A Prospective, Double-blind, Randomized, Parallel, Placebo-controlled Pilot Clinical Trial for the Evaluation of the Efficacy and Safety of Two Doses of WJ-MSC in Patients With Acute Respiratory Distress Syndrome Secondary to Infection by COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 5
- 主要终点
- All-cause mortality at day 28
研究概览
简要总结
Randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety of 2 infusions of Wharton-Jelly mesenchymal stromal cells (day 1 and day 3, endovenously at 1E6cells/Kg per dose) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. Follow-up will be established on days 3, 5, 7, 14, 21, and 28. Long term follow-up will be performed at 3, 6 and 12 months.
详细描述
This is a prospective, double-blind, randomized, parallel, placebo-controlled pilot clinical trial to assess the efficacy and safety of two infusions of Wharton Jelly mesenchymal stromal cells (WJ-MSC) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. The study will enroll 30 patients who after signing the informed consent will be checked for inclusion and exclusion criteria. Patients will then be randomized (1:1) to one of the 2 treatment arms: Treatment A WJ-MSC/WJ-MSC; Treatment B Placebo/ Placebo. The 2 infusions will be administered endovenously on day 1 (D1) and on D3. Thereafter, patients will be followed-up on days 3, 5, 7, 14, 21, and 28 Once the study is completed, controls will be established at 3 months, 6 months and 12 months as long-term follow-up.
The study treatments (A or B) will be added on top of the Standard of Care treatment prescribed by the attending physician. Each dose of MSC-WJ will consist of the intravenous administration of 1E6cells/Kg.
Recruitment will be competitive for the centers participating in the study. A Data Safety and Monitoring Board (DSMB) will be established to review safety and efficacy along the trial.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive PCR fpr SARS-CoV-2
- •Intensive Care Unit admission for less than 3 days
- •Moderate acute respiratory distress (Berlin criteria definition with 100 mmHg < PaO2/FiO2 ≤ 200 mmHg)
- •Male or female, aged 18 to 70 years old
- •Signed informed consent by the patient or by a legal representative (in this case, can be obtained by phone, although it must be confirmed in writing later, accepted by email)
排除标准
- •Expected survival less than 3 days
- •Treatment with immunosuppressive drugs (tocilizumab, sarilumab) with corticosteroids being allowed
- •Neoplastic disease either active or without complete remission
- •Immunosuppressed patients (except treatment with corticosteroids for respiratory distress)
- •Pregnant or lactating women
- •Participation in another clinical trial with an experimental drug in the last 30 days
- •Other pathologies that, in medical judgment, contraindicate participation in the study
研究组 & 干预措施
Treatment A
Wharton-Jelly mesenchymal stromal cells on D1 and D3
干预措施: XCEL-UMC-BETA (Drug)
Treatment B
Placebo on D1 and D3
干预措施: Placebo (Other)
结局指标
主要结局
All-cause mortality at day 28
时间窗: Day 28
Number of patients who died, by treatment group
次要结局
- Safety of WJ-MSC(Day 28)
- Need for treatment with rescue medication(Day 28)
- Need and duration of mechanical ventilation(Day 28)
- Ventilator free days(Day 28)
- Evolution of PaO2 / FiO2 ratio(Day 28)
- Evolution of the SOFA index(Day 28)
- Evolution of the APACHE II score(Day 28)
- Duration of hospitalization(Day 28)
- Evolution of markers of immune response (leucocyte count, neutrophils)(Day 28)
- Feasibility of WJ-MSC administration(Day 28)
- Evolution of disease biomarker: polymerase chain reaction (RT-PCR)(Day 28)
- Evolution of disease biomarker: lactate dehydrogenase (LDH)(Day 28)
- Evolution of disease biomarker: D-dimer(Day 28)
- Evolution of disease biomarker: Ferritin(Day 28)