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临床试验/IRCT20200621047859N4
IRCT20200621047859N4招募中1 期

Human Placenta-Derived Mesenchymal Stem Cell Transplantation in Acute Respiratory Distress Syndrome (ARDS) Caused by COVID-19: Phase I Clinical Trial)

Modiriat Atiye Bahman Company0 个研究点目标入组 20 人开始时间: 待定最近更新:

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
20

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 no limit(—)
性别
All

入选标准

  • COVID-19 infection confirmed with positive PCR test results with clinical signs including respiratory distress, cough, fever, decreased blood oxygen saturation, and imaging results in favor of ARDS
  • Over 18 years of age
  • Bilateral opacity of lungs on CT scan
  • PaO2/FiO2 ratio < 200
  • Requires mechanical ventilation to increase oxygen saturation
  • Written informed consent (according to the patient's condition, in case of unconscious consent, the consent will be obtained from the patient's guardian).

排除标准

  • Less than 18 years of age
  • More than 96 hours passed from the diagnosis of ARDS (Based on the Berlin definition of ARDS)
  • Pregnancy or breastfeeding
  • Presence of active malignancy which has been treated in the past two years
  • Presence of severe and irreversible disease with a life expectancy of less than 6 months
  • Moderate to severe liver failure (Childs-Pugh Score> 12)
  • History of chronic lung disease with PaCO2>50 mm Hg or history of oxygen consumption at home
  • Extensive trauma in the past 5 days
  • History of lung transplantation
  • Inability to provide informed consent or meet test conditions
  • Class 3 or 4 pulmonary hypertension (WHO classification)
  • History of pulmonary embolism or deep vein thrombosis (DVT) in the past three months

研究者

发起方
Modiriat Atiye Bahman Company

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