Respiratory Distress Syndrome, AdultPhase 2STATNCT03818854
Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome
A Phase 2 study testing Human Mesenchymal Stromal Cells and Cell Reconstitution Media in people with Respiratory Distress Syndrome, Adult, run by Michael A. Matthay at 7 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- Human Mesenchymal Stromal Cells and Cell Reconstitution Media
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Nov 2019to 30 Jun 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 <250 mmHg and ≥5 cm H2O positive end-expiratory airway pressure (PEEP), as per the Berlin Criteria.
- Bilateral infiltrates consistent with pulmonary edema (defined below) on the frontal chest radiograph, or bilateral ground glass opacities on a chest CT scan.
- No clinical evidence of left atrial hypertension as a primary explanation for the bilateral pulmonary infiltrates.
- If the cause of ARDS is trauma, additional inclusion criteria will include ONE of the following relevant risk factors for developing ARDS:
Show all 12Show fewer
- Hypotension (systolic blood pressure[SBP] < 90 mmHg) in the field or in the first 24 h after injury, or
- Transfusion of 3 units of blood products in the first 24 hours following injury, or
- Meets the new Critical Administration Threshold (CAT) criteria with at least 3 units of blood in one hour, or
- Blunt or penetrating torso trauma, or
- Long bone fractures, or
- The highest level of institutional trauma activation
Who cannot join
- Age less than 18 years
- Greater than 72 hours since first meeting ARDS criteria per the Berlin definition of ARDS
- Greater than 14 days since initial ICU admission
- Inability to administer study product within 14 days of ICU admission
- PaO2/FiO2 ≥ 250 mmHg after consent obtained and before study product is administered
- Unable to obtain informed consent/no surrogate available
Show all 26Show fewer
- Pregnant or lactating
- In custody of law enforcement officials
- Burns > 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) < 9 assessed after sedation interruption, or
- Non-survivable head injury as assessed by neurosurgery
- Evidence of anoxic brain injury
- History of stroke within the last 3 years
- No intent/unwillingness to follow lung protective ventilation strategy
- Currently receiving extracorporeal life support (ECLS) or high-frequency oscillatory ventilation (HFOV)
- Anticipated extubation within 24 hours of enrollment
- Clinical evidence of left atrial hypertension as measured by a pulmonary arterial wedge pressure > 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, 77030
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Oregon Health & Science University
Portland, Oregon, 97239
University of California Davis Medical Center
Sacramento, California, 95817
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
University of California San Francisco
San Francisco, California, 94143
Harborview Medical Center
Seattle, Washington, 98112
About this study
Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) for the Treatment of Acute Respiratory Distress Syndrome
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).
Read the detailed description
This clinical study design is a randomized, double-blinded, placebo-controlled Phase 2b clinical trial using a 10 million cell/kg dose of human Mesenchymal Stromal Cells (hMSCs). Subjects will be randomized in a 1:1 randomization scheme to receive hMSCs or cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) as the placebo; the study will enroll 120 patients who achieve a stable clinical baseline and receive study product (either hMSCs or the placebo).
The Data and Safety Monitoring Board (DSMB) will review adverse outcomes and protocol compliance. A pre-specified interim review will occur after 60 subjects have been enrolled and received study product; enrollment will continue during the DSMB review. All pre-specified clinically important events and unexpected serious adverse events including death during hospitalization up to 60 days will be reported to the DSMB on an ongoing basis; the study will be stopped for a safety evaluation by the DSMB if they have any concerns or if three subjects have pre-specified clinically important events or unexpected serious adverse events except death since death will be common in this critically ill population due the nature of the underlying illness (e.g., ARDS).
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Human Mesenchymal Stromal Cells, Cell Reconstitution Media
- Keywords
- Human Mesenchymal Stromal Cells, Acute Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Mesenchymal Stromal CellsBiological
Also called hMSCs
Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.
Cell Reconstitution MediaBiological
Also called Placebo
300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
| Study group | Role | What they receive |
|---|---|---|
| Human Mesenchymal Stromal Cells | Experimental | A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Receives: Biological: Human Mesenchymal Stromal Cells |
| Cell Reconstitution Media | Experimental | A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Receives: Biological: Cell Reconstitution Media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxygenation Index (OI)
Change in OI from baseline over the 36 hours (6, 12, 18, 24, 30, 36 hours) following the initiation of the study product infusion. Lower values are considered better.
Measured: 36 hours
Secondary outcomes (26)
Acute Lung Injury Score (LIS)
Changes in the 4-point acute lung injury (LIS) score from the baseline to days 1, 2, 3 and 7, or on the last day of positive pressure ventilation prior to day 7. The LIS is a composite 4-point scoring system including the PaO2/FiO2, PEEP, lung compliance, and the extent of infiltrates on the chest X-ray. Each of the four components is categorized from 0 to 4, where a higher number is worse. The total Lung Injury Score is obtained by dividing the aggregate sum by the number of components used.
