Human Cord derived MSC(Tianjin Amcellgene Engineering)

Main purpose To evaluate the tolerability and safety of mesenchymal stem cells (umbilical cord) for injection in the treatment of patients with traumatic spinal cord injury and determine the scope of clinical use. Secondary purpose To preliminarily explore the effectiveness of mesenchymal stem cells (umbilical cord) for injection in the treatment of patients with traumatic spinal cord injury and provide a basis for the selection of experimental drug doses in subsequent confirmation phase clinical trials. Exploration purpose To further explore the pharmacokinetic characteristics, immunogenicity, possible molecular mechanisms and changes in fMRI and neuroelectrophysiological tests of mesenchymal stem cells (umbilical cord) for injection in the treatment of patients with traumatic spinal cord injury.

Primary objectives (1) To evaluate the safety and tolerability of mesenchymal stem cells (umbilical cord) for injection in the treatment of patients with acute respiratory distress syndrome (ARDS), and to preliminarily explore its clinical efficacy and possible mechanisms. (2) The number and severity of DLTs Secondary objectives (1) To preliminarily observe whether mesenchymal stem cells (umbilical cord) for injection in the treatment of acute respiratory distress syndrome (ARDS) can reduce the risk of death in patients within 28 days. (2) To evaluate the total time without mechanical ventilation in patients with invasive mechanical ventilation within 28 days after MSCs infusion. (3) Changes in oxygenation index (OI) (time range: from day 0 to day 7 or leaving the ICU, whichever occurs first, measured once a day). (4) Lung injury score (LIS) (time range: determined by the actual measurement time of lung injury score-related items, chest CT or chest X-ray, PEEP, oxygenation index and static lung compliance (if measurable))