Phase 2
Completed N=60
Human Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (START)
Respiratory Distress Syndrome, Adult
Source: ClinicalTrials.gov NCT02097641 ↗
Enrolled (actual)
60
Serious AEs
46.7%
Results posted
Apr 2019
Primary outcomePrimary: Numbers of Patients Occurred Pre-specified Infusion Associated Events Occurring Within 6 Hours of Study Infusion — 0; 0 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numbers of Patients Occurred Pre-specified Infusion Associated Events Occurring Within 6 Hours of Study Infusion |
0; 0 | — |
| PRIMARY Numbers of Patients Occurred Any Cardiac Arrest or Death Within 24 Hours of Study Infusion |
1; 0 | — |
| PRIMARY Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths) |
20; 5 | — |
| SECONDARY PaO2:FiO2 Change From Baseline to Day 3 |
3.7; 3.5 | — |
| SECONDARY Lung Injury Score From Baseline to Day 3 |
-0.50; -0.33 | — |
| SECONDARY Oxygenation Index Change From Baseline to Day 2 |
-30.3; -19.5 | — |
| SECONDARY SOFA Score Change From Baseline to Day 3 |
-2; -1 | — |
| SECONDARY Number of Patients Death to Day 28 |
12; 3 | — |
| SECONDARY Mortality to Day 60 |
15; 5 | — |
| SECONDARY Number of Ventilator-free Days to Day 28 |
2; 17 | — |
| SECONDARY Non-pulmonary Organ-failure-free Days to Day 28 |
12; 8 | — |
| SECONDARY Angiopoietin 2 Change From Baseline to 6 h |
-1120; 287 | — |
| SECONDARY Angiopoietin 2 Change From Baseline to 24 h |
-2080; -537 | — |
| SECONDARY Interleukin 6 Change From Baseline to 6 h |
-51; -20 | — |
| SECONDARY Interleukin 6 Change From Baseline to 24 h |
-34; -43 | — |
| SECONDARY Interleukin 8 Change From Baseline to 6 h |
-2; -1 | — |
| SECONDARY Interleukin 8 Change From Baseline to 24 h |
-5; -5 | — |
| SECONDARY RAGE Change From Baseline to 6 h |
-326; -322 | — |
| SECONDARY RAGE Change From Baseline to 24 h |
-393; -411 | — |
Eligibility Criteria
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:
- A need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio 12)
- Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen
- 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)
- Major trauma in the prior 5 days
- Lung transplant patient
- No consent/inability to obtain consent
- Moribund patient not expected to survive 24 hours
- World Health Organization (WHO) Class III or IV pulmonary hypertension
- Documented deep venous thrombosis or pulmonary embolism within past 3 months
- No arterial line/no intent to place an arterial line
- No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol
- Currently receiving extracorporeal life support (ECLS) or high-frequency oscillatory ventilation (HFOV)
Data sourced from ClinicalTrials.gov (NCT02097641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.