Efficacy of Infusions of Mesenchymal Stem Cells From Wharton Jelly in the Moderate to Severe SARS-Cov-2 Related Acute Respiratory Distress Syndrome (COVID-19): A Phase IIa Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- PaO2 / FiO2 ratio
研究概览
简要总结
Mesenchymal stem cells (MSCs) are of potential help in acute respiratory distress syndrome (ARDS), due to their anti-inflammatory properties.
The investigators will analyze the effect of 3 iterative infusions of ex vivo expanded Wharton's Jelly MSCs (total dose 2.10^6/kg) in patients with ARDS due to COVID19, who require mechanical ventilation.
详细描述
This study is designed to analyze the impact of Wharton's Jelly Mesenchymal Stem Cells on moderate to severe ARDS due to COVID19 in adult patients who require mechanical ventilation. It is a Phase IIa double-blind randomized controlled trial.
30 patients are planned.
Patients will be randomized and will receive, with the conventional treatment recommended to treat ARDS:
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Either Wharton's Jelly MSCs in a solution of albumin 4% (40% of final volume), NaCl 0,9% (50% of the final volume) et ACD formule A (10% of the final volume) . Treatment will be administered intravenously during 10 minutes following that scheme:
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Day 0 (or 1): 1. 10^6 MSC/kg (maximum 80.10^6 MSC)
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Day 3 (or 4): 0.5 . 10^6 MSC/kg (maximum 40. 10^6 MSC)
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Day 5 (or 6): 0.5 . 10^6 MSC/kg (maximum 40. 10^6 MSC) An interval of 2 days will be respected between 2 infusions.
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Either a placebo, which contains the same solution of albumin, NaCl 0.9% and ACD without cells. The volume will be of 75 ml, infused in 10 minutes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Man or woman 18 years of age or older
- •Patient with a biologically confirmed SARS-CoV-2 infection (by positive RT-PCR on a nasopharyngeal sample or any other sample)
- •Patient with moderate to severe ARDS according to the BERLIN definition defined by a PaO2 / FiO2 ratio <200 and with endotracheal intubation and under invasive mechanical ventilation
- •Patient hospitalized in the intensive care unit
- •Provision of a written informed consent to participate to the study or for whom the consent of a family member or support person has been obtained (if the patient is unable to give consent) or inclusion in an immediate vital emergency if applicable
- •Any woman of childbearing age with a negative Beta HCG test
- •Social Security affiliation
排除标准
- •Patient under invasive mechanical ventilation for more than 48 hours
- •Patient with a chronic respiratory disease under oxygen therapy
- •Patients with a history of Class III or IV pulmonary arterial hypertension (WHO classification)
- •Patients under ECMO
- •Immunosuppressive therapy (including corticosteroid therapy> 20 mg prednisolone)
- •Active solid tumor or in remission for less than 2 years, malignant hematological disease, asplenia
- •Patient who has received a hematopoietic stem transplantation or an organ transplant
- •Therapeutic limitations like progression to expected death within 24 hours (according to the opinion of the medical team)
- •Hypersensitivity to albumin or to any of the excipients (caprylic acid or sodium caprylate)
- •Patient included in another ongoing interventional therapeutic trial
- •Pregnant woman, parturient, nursing mother
- •Minor (not emancipated)
- •Person without liberty by judiciary or administrative decision
- •Person undergoing psychiatric care under Articles L. 3212-1 and L. 3213-1 which do not fall under the provisions of Article L. 1121-8 (hospitalization without consent).
- •Adult over 18 who are under a legal protection measure
结局指标
主要结局
PaO2 / FiO2 ratio
时间窗: day 10
The primary endpoint is the percentage of patients with a PaO2/FiO2 ratio \> 200 at D10 of treatment with MSC-GW or placebo.
次要结局
- Anti-HLA antibody rate(day 0 to day 90)
- duration of intensive care(day 0 to 90)
- respiratory function evolution(between Day 0 (or Day 1) and Day 14 of treatment)
- respiratory assistance(between day 0 (or 1) and day 28 (or last day of hospitalization if before day 28))
- organ failures 1(Day 0 to day 14)
- organ failures 2(day 0 to day 28)
- organ failures 3(day 0 to day 28)
- Cause of death(day 0 to 90)
- respiratory morbidity (TDM, functional respiratory measures)(day 90)
- immediate hypersensitivity reactions(day 0, day 3, day 5 (+/- 1day))
- viral load(day 0 to day 28 (or last day of hospitalization if before day 28))
- thromboembolic adverse events 1(day 0 to day 14)
- thromboembolic adverse events 2(day 0 to day 14)
- infectious adverse events(day 0 to day 14)
研究者
POCHON Cécile
Coordinator
Central Hospital, Nancy, France