Acute Respiratory Distress Syndrome Clinical Trial
Official title:
Human Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) is a devastating inflammatory and destructive disease in critical ill patients. Preclinical studies have shown a promising perspective of mesenchymal stem cells (MSCs) therapies in ARDS. But the safety and efficacy of umbilical cord MSCs (UCMSCs) have not yet been convinced in clinical trails. This study will explore the safety and life-rescue potential of UCMSCs in refracotry ARDS.
This is a single arm study. According Berlin definition (2012), moderate or severe adult ARDS
patients who fail to improve oxygenation (PaO2/FiO2 increase over 20%) in the first 24h or 8h
after diagnosis will be enrolled. A salvage package of 10^6/kg suspended UCMSCs in 100ml
normal saline or only 100ml normal saline will be infused through central venous catheter.
Infusion associated events (IAEs) in 24 hours will be closely monitored. Compared with
propensity score matched controls, mortality in 28 days as the primary outcomes. oxygenation
index, ventilator parameters, lung injury biomarkers and clinical outcomes as secondary
outcomes will be analyzed.
This is a revised trail from its previous registered pilot RCT, approved by Ethic Committe of
Stem Cells Trails (ECSCT) of 3rd affiliated hospital of Sun Yat-Sen university
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