Respiratory Distress Syndrome, Adult
Conditions
Keywords
Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells, Acute Respiratory Distress Syndrome
Brief summary
This was a Phase 2a, randomized, double-blind, placebo-controlled, multi-center trial to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS).
Detailed description
We carried out a randomized, double-blind placebo-controlled trial of allogeneic bone marrow derived human mesenchymal stromal cells for treatment of moderate to severe ARDS in 60 patients, 40 MSC and 20 placebo, in a 2:1 randomization. This trial is the extension of the Phase 1 pilot trial (NCT01775774). Patients were followed daily for adverse events through day 28, death or hospital discharge, whichever occurs first. Vital status was collected at 6 and 12 months after study enrollment.
Interventions
BIOLOGICALAllogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells
Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells was administered intravenously over approximately 60-80 minutes.
BIOLOGICALPlasma-Lyte A
Plasma-Lyte A placebo was administered intravenously over approximately 60-80 minutes.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Massachusetts General Hospital
Stanford University
University of Pittsburgh
University of Minnesota
Ohio State University
Michael A. Matthay
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will be eligible for inclusion if they meet all of the below criteria. Criteria 1-3 must all be present within a 24-hour time period and at the time of enrollment: Acute onset (defined below) of: 1. A need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio \< 200 with at least 8 cm H2O positive end-expiratory airway pressure (PEEP) 2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph 3. No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.
Exclusion criteria
1. Age less than 18 years 2. Greater than 96 hours since first meeting ARDS criteria per the Berlin definition of ARDS 3. Pregnant or breast-feeding 4. Prisoner 5. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years 6. Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50% 7. Moderate to severe liver failure (Childs-Pugh Score \> 12) 8. Severe chronic respiratory disease with a PaCO2 \> 50 mm Hg or the use of home oxygen 9. Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest) 10. Major trauma in the prior 5 days 11. Lung transplant patient 12. No consent/inability to obtain consent 13. Moribund patient not expected to survive 24 hours 14. World Health Organization (WHO) Class III or IV pulmonary hypertension 15. Documented deep venous thrombosis or pulmonary embolism within past 3 months 16. No arterial line/no intent to place an arterial line 17. No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol 18. Currently receiving extracorporeal life support (ECLS) or high-frequency oscillatory ventilation (HFOV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of Patients Occurred Pre-specified Infusion Associated Events Occurring Within 6 Hours of Study Infusion | 6 hours | 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) |
| Numbers of Patients Occurred Any Cardiac Arrest or Death Within 24 Hours of Study Infusion | 24 hours | Within 24 h of study product infusion • Any cardiac arrest or death |
| Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths) | 12 months | Safety endpoint: Any unexpected severe adverse events in two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SOFA Score Change From Baseline to Day 3 | baseline and day 3 | Sequential organ failure assessment score (SOFA). The SOFA score ranges from 0 to 24. The higher, the worse. |
| Number of Patients Death to Day 28 | 28 days | Efficacy endpoint: all-cause mortality at day 28 |
| Mortality to Day 60 | 60 days | Efficacy endpoint: all-cause mortality at day 60 |
| Number of Ventilator-free Days to Day 28 | 28 days | Efficacy endpoint: Number of ventilator-free days to day 28. |
| Non-pulmonary Organ-failure-free Days to Day 28 | 28 days | Efficacy endpoint: Non-pulmonary organ-failure-free days to day 28 |
| Angiopoietin 2 Change From Baseline to 6 h | baseline and 6 hours | Biological markers of endothelial injury: angiopoietin 2 |
| PaO2:FiO2 Change From Baseline to Day 3 | baseline and day 3 | Efficacy endpoint: PaO2:FiO2 change from baseline to day 3 |
| Interleukin 6 Change From Baseline to 6 h | baseline and 6 hours | Biological markers of inflammation: interleukin 6 |
| Interleukin 6 Change From Baseline to 24 h | baseline and 24 hours | Biological markers of inflammation: interleukin 6 |
| Interleukin 8 Change From Baseline to 6 h | baseline and 6 hours | Biological markers of inflammation: interleukin 8 |
| Interleukin 8 Change From Baseline to 24 h | baseline and 24 hours | Biological markers of inflammation: interleukin 8 |
| RAGE Change From Baseline to 6 h | baseline and 6 hours | Biological markers of alveolar epithelial injury: receptor for advanced glycation end products (RAGE) |
| RAGE Change From Baseline to 24 h | baseline and 24 hours | Biological markers of alveolar epithelial injury: receptor for advanced glycation end products (RAGE) |
| Angiopoietin 2 Change From Baseline to 24 h | baseline and 24 hours | Biological markers of endothelial injury: angiopoietin 2 |
| Lung Injury Score From Baseline to Day 3 | baseline and day 3 | Murray score for acute lung injury. The range is 0 to 4. The higher score, the worst outcome. |
| Oxygenation Index Change From Baseline to Day 2 | baseline and day 2 | Oxygenation index with the following validated measure of respiratory function: FiO2 (%) x mean airway pressure / PaO2 |
Countries
United States
Participant flow
Recruitment details
From March 24, 2014, to Feb 9, 2017, 1038 patients were screened for eligibility, of whom 975 were excluded, and 63 were randomly assigned to a treatment group. Three patients were not eligible for treatment after randomization and, therefore, 40 patients received human mesenchymal stem cells and 20 patients received placebo.