Measured: 7 days
Pulmonary Dead Space Fraction
Pulmonary Dead Space at day 1, 2, 3 and 7. The dead-space fraction is calculated as: (PaCO2 - PeCO2) ÷ PaCO2
Measured: 7 days
Change of Chest Radiograph Assessment of Pulmonary Edema (RALE Score)
Changes of RALE score at day 1, 2, 3 and 7 from baseline RALE score. To calculate RALE, each radiographic quadrant is scored for extent of consolidation (0-4) and density of opacification (1-3). The product of the consolidation and density scores for each of the four quadrants is summed. The RALE score ranges from 0 (best) to 48 (worst).
Measured: 7 days
Ventilator Free-days (VFD) Over 14 Days
Ventilator free-days over 14 days. Defined as the number of days from the time of initiating unassisted breathing to day 14 after study product administration, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 14. If a patient returns to assisted breathing and subsequently achieves unassisted breathing to day 14, VFDs will be counted from the end of the last period of assisted breathing to day 14.
Measured: 14 days
Ventilator Free-days (VFD) Over 28 Days.
Defined as the number of days from the time of initiating unassisted breathing to day 28 after study product administration, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a patient returns to assisted breathing and subsequently achieves unassisted breathing to day 28, VFDs will be counted from the end of the last period of assisted breathing to day 28.
Measured: 28 days
Duration of Assisted Ventilation Over 28 Days
Duration of assisted ventilation over 28 days in the survivors
Measured: 28 days
Percentage of Patients Achieving Pressure Support Ventilation for 2 Hours
Percentage of patients achieving pressure support ventilation equal to 5 cm H2O with positive end-expiratory pressure (PEEP) equal to 5 cm H2O for 2 hours
Measured: 28 days
Occurrence of Infection
Superficial incisional/wound infections, deep incisional wound infections, and organ/space infections, and ventilator associated pneumonia (all during the 14 days after enrollment)
Measured: 14 days
Occurrence of Thromboembolic Events
Thromboembolic events are measured by ultrasound of the deep venous system or CT-angiography of the chest ordered for clinical purposes/by treating clinicians
Measured: 60 days
Sequential Organ Failure Assessment (SOFA) Over 7 Days
SOFA score at 3 and 7 days. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems which are added up. Each score ranges from 0 to 4. SOFA score ranges from 0 (best) to 24 (worst).
Measured: 7 days
Non-pulmonary Sequential Organ Failure Assessment (SOFA) Over 7 Days
Non-pulmonary SOFA score at 3 and 7 days. The score is based on 5 different scores, one each for the cardiovascular, hepatic, coagulation, renal and neurological systems which are added up. Each score ranges from 0 to 4. SOFA score ranges from 0 (best) to 20 (worst).
Measured: 7 days
All-cause Mortality
All-cause mortality at 14, 28 and 60 days
Measured: 60 days
Glasgow Outcome Score (GCS)
Glasgow Outcome Score at hospital discharge. The GCS is a scale to evaluate level of consciousness in patients with acute brain injury. The scale assesses 3 functions: Eye Opening, Verbal Response, and Motor Response. GCS scores range from 15 (best) to 3 (worst)
Measured: 60 days
Plasma Angiopoietin-2
Change in levels of plasma angiopoietin-2 from baseline at 6, 24, 48 and 72 hours since the initiation of the study product infusion.
Measured: 72 hours
Plasma Receptor for Advanced Glycation Endproducts (RAGE)
Change in levels of plasma RAGE from baseline at 6, 24, 48 and 72 hours since the initiation of the study product infusion.
Measured: 72 hours
Plasma Interleukin-6 (IL-6)
Change in levels of plasma interleukin-6 from baseline compared to 6, 24, 48 and 72 hours
Measured: 72 hours
Plasma Interleukin-8 (IL-8)
Change in levels of plasma interleukin-8 from baseline at 6, 24, 48 and 72 hours since the initiation of study product infusion.
Measured: 72 hours
Plasma Tumor Necrosis Factor Receptor 1 (TNFR-1)
Change in levels of plasma TNFR-1 from baseline at 6, 24, 48 and 72 hours since the initiation of study product infusion.
Measured: 72 hours
Plasma Protein C
Change in levels of plasma protein C from baseline at 6, 24, 48 and 72 hours since the initiation of study product infusion.
Measured: 72 hours
Plasma Angiopoietin-1 (ANG-1)
Change in levels of plasma angiopoietin-1 from the baseline to 6, 24, 48 and 72 hours since the initiation of study product infusion.
