Mesenchymal Stromal CellsPhase 3NCT04371393
MSCs in COVID-19 ARDS
A Phase 3 study testing Remestemcel-L in people with Mesenchymal Stromal Cells and Remestemcel-L, run by Icahn School of Medicine at Mount Sinai at 21 sites in United States.
Trial summary
The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesenchymal Stromal Cells, Remestemcel-L, Acute Respiratory Distress Syndrome
- What is being tested?
- Remestemcel-L
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 21 sitesUnited States
- Study dates
- 30 Apr 2020to 2 Jan 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 18 years or older
- Patient has SARS-CoV-2 (COVID-19) confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) assay or other diagnostic test
- Patient requiring mechanical ventilatory support with moderate to severe ARDS as determined by the following criteria (adapted from the Berlin criteria)
- Bilateral opacities must be present on a chest radiograph or computerized tomographic (CT) scan. These opacities are not fully explained by pleural effusions, lobar collapse, lung collapse, or pulmonary nodules.
- Respiratory failure not fully explained by cardiac failure or fluid overload.
- Moderate to severe impairment of oxygenation must be present, as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2). The severity of the hypoxemia defines the severity of the ARDS:
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- Moderate ARDS: PaO2/FiO2 >100 mmHg and ≤200 mmHg, on ventilator settings that include PEEP ≥5 cm H2O OR
- Severe ARDS: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm H2O
- High sensitivity C-Reactive Protein (hs-CRP) or CRP serum level >4.0 mg/dL
- Acute Physiologic and Chronic Health Evaluation (APACHE IV) score >5
- Creatinine clearance of ≥ 30 mL/minute OR a creatinine clearance of 20-29 mL/minute with urine output of ≥0.3 mLs/kg/hour over the last 8 hours or ≥500 mLs over the last 24 hours
- The patient or his/her legally authorized representative (LAR) is able to provide informed consent
Who cannot join
- Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV)
- Females who are pregnant or lactating
- Patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia
- Patients with BMI >55
- Patients with untreated HIV infection
- Patients with malignancy who are within 12 months of active treatment with any chemotherapy, radiation or immunotherapy.
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- Patients who have been intubated for more than 72 hours in total at the time of randomization
- Creatinine clearance less than 20 mL/minute or receiving renal replacement therapy
- LFTs (isolated ALT or AST) > 8x upper limit of normal or > 5x upper limit of normal in the setting of other liver function abnormalities (i.e., total bilirubin ≥ 2x upper limit of normal)
- Known hypersensitivity to DMSO or to porcine or bovine proteins
- History of prior respiratory disease with requirement for supplemental oxygen
- Any end-stage organ disease which in the opinion of the investigator may possibly affect the safety of remestemcel-L treatment
- Receiving an investigational cellular therapy agent
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30308
University of Maryland
Baltimore, Maryland, 21201
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Virginia
Charlottesville, Virginia, 22908
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
Lutheran Hospital
Fort Wayne, Indiana, 46825
Dignity Health
Gilbert, Arizona, 85297
Houston Methodist Hospital
Houston, Texas, 77030
Dartmouth-Hitchcock
Lebanon, New Hampshire, 03766
University of Southern California
Los Angeles, California, 90033
Ochsner Clinic
New Orleans, Louisiana, 70121
New York University Langone Health
New York, New York, 10016
Mount Sinai Health
New York, New York, 10029
Northwell Health
New York, New York, 10075
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Baylor, Smith & White
Plano, Texas, 75093
Maine Medical Center
Portland, Maine, 04102
WakeMed
Raleigh, North Carolina, 27610
Stanford University
Stanford, California, 94305
About this study
Official title: Mesenchymal Stromal Cells for the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress Syndrome
The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors reducing the proliferation of pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote resolution of inflammation. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS.
The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.
Read the detailed description
This will be a randomized (1:1 ratio), double blind, parallel design, placebo controlled trial. Randomization will be stratified by clinical center and by moderate versus severe ARDS. The study is designed to have three interim analyses for stopping accrual early for efficacy and futility when 30%, 45% and 60% of the 300 patients have reached the primary endpoint using Bayesian predictive probabilities.
