Phase 2
Completed N=120
Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome
Respiratory Distress Syndrome, Adult
Source: ClinicalTrials.gov NCT03818854 ↗
Enrolled (actual)
120
Serious AEs
4.2%
Results posted
Dec 2025
Primary outcomePrimary: Change in Oxygenation Index (OI) — -0.7; -1.5; 0.8; -1.1 cmH20/mmHg — p=0.34
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).
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 |
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. Informational only — not medical advice.