IRCT20200217046526N2招募中2 期
Mesenchymal Stem Cell Therapy for Acute Respiratory Distress Syndrome in Coronavirus Infection: A Phase 2-3 Clinical Trial
Iranian academic center for education culture and research0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65 years（—）
- 性别
- All
入选标准
- •Confirmation of 2019-nCoV infection by RT-PCR
- •Diagnosis of ARDS according to the Berlin definition of ARDS
- •Requiring supplemental oxygen, OR Pneumonia that is judged by chest radiograph or CT
- •PaO2/oxygen absorption concentration (FiO2) = 300MMHG
- •Pulmonary imaging shows that the focused progress > 50% in 24-48 hours
- •Mild to Moderate 2019-nCoV pneumonia/ stay in the ICU <48 hours
- •SOFA score between 2-3 point
排除标准
- •Severe allergies or allergies after 1st injection to stem cell preparations and their components
- •Patients with a malignant tumor, other serious systemic diseases, and psychosis
- •Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus
- •Patients with previous history of pulmonary embolism
- •Be thought by researchers to be inappropriate to participate in this clinical study (Expected deaths within 48 hours, uncontrolled infections)
- •Liver or kidney SOFA score of more than 3 points; combined with other organ failure (need organ support), Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30)
- •Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia
- •Continuous use of immunosuppressive agents or organ transplants in the past 6 months
- •In vitro life support (ECMO, ECCO2R, RRT)
- •Pregnant or lactating women
- •Uncontrolled underling disease
研究者
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