this guidance are considered to have low user dependency.
- •Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success. 4 In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
- •Provision of a written informed consent
排除标准
- •Inability to provide informed consent
- •Patients not expected to survive for 24 hours or mechanically ventilated at inclusion or previously during present hospitalization
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin (hCG) laboratory test
- •Patients with BMI ≥30
- •Patients with known, or previous, malignancy
- •Patients with other serious systemic diseases deemed of contra-indication by the physician
- •Patient with any of following laboratory results out of the ranges detailed below at screening: Absolute neutrophil count (ANC) ≤ 1.0 x 10e9/L, Platelets (PLT) < 50 10e9 /L, ASAT or ALAT > 5N, estimated glomerular filtration rate (eGFR) < 30 mL/min
- •Current documented bacterial infection
- •Serological evidence of infection with human immunodeficiency virus, Treponema pallidum, hepatitis B antigen (serology consistent with previous vaccination and a history of vaccination is acceptable) or hepatitis C
- •Latent or previous as well as on-going therapy against tuberculosis, or exposed to tuberculosis or have travelled in areas with high risk of tuberculosis or mycosis within the last 3 months
- •Patients with known allergies to a component of the ProTrans® product
- •Ongoing treatment with Remdesivir
- •Pre-existing chronic respiratory diseases requiring long- term oxygen therapy
- •Pre-existing cirrhosis with basal Child and Pugh of C
- •Patients with history of increased risk for thrombo- embolic and/or co-morbidity for thrombo- embolism
- •Patients with a history of myocardium infarction
- •A history of cardiac dysfunction, as assessed as:
- •Clinical sign of a congestive heart failure refractory; Left ventricular ejection fraction <35% at myocardial scintigraphy or echocardiography; Pulmonary arterial hypertension with systolic pulmonary artery pressure (PAP) at echography > 40 mmHg Chronic atrial fibrillation requiring oral anticoagulant therapy; Uncontrolled ventricular arrhythmia; Pericardial effusion with hemodynamic compromise assessed by echocardiography.
研究组 & 干预措施
Treatment
Experimental
Wharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®).Study patients 1-3 will receive a single dose of 25 million cells, patients 4-6 will receive 100 million cells and patients 7-9 will receive 200 million cells.
干预措施: ProTrans® (Biological)
结局指标
主要结局
Safety and tolerance of a single infusion of ProTrans®
时间窗: 24 months
Grade 3 or 4 adverse event but not usual in natural course of the disease.
次要结局
- Effect of ProTrans® -MSC on patient clinical status, including mortality, at day 7(7 days)
- Kinetics of COVID-19, Influenza A, Metapneumovirus, Respiratory Syncytial Virus (RSV) viral load after ProTrans® -MSC infusion(Up to 30 days)
- Evolution of biological markers of liver, myocardium and inflammation(Up to 24 months)
- Effect of ProTrans® -MSC on patient clinical status, including mortality, at day 15(15 days)
- Effect of ProTrans® -MSC on patient clinical status, including mortality, at day 30(30 days)
- Time to clinical improvement after ProTrans® - MSC infusion(30 days)
- Effect of of ProTrans® -MSC on lung damage(Up to 60 days)
- Duration of hospitalization and Intensive Care Unit (ICU) stay(Up to 60 days)
- Tolerance of allogeneic Wharton's jelly (WJ) Mesenchymal Stromal Cells (ProTrans®) for severe COVID-19, Influenza A, Metapneumovirus or RSV respiratory conditions(Up to 24 months)
研究者
研究点 (1)
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