| Primary | Numbers of Patients Occurred Pre-specified Infusion Associated Events Occurring Within 6 Hours of Study Infusion | Within 6 h of study product infusion:
- Increase in vasopressor dose to the following values or higher:
- Norepinephrine 10 μg/min
- Phenylephrine 100 μg/min
- Dopamine 10 μg/kg per min
- Epinephrine 0.1 μg/kg per min or addition of a third vasopressor
- New ventricular tachycardia, ventricular fibrillation or asystole
- New cardiac arrhythmia requiring cardioversion
- Hypoxaemia requiring an increase in FiO2 of 0·2 or more and an increase in PEEP of 5·0 or more to maintain SpO2 in the target range of 88-95%
- Clinical scenario consistent with transfusion incompatibility or transfusion-related infection (eg, urticaria, new bronchospasm)
| | Posted | | Count of Participants | | Participants | | 6 hours | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells (hMSCs) | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A (Placebo) | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Primary | Numbers of Patients Occurred Any Cardiac Arrest or Death Within 24 Hours of Study Infusion | Within 24 h of study product infusion • Any cardiac arrest or death | | Posted | | Count of Participants | | Participants | | 24 hours | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells (hMSCs) | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A (Placebo) | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Primary | Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths) | Safety endpoint: Any unexpected severe adverse events in two groups | | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | PaO2:FiO2 Change From Baseline to Day 3 | Efficacy endpoint: PaO2:FiO2 change from baseline to day 3 | The values of PaO2:FiO2 were not available in 10 patients treated with hMSCs and in 2 patients treated with placebo. | Posted | | Median | Inter-Quartile Range | kPa | | baseline and day 3 | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | Lung Injury Score From Baseline to Day 3 | Murray score for acute lung injury. The range is 0 to 4. The higher score, the worst outcome. | The values were missing in 9 hMSC patients and 2 placebo patients. | Posted | | Median | Inter-Quartile Range | units on a scale | | baseline and day 3 | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | Oxygenation Index Change From Baseline to Day 2 | Oxygenation index with the following validated measure of respiratory function: FiO2 (%) x mean airway pressure / PaO2 | The values were missing in 16 patients treated by MSC and 6 patients treated by placebo | Posted | | Median | Inter-Quartile Range | kPa | | baseline and day 2 | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | SOFA Score Change From Baseline to Day 3 | Sequential organ failure assessment score (SOFA). The SOFA score ranges from 0 to 24. The higher, the worse. | The values were missing in 3 MSC patients and 1 placebo patient. | Posted | | Median | Inter-Quartile Range | units on a scale | | baseline and day 3 | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | Number of Patients Death to Day 28 | Efficacy endpoint: all-cause mortality at day 28 | | Posted | | Count of Participants | | Participants | | 28 days | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | Mortality to Day 60 | Efficacy endpoint: all-cause mortality at day 60 | | Posted | | Count of Participants | | Participants | | 60 days | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | Number of Ventilator-free Days to Day 28 | Efficacy endpoint: Number of ventilator-free days to day 28. | | Posted | | Median | Inter-Quartile Range | days | | 28 days | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | Non-pulmonary Organ-failure-free Days to Day 28 | Efficacy endpoint: Non-pulmonary organ-failure-free days to day 28 | | Posted | | Median | Inter-Quartile Range | days | | 28 days | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | Angiopoietin 2 Change From Baseline to 6 h | Biological markers of endothelial injury: angiopoietin 2 | The biomarker values were missing in one patient treated with hMSC and one patient treated with placebo. | Posted | | Median | Inter-Quartile Range | pg/mL | | baseline and 6 hours | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | Angiopoietin 2 Change From Baseline to 24 h | Biological markers of endothelial injury: angiopoietin 2 | The values were not available in two patients treated with hMSC and two patients treated with placebo. | Posted | | Median | Inter-Quartile Range | pg/mL | | baseline and 24 hours | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | Interleukin 6 Change From Baseline to 6 h | Biological markers of inflammation: interleukin 6 | The values were not available in one patient treated with hMSC and one patient treated with placebo. | Posted | | Median | Inter-Quartile Range | pg/mL | | baseline and 6 hours | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | Interleukin 6 Change From Baseline to 24 h | Biological markers of inflammation: interleukin 6 | The values were not available in two patients treated with hMSC and two patients treated with placebo. | Posted | | Median | Inter-Quartile Range | pg/mL | | baseline and 24 hours | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | Interleukin 8 Change From Baseline to 6 h | Biological markers of inflammation: interleukin 8 | The values were not available in one patient treated with hMSC and one patient treated with placebo. | Posted | | Median | Inter-Quartile Range | pg/mL | | baseline and 6 hours | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | Interleukin 8 Change From Baseline to 24 h | Biological markers of inflammation: interleukin 8 | The values were not available in two patients treated with hMSC and two patients treated with placebo. | Posted | | Median | Inter-Quartile Range | pg/mL | | baseline and 24 hours | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | RAGE Change From Baseline to 6 h | Biological markers of alveolar epithelial injury: receptor for advanced glycation end products (RAGE) | The values were not available in one patient treated with hMSC and one patient treated with placebo. | Posted | | Median | Inter-Quartile Range | pg/mL | | baseline and 6 hours | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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| Secondary | RAGE Change From Baseline to 24 h | Biological markers of alveolar epithelial injury: receptor for advanced glycation end products (RAGE) | The values were not available in two patients treated with hMSC and two patients treated with placebo. | Posted | | Median | Inter-Quartile Range | pg/mL | | baseline and 24 hours | | | | ID | Title | Description |
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| OG000 | Human Mesenchymal Stem Cells | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes. Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes. | | OG001 | Plasma-Lyte A | A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes. Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes. |
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