Measured: 72 hours
Plasma Lipoxin A4
Change in levels of plasma lipoxin A4 from baseline compared to 6, 24, 48 and 72 hours
Measured: 72 hours
Plasma Resolvin D1
Change in levels of plasma Resolvin D1 from baseline compared to 6, 24, 48 and 72 hours
Measured: 72 hours
Plasma Keratinocyte Growth Factor (KGF)
Change in levels of plasma KGF from baseline at 6, 24, 48 and 72 hours since the initiation of study product infusion.
Measured: 72 hours
Urine Microalbumin
Change in levels of urine microalbumin from baseline compared to 24 and 48 hours
Measured: 48 hours
Total Protein in Min-bronchoalveolar Lavage (mBAL)
Change in total protein levels in from baseline to day 2
Measured: 2 days
Tolerability of the hMSCs - Incidence of Pre-specified Infusion-associated Events and Unexpected Severe Adverse Events
Tolerability of the hMSCs, defined as the incidence of pre-specified infusion-associated events and unexpected severe adverse events in ARDS patients treated with human MSCs
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start26 Nov 2019
- Primary completion30 Mar 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For this Phase 2b trial, after informed consent is given, an assignment will be made by computer-generated randomization to administer either hMSCs therapy or placebo with a 1:1 allocation to the hMSCs:placebo arms.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael A. Matthay
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Harborview Injury Prevention and Research Center, Oregon Health and Science University, Vanderbilt University Medical Center, The University of Texas Health Science Center, Houston, University of Minnesota
- Responsible party
- Sponsor-investigator, Michael A. Matthay, University of California, San Francisco
- Investigators
- Michael Matthay, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818854
- Sponsor's protocol ID
- UCSF-hMSC-ARDS-P1P2-12
- Acronym
- STAT
- Status last verified
- Nov 2025
- First submitted
- 24 Jan 2019
- Last updated
- 4 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have plan to share IPD data to other researchers.
Publications
Matthay MA, Zhuo H, Sarma A, Alipanah-Lechner N, Hendrickson C, Kornblith LZ, Schreiber M, Zonies D, Khan A, Robinson B, Johnson NJ, Ware LB, Guillamondegui O, Casey J, Moore L, Patel B, Kao L, Wade CE, Fox E, Cox C, Khawanja F, Aguillon Prada R, Hossri S, Callcut R, Albertson T, Delucchi KL, McMillan M, Langelier CR, Pati S, McKenna DH, Leroux C, Calfee CS, Liu KD. Treatment with Allogeneic Mesenchymal Stromal Cells for Moderate to Severe Acute Respiratory Distress Syndrome: A Double-Blind, Placebo-controlled, Multicenter Phase 2b Clinical Trial (STAT). Am J Respir Crit Care Med. 2026 Feb 1;212(3):428-439. doi: 10.1164/rccm.202411-2254OC.
PubMed 40728562
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) for the Treatment of Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT03818854
- Acronym / sponsor ID
- STAT / UCSF-hMSC-ARDS-P1P2-12
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Human Mesenchymal Stromal Cells, Acute Respiratory Distress Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Michael A. MatthayUniversity, hospital or other
- Collaborators
- United States Department of Defense, Harborview Injury Prevention and Research Center, Oregon Health and Science University, Vanderbilt University Medical Center, The University of Texas Health Science Center, Houston, University of Minnesota
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Posted 4 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This clinical study design is a randomized, double-blinded, placebo-controlled Phase 2b clinical trial using a 10 million cell/kg dose of human Mesenchymal Stromal Cells (hMSCs). Subjects will be randomized in a 1:1 randomization scheme to receive hMSCs or cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) as the placebo; the study will enroll 120 patients who achieve a stable clinical baseline and receive study product (either hMSCs or the placebo).
The Data and Safety Monitoring Board (DSMB) will review adverse outcomes and protocol compliance. A pre-specified interim review will occur after 60 subjects have been enrolled and received study product; enrollment will continue during the DSMB review. All pre-specified clinically important events and unexpected serious adverse events including death during hospitalization up to 60 days will be reported to the DSMB on an ongoing basis; the study will be stopped for a safety evaluation by the DSMB if they have any concerns or if three subjects have pre-specified clinically important events or unexpected serious adverse events except death since death will be common in this critically ill population due the nature of the underlying illness (e.g., ARDS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- For this Phase 2b trial, after informed consent is given, an assignment will be made by computer-generated randomization to administer either hMSCs therapy or placebo with a 1:1 allocation to the hMSCs:placebo arms.
| Arm | Type | Receives |
|---|---|---|
| Human Mesenchymal Stromal Cells | Experimental | Biological: Human Mesenchymal Stromal CellsA single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. |
| Cell Reconstitution Media | Experimental | Biological: Cell Reconstitution MediaA single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- A need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio <250 mmHg and ≥5 cm H2O positive end-expiratory airway pressure (PEEP), as per the Berlin Criteria.
