Phase 2
N=60
Human Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (START)
Respiratory Distress Syndrome, Adult
Bottom Line
View on ClinicalTrials.gov: NCT02097641 ↗Enrolled (actual)
60
Serious AEs
46.7%
Results posted
Apr 2019
Primary outcome: Primary: Numbers of Patients Occurred Pre-specified Infusion Associated Events Occurring Within 6 Hours of Study Infusion — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells (Biological); Plasma-Lyte A (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Michael A. Matthay
- Primary completion
- Mar 2017
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 | — |
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).
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.