Pre-assignment details
Three patients who were randomly assigned to receive human mesenchymal stem cells, were excluded: 2 did not meet baseline stability criteria; 1 patient's PaO2:FiO2 \> 200 mmHg.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Human Mesenchymal Stem Cells (hMSCs) | Total | Plasma-Lyte A (Placebo) |
|---|---|---|---|
| Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) III score | 104 units on a scale STANDARD_DEVIATION 31 | 99 units on a scale STANDARD_DEVIATION 32 | 89 units on a scale STANDARD_DEVIATION 33 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 18 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 42 Participants | 12 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 17 | 55 years STANDARD_DEVIATION 18 | 55 years STANDARD_DEVIATION 20 |
| Arterial pressure | 75 mm Hg STANDARD_DEVIATION 10 | 75 mm Hg STANDARD_DEVIATION 10 | 76 mm Hg STANDARD_DEVIATION 9 |
| Cause of Acute Respiratory Distress Syndrome (ARDS) Aspiration only | 4 Participants | 5 Participants | 1 Participants |
| Cause of Acute Respiratory Distress Syndrome (ARDS) Other | 1 Participants | 1 Participants | 0 Participants |
| Cause of Acute Respiratory Distress Syndrome (ARDS) Pneumonia without sepsis | 11 Participants | 16 Participants | 5 Participants |
| Cause of Acute Respiratory Distress Syndrome (ARDS) Sepsis without pneumonia | 5 Participants | 7 Participants | 2 Participants |
| Cause of Acute Respiratory Distress Syndrome (ARDS) Sepsis with pneumonia | 19 Participants | 31 Participants | 12 Participants |
| Driving pressure | 14.0 cm H2O STANDARD_DEVIATION 4.1 | 13.5 cm H2O STANDARD_DEVIATION 4.2 | 12.5 cm H2O STANDARD_DEVIATION 4.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 6 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 47 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 7 Participants | 2 Participants |
| Lung injury score (LIS) | 3.1 units on a scale STANDARD_DEVIATION 0.4 | 3.1 units on a scale STANDARD_DEVIATION 0.4 | 3.0 units on a scale STANDARD_DEVIATION 0.5 |
| Mean airway pressure | 17.8 cm H2O STANDARD_DEVIATION 4.9 | 17.4 cm H2O STANDARD_DEVIATION 4.6 | 16.4 cm H2O STANDARD_DEVIATION 3.6 |
| Minute ventilation | 11.1 L/min STANDARD_DEVIATION 3.2 | 10.6 L/min STANDARD_DEVIATION 3 | 9.6 L/min STANDARD_DEVIATION 2.4 |
| Oxygenation index | 108.1 kPa STANDARD_DEVIATION 45.9 | 103.9 kPa STANDARD_DEVIATION 44.4 | 95.7 kPa STANDARD_DEVIATION 41.2 |
| PaO2/FiO2 | 18.1 kPa STANDARD_DEVIATION 4.3 | 18.4 kPa STANDARD_DEVIATION 4.6 | 19.1 kPa STANDARD_DEVIATION 5.2 |
| Plateau airway pressure | 26.4 cm H2O STANDARD_DEVIATION 5.7 | 25.5 cm H2O STANDARD_DEVIATION 5.6 | 23.7 cm H2O STANDARD_DEVIATION 5.1 |
| Positive end-expiratory pressure (PEEP) | 12.4 cm H2O STANDARD_DEVIATION 3.7 | 11.8 cm H2O STANDARD_DEVIATION 3.4 | 10.8 cm H2O STANDARD_DEVIATION 2.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) White | 27 Participants | 40 Participants | 13 Participants |
| Region of Enrollment United States | 40 participants | 60 participants | 20 participants |
| Respiratory rate | 27.8 breaths/min STANDARD_DEVIATION 6.6 | 26.7 breaths/min STANDARD_DEVIATION 6.6 | 24.5 breaths/min STANDARD_DEVIATION 6.3 |
| Sequential Organ Failure Assessment (SOFA) | 8.1 units on a scale STANDARD_DEVIATION 3.3 | 7.7 units on a scale STANDARD_DEVIATION 3.2 | 6.9 units on a scale STANDARD_DEVIATION 2.7 |
| Sex: Female, Male Female | 23 Participants | 33 Participants | 10 Participants |
| Sex: Female, Male Male | 17 Participants | 27 Participants | 10 Participants |
| Taking vasopressors at the time of infusion | 24 Participants | 33 Participants | 9 Participants |
| Tidal volume | 6.3 mL/kg predicted body weight STANDARD_DEVIATION 0.9 | 6.2 mL/kg predicted body weight STANDARD_DEVIATION 0.9 | 6.1 mL/kg predicted body weight STANDARD_DEVIATION 0.7 |
| Ventilation mode Other | 2 Participants | 3 Participants | 1 Participants |
| Ventilation mode Pressure-regulated volume control | 1 Participants | 3 Participants | 2 Participants |
