Human Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (START)
CompletedPhase 2Results postedLast updated 10 April 2019
What this trial tests
Phase 2 trial testing Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells in Respiratory Distress Syndrome, Adult in 60 participants. Completed in 9 February 2018.
18 and older, any sex, with Respiratory Distress Syndrome, Adult. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Numbers of Patients Occurred Pre-specified Infusion Associated Events Occurring Within 6 Hours of Study InfusionPrimary· 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-relate
Group
Value
95% CI
Human Mesenchymal Stem Cells (hMSCs)
0
Plasma-Lyte A (Placebo)
0
Numbers of Patients Occurred Any Cardiac Arrest or Death Within 24 Hours of Study InfusionPrimary· 24 hours
Within 24 h of study product infusion
• Any cardiac arrest or death
Group
Value
95% CI
Human Mesenchymal Stem Cells (hMSCs)
1
Plasma-Lyte A (Placebo)
0
Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths)Primary· 12 months
Safety endpoint: Any unexpected severe adverse events in two groups
Group
Value
95% CI
Human Mesenchymal Stem Cells
20
Plasma-Lyte A
5
PaO2:FiO2 Change From Baseline to Day 3Secondary· baseline and day 3
Efficacy endpoint: PaO2:FiO2 change from baseline to day 3
Group
Value
95% CI
Human Mesenchymal Stem Cells
3.7
-1.2 – 10.8
Plasma-Lyte A
3.5
-2.7 – 8.3
Lung Injury Score From Baseline to Day 3Secondary· baseline and day 3
Murray score for acute lung injury. The range is 0 to 4. The higher score, the worst outcome.
Group
Value
95% CI
Human Mesenchymal Stem Cells
-0.50
-1.00 – -0.25
Plasma-Lyte A
-0.33
-0.67 – -0.08
Oxygenation Index Change From Baseline to Day 2Secondary· baseline and day 2
Oxygenation index with the following validated measure of respiratory function: FiO2 (%) x mean airway pressure / PaO2
Group
Value
95% CI
Human Mesenchymal Stem Cells
-30.3
-67.9 – 14.9
Plasma-Lyte A
-19.5
-47.8 – 10.9
SOFA Score Change From Baseline to Day 3Secondary· baseline and day 3
Sequential organ failure assessment score (SOFA). The SOFA score ranges from 0 to 24. The higher, the worse.
Group
Value
95% CI
Human Mesenchymal Stem Cells
-2
-4 – 0
Plasma-Lyte A
-1
-4 – 1
Number of Patients Death to Day 28Secondary· 28 days
Efficacy endpoint: all-cause mortality at day 28
Group
Value
95% CI
Human Mesenchymal Stem Cells
12
Plasma-Lyte A
3
Mortality to Day 60Secondary· 60 days
Efficacy endpoint: all-cause mortality at day 60
Group
Value
95% CI
Human Mesenchymal Stem Cells
15
Plasma-Lyte A
5
Number of Ventilator-free Days to Day 28Secondary· 28 days
Efficacy endpoint: Number of ventilator-free days to day 28.
Group
Value
95% CI
Human Mesenchymal Stem Cells
2
0 – 23
Plasma-Lyte A
17
0 – 24
Non-pulmonary Organ-failure-free Days to Day 28Secondary· 28 days
Efficacy endpoint: Non-pulmonary organ-failure-free days to day 28
Group
Value
95% CI
Human Mesenchymal Stem Cells
12
4 – 24
Plasma-Lyte A
8
4 – 15
Angiopoietin 2 Change From Baseline to 6 hSecondary· baseline and 6 hours
Biological markers of endothelial injury: angiopoietin 2
Group
Value
95% CI
Human Mesenchymal Stem Cells
-1120
-4706 – -66
Plasma-Lyte A
287
-1005 – 2374
Adverse events — posted to ClinicalTrials.gov
Time frame: 60 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Other recruiting trials for Respiratory Distress Syndrome, Adult
Currently open trials in the same condition.
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NCT04545424 — Trial of Therapeutic Hypothermia in Patients With ARDS
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NCT03368092 — Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma
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NCT03709199 — Long Term Follow up of Children Enrolled in the REDvent Study
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Michael A. Matthay
Last refreshed: 10 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02097641.