- Bilateral infiltrates consistent with pulmonary edema (defined below) on the frontal chest radiograph, or bilateral ground glass opacities on a chest CT scan.
- No clinical evidence of left atrial hypertension as a primary explanation for the bilateral pulmonary infiltrates.
- If the cause of ARDS is trauma, additional inclusion criteria will include ONE of the following relevant risk factors for developing ARDS:
Key exclusion criteria (26 listed)
- Age less than 18 years
- Greater than 72 hours since first meeting ARDS criteria per the Berlin definition of ARDS
- Greater than 14 days since initial ICU admission
- Inability to administer study product within 14 days of ICU admission
- PaO2/FiO2 ≥ 250 mmHg after consent obtained and before study product is administered
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Mesenchymal Stromal CellsAlso: hMSCsImmediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL. | Biological | Human Mesenchymal Stromal Cells |
| Cell Reconstitution MediaAlso: Placebo300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) | Biological | Cell Reconstitution Media |
Primary outcome
Change in Oxygenation Index (OI)
Time frame: 36 hours
Change in OI from baseline over the 36 hours (6, 12, 18, 24, 30, 36 hours) following the initiation of the study product infusion. Lower values are considered better.
26 secondary outcomes
Acute Lung Injury Score (LIS)
Time frame: 7 days
Pulmonary Dead Space Fraction
Time frame: 7 days
Change of Chest Radiograph Assessment of Pulmonary Edema (RALE Score)
Time frame: 7 days
Ventilator Free-days (VFD) Over 14 Days
Time frame: 14 days
Ventilator Free-days (VFD) Over 28 Days.
Time frame: 28 days
Duration of Assisted Ventilation Over 28 Days
Time frame: 28 days
Percentage of Patients Achieving Pressure Support Ventilation for 2 Hours
Time frame: 28 days
Occurrence of Infection
Time frame: 14 days
Occurrence of Thromboembolic Events
Time frame: 60 days
Sequential Organ Failure Assessment (SOFA) Over 7 Days
Time frame: 7 days
Non-pulmonary Sequential Organ Failure Assessment (SOFA) Over 7 Days
Time frame: 7 days
All-cause Mortality
Time frame: 60 days
Glasgow Outcome Score (GCS)
Time frame: 60 days
Plasma Angiopoietin-2
Time frame: 72 hours
Plasma Receptor for Advanced Glycation Endproducts (RAGE)
Time frame: 72 hours
Plasma Interleukin-6 (IL-6)
Time frame: 72 hours
Plasma Interleukin-8 (IL-8)
Time frame: 72 hours
Plasma Tumor Necrosis Factor Receptor 1 (TNFR-1)
Time frame: 72 hours
Plasma Protein C
Time frame: 72 hours
Plasma Angiopoietin-1 (ANG-1)
Time frame: 72 hours
Plasma Lipoxin A4
Time frame: 72 hours
Plasma Resolvin D1
Time frame: 72 hours
Plasma Keratinocyte Growth Factor (KGF)
Time frame: 72 hours
Urine Microalbumin
Time frame: 48 hours
Total Protein in Min-bronchoalveolar Lavage (mBAL)
Time frame: 2 days
Tolerability of the hMSCs - Incidence of Pre-specified Infusion-associated Events and Unexpected Severe Adverse Events
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40728562Matthay MA, Zhuo H, Sarma A, Alipanah-Lechner N, Hendrickson C, Kornblith LZ, Schreiber M, Zonies D, Khan A, Robinson B, Johnson NJ, Ware LB, Guillamondegui O, Casey J, Moore L, Patel B, Kao L, Wade CE, Fox E, Cox C, Khawanja F, Aguillon Prada R, Hossri S, Callcut R, Albertson T, Delucchi KL, McMillan M, Langelier CR, Pati S, McKenna DH, Leroux C, Calfee CS, Liu KD. Treatment with Allogeneic Mesenchymal Stromal Cells for Moderate to Severe Acute Respiratory Distress Syndrome: A Double-Blind, Placebo-controlled, Multicenter Phase 2b Clinical Trial (STAT). Am J Respir Crit Care Med. 2026 Feb 1;212(3):428-439. doi: 10.1164/rccm.202411-2254OC.
- Individual participant dataSharing planned: No. We do not have plan to share IPD data to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Matthay, MD principal investigator
University of California, San Francisco
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human Mesenchymal Stromal Cells and Cell Reconstitution Media in people with Respiratory Distress Syndrome, Adult, run by Michael A. Matthay at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxygenation Index (OI) (time frame: 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03818854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.