Phase 2
N=120
Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome
Respiratory Distress Syndrome, Adult
Bottom Line
View on ClinicalTrials.gov: NCT03818854 ↗Enrolled (actual)
120
Serious AEs
4.2%
Results posted
Dec 2025
Primary outcome: Primary: Change in Oxygenation Index (OI) — -0.7; -1.5; 0.8; -1.1 cmH20/mmHg — p=0.34
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Human Mesenchymal Stromal Cells (Biological); Cell Reconstitution Media (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Michael A. Matthay
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Oxygenation Index (OI) |
-0.7; -1.5; 0.8; -1.1; 0.3; -1.0 | 0.34 |
| SECONDARY Acute Lung Injury Score (LIS) |
-0.10; -0.10; -0.07; -0.15; -0.15; -0.09 | 0.92 |
| SECONDARY Pulmonary Dead Space Fraction |
— | — |
| SECONDARY Change of Chest Radiograph Assessment of Pulmonary Edema (RALE Score) |
-0.7; 1.0; -1.1; 1.7; -0.5; 0.0 | 0.35 |
| SECONDARY Ventilator Free-days (VFD) Over 14 Days |
44; 32; 4; 7; 7; 12 | 0.01 sig |
| SECONDARY Ventilator Free-days (VFD) Over 28 Days. |
36; 27; 6; 4; 3; 1 | 0.02 sig |
| SECONDARY Duration of Assisted Ventilation Over 28 Days |
22; 10 | 0.01 sig |
| SECONDARY Percentage of Patients Achieving Pressure Support Ventilation for 2 Hours |
25; 31; 34; 30 | 0.35 |
| SECONDARY Occurrence of Infection |
3; 1; 1; 0; 20; 14 | 0.36 |
| SECONDARY Occurrence of Thromboembolic Events |
10; 8 | 0.56 |
| SECONDARY Sequential Organ Failure Assessment (SOFA) Over 7 Days |
9.2; 8.6; 8.5; 7.7 | 0.32 |
| SECONDARY Non-pulmonary Sequential Organ Failure Assessment (SOFA) Over 7 Days |
6.0; 5.5; 5.6; 4.8 | 0.39 |
| SECONDARY All-cause Mortality |
12; 8; 16; 15; 21; 18 | 0.29 |
| SECONDARY Glasgow Outcome Score (GCS) |
10.6; 11.5 | 0.41 |
| SECONDARY Plasma Angiopoietin-2 |
125; 184; 407; 288; 879; 343 | 0.56 |
| SECONDARY Plasma Receptor for Advanced Glycation Endproducts (RAGE) |
62; -137; -1249; 100; -1603; -906 | 0.60 |
| SECONDARY Plasma Interleukin-6 (IL-6) |
-10.1; -3.3; -9.1; 5.2; -10.7; 4.1 | 0.28 |
| SECONDARY Plasma Interleukin-8 (IL-8) |
-1.0; -0.4; -0.3; 0.3; -2.5; -0.7 | 0.85 |
| SECONDARY Plasma Tumor Necrosis Factor Receptor 1 (TNFR-1) |
-1; 271; 231; 1047; 721; 1596 | 0.32 |
| SECONDARY Plasma Protein C |
7.3; -2.9; 8.5; 6.8; 14.0; 12.7 | 0.16 |
| SECONDARY Plasma Angiopoietin-1 (ANG-1) |
-224; -292; 786; 582; 612; 661 | 0.85 |
| SECONDARY Plasma Lipoxin A4 |
— | — |
| SECONDARY Plasma Resolvin D1 |
— | — |
| SECONDARY Plasma Keratinocyte Growth Factor (KGF) |
— | — |
| SECONDARY Urine Microalbumin |
— | — |
| SECONDARY Total Protein in Min-bronchoalveolar Lavage (mBAL) |
— | — |
| SECONDARY Tolerability of the hMSCs - Incidence of Pre-specified Infusion-associated Events and Unexpected Severe Adverse Events |
2; 2 | >0.99 |
Summary
This is a Phase 2b, randomized, double-blind, placebo-controlled, multi-center study 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). This study is the extension of the Phase 1 pilot study (NCT01775774) and Phase 2a study (NCT02097641).
Eligibility Criteria
Inclusion Criteria
Patients will be eligible for inclusion if they meet all of the below criteria within 14 days of initial ICU admission. 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 20% of total body surface area
- WHO Class III or IV pulmonary hypertension
- History of cancer treatment in the last 2 years except for non-melanotic skin cancers
- Underlying medical condition for which 6-month mortality is estimated to be > 50%
- Moribund patient not expected to survive 24 hours
- Advanced chronic liver disease (Child-Pugh Score > 12)
- Severe chronic respiratory disease with the use of home oxygen
- Severe traumatic brain injury - defined as:
- A patient who has undergone intracranial neurosurgical intervention for monitoring or therapy (intracranial pressure monitoring, external ventricular drain, craniotomy), or
- Intracranial injury by head CT (does not include patients with minimal subarachnoid injury and/or minor skull fracture), or
- Post-resuscitation Glasgow Coma Score (GCS) 18mmHg or left ventricular failure measured by an echocardiogram with a left ventricular ejection fraction less than 40%. Clinical judgement will determine if either of these measurements needs to be carried out.
Data sourced from ClinicalTrials.gov (NCT03818854). 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.