| Ventilation mode Volume control | 37 Participants | 54 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 15 / 40 | 5 / 20 |
| other Total, other adverse events | 2 / 40 | 2 / 20 |
| serious Total, serious adverse events | 17 / 40 | 11 / 20 |
Outcome results
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
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | Numbers of Patients Occurred Any Cardiac Arrest or Death Within 24 Hours of Study Infusion | 1 Participants |
| Plasma-Lyte A (Placebo) | Numbers of Patients Occurred Any Cardiac Arrest or Death Within 24 Hours of Study Infusion | 0 Participants |
Primary
Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths)
Safety endpoint: Any unexpected severe adverse events in two groups
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths) | 20 Participants |
| Plasma-Lyte A (Placebo) | Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths) | 5 Participants |
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)
Time frame: 6 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | Numbers of Patients Occurred Pre-specified Infusion Associated Events Occurring Within 6 Hours of Study Infusion | 0 Participants |
| Plasma-Lyte A (Placebo) | Numbers of Patients Occurred Pre-specified Infusion Associated Events Occurring Within 6 Hours of Study Infusion | 0 Participants |
Secondary
Angiopoietin 2 Change From Baseline to 24 h
Biological markers of endothelial injury: angiopoietin 2
Time frame: baseline and 24 hours
Population: The values were not available in two patients treated with hMSC and two patients treated with placebo.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | Angiopoietin 2 Change From Baseline to 24 h | -2080 pg/mL |
| Plasma-Lyte A (Placebo) | Angiopoietin 2 Change From Baseline to 24 h | -537 pg/mL |
Secondary
Angiopoietin 2 Change From Baseline to 6 h
Biological markers of endothelial injury: angiopoietin 2
Time frame: baseline and 6 hours
Population: The biomarker values were missing in one patient treated with hMSC and one patient treated with placebo.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | Angiopoietin 2 Change From Baseline to 6 h | -1120 pg/mL |
| Plasma-Lyte A (Placebo) | Angiopoietin 2 Change From Baseline to 6 h | 287 pg/mL |
Secondary
Interleukin 6 Change From Baseline to 24 h
Biological markers of inflammation: interleukin 6
Time frame: baseline and 24 hours
Population: The values were not available in two patients treated with hMSC and two patients treated with placebo.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | Interleukin 6 Change From Baseline to 24 h | -34 pg/mL |
| Plasma-Lyte A (Placebo) | Interleukin 6 Change From Baseline to 24 h | -43 pg/mL |
Secondary
Interleukin 6 Change From Baseline to 6 h
Biological markers of inflammation: interleukin 6
Time frame: baseline and 6 hours
Population: The values were not available in one patient treated with hMSC and one patient treated with placebo.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | Interleukin 6 Change From Baseline to 6 h | -51 pg/mL |
| Plasma-Lyte A (Placebo) | Interleukin 6 Change From Baseline to 6 h | -20 pg/mL |
Secondary
Interleukin 8 Change From Baseline to 24 h
Biological markers of inflammation: interleukin 8
Time frame: baseline and 24 hours
Population: The values were not available in two patients treated with hMSC and two patients treated with placebo.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | Interleukin 8 Change From Baseline to 24 h | -5 pg/mL |
| Plasma-Lyte A (Placebo) | Interleukin 8 Change From Baseline to 24 h | -5 pg/mL |
Secondary
Interleukin 8 Change From Baseline to 6 h
Biological markers of inflammation: interleukin 8
Time frame: baseline and 6 hours
Population: The values were not available in one patient treated with hMSC and one patient treated with placebo.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | Interleukin 8 Change From Baseline to 6 h | -2 pg/mL |
| Plasma-Lyte A (Placebo) | Interleukin 8 Change From Baseline to 6 h | -1 pg/mL |
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.
Time frame: baseline and day 3
Population: The values were missing in 9 hMSC patients and 2 placebo patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | Lung Injury Score From Baseline to Day 3 | -0.50 units on a scale |
| Plasma-Lyte A (Placebo) | Lung Injury Score From Baseline to Day 3 | -0.33 units on a scale |
Secondary
Mortality to Day 60
Efficacy endpoint: all-cause mortality at day 60
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | Mortality to Day 60 | 15 Participants |
| Plasma-Lyte A (Placebo) | Mortality to Day 60 | 5 Participants |
Secondary
Non-pulmonary Organ-failure-free Days to Day 28
Efficacy endpoint: Non-pulmonary organ-failure-free days to day 28
Time frame: 28 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | Non-pulmonary Organ-failure-free Days to Day 28 | 12 days |
| Plasma-Lyte A (Placebo) | Non-pulmonary Organ-failure-free Days to Day 28 | 8 days |
Secondary
Number of Patients Death to Day 28
Efficacy endpoint: all-cause mortality at day 28
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | Number of Patients Death to Day 28 | 12 Participants |
| Plasma-Lyte A (Placebo) | Number of Patients Death to Day 28 | 3 Participants |
Secondary
Number of Ventilator-free Days to Day 28
Efficacy endpoint: Number of ventilator-free days to day 28.
Time frame: 28 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | Number of Ventilator-free Days to Day 28 | 2 days |
| Plasma-Lyte A (Placebo) | Number of Ventilator-free Days to Day 28 | 17 days |
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
Time frame: baseline and day 2
Population: The values were missing in 16 patients treated by MSC and 6 patients treated by placebo
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | Oxygenation Index Change From Baseline to Day 2 | -30.3 kPa |
| Plasma-Lyte A (Placebo) | Oxygenation Index Change From Baseline to Day 2 | -19.5 kPa |
Secondary
PaO2:FiO2 Change From Baseline to Day 3
Efficacy endpoint: PaO2:FiO2 change from baseline to day 3
Time frame: baseline and day 3
Population: The values of PaO2:FiO2 were not available in 10 patients treated with hMSCs and in 2 patients treated with placebo.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | PaO2:FiO2 Change From Baseline to Day 3 | 3.7 kPa |
| Plasma-Lyte A (Placebo) | PaO2:FiO2 Change From Baseline to Day 3 | 3.5 kPa |
Secondary
RAGE Change From Baseline to 24 h
Biological markers of alveolar epithelial injury: receptor for advanced glycation end products (RAGE)
Time frame: baseline and 24 hours
Population: The values were not available in two patients treated with hMSC and two patients treated with placebo.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | RAGE Change From Baseline to 24 h | -393 pg/mL |
| Plasma-Lyte A (Placebo) | RAGE Change From Baseline to 24 h | -411 pg/mL |
Secondary
RAGE Change From Baseline to 6 h
Biological markers of alveolar epithelial injury: receptor for advanced glycation end products (RAGE)
Time frame: baseline and 6 hours
Population: The values were not available in one patient treated with hMSC and one patient treated with placebo.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | RAGE Change From Baseline to 6 h | -326 pg/mL |
| Plasma-Lyte A (Placebo) | RAGE Change From Baseline to 6 h | -322 pg/mL |
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.
Time frame: baseline and day 3
Population: The values were missing in 3 MSC patients and 1 placebo patient.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Human Mesenchymal Stem Cells (hMSCs) | SOFA Score Change From Baseline to Day 3 | -2 units on a scale |
| Plasma-Lyte A (Placebo) | SOFA Score Change From Baseline to Day 3 | -1 units on a scale |