Patients will be randomized in a 1:1 allocation to intravenous infusion of MSCs (remestemcel-L) plus standard of care versus placebo plus standard of care for the treatment of COVID-19 related ARDS:
- Group 1: 2x10^6 MSC/kg of body weight plus standard of care, administered twice during the first week, with the second infusion at 4 days following the first infusion (± 1 day)
- Group 2: Placebo (Plasma-Lyte) plus standard of care, administered twice during the first week, with the second infusion at 4 days following the first infusion (± 1 day) (control)
MSCs and placebo will initially be administered intravenously in the dose defined above at randomization. The rate of infusion may be tailored to the patient's respiratory status and fluid status, but the duration of infusion should not exceed 60 minutes.
Patients will be followed for 90 days post randomization, with assessment of pulmonary symptoms at 6 and 12 months.
- Being tested
- Remestemcel-L, Placebo
- Keywords
- mesenchymal stem cells, SARS-CoV-2, cytokine storm
- Medical subject headings
- Respiratory Distress Syndrome, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remestemcel-LBiological
administered twice during the first week, with the second infusion at 4 days following the first injection (± 1 day)
PlaceboDrug
administered twice during the first week, with second infusion at 4 days following the first injection (± 1 day)
| Study group | Role | What they receive |
|---|---|---|
| Remestemcel-L Plus Standard of Care | Experimental | Intravenous infusion of remestemcel-L 2x10^6 MSC/kg of body weight plus standard of care Receives: Biological: Remestemcel-L |
| Placebo Plus Standard of Care | Placebo comparator | Placebo (Plasma-Lyte) plus standard of care Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of all-cause mortality
Number of all-cause mortality within 30 days of randomization.
Measured: 30 days
Secondary outcomes (40)
Number of days alive off mechanical ventilatory support
Number of days alive off mechanical ventilatory support calculated as the number of days, within the 60 days window, that patients were alive and free of mechanical ventilatory support.
Measured: 60 days
Number of adverse events
Safety analyses will be assessed by adverse event rates calculated as the ratio of the total number of events over 30 days divided by total patient-time at risk for the specific event from randomization.
Measured: 30 days
Number of participants alive at day 7
Measured: 7 days
Number of participants alive at day 14
Measured: 14 days
Number of participants alive at day 60
Measured: 60 days
Number of participants alive at day 90
Measured: 90 days
Number of participants alive at 12 Months
Measured: 12 Months
Number of participants with resolution and/or improvement of ARDS
The number and percent of patients with resolution and/or improvement of ARDS at day 7
Measured: 7 days
Number of participants with resolution and/or improvement of ARDS
The number and percent of patients with resolution and/or improvement of ARDS at day 14
Measured: 14 days
Number of participants with resolution and/or improvement of ARDS
The number and percent of patients with resolution and/or improvement of ARDS at day 21
Measured: 21 days
Number of participants with resolution and/or improvement of ARDS
The number and percent of patients with resolution and/or improvement of ARDS at day 30
Measured: 30 days
Severity of ARDS
severity of ARDS according to Berlin Criteria at days 7 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Measured: baseline and 7 days
Severity of ARDS
severity of ARDS according to Berlin Criteria at days 14 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Measured: baseline and 14 days
Severity of ARDS
severity of ARDS according to Berlin Criteria at days 21 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Measured: baseline and 21 days
Severity of ARDS
severity of ARDS according to Berlin Criteria at days 30 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Measured: baseline and 30 days
Length of stay
Hospital length of stay
Measured: 12 months
Readmissions
number of readmission
Measured: 12 months
Length of Stay in Intensive Care Unit
Measured: 12 months
Clinical Improvement Scale
Change from baseline in Clinical Improvement Scale at day 7. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.
Measured: 7 days
Clinical Improvement Scale
Change from baseline in Clinical Improvement Scale at day 14. Full scale from 1 to 7, with higher score indicating more clinical improvement.
Measured: 14 days
Clinical Improvement Scale
Change from baseline in Clinical Improvement Scale at day 21. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.
Measured: 21 days
Clinical Improvement Scale
Change from baseline in Clinical Improvement Scale at day 30. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.
Measured: 30 days
Change in plasma hs-CRP concentration
Changes from baseline in plasma hs-CRP concentration at days 7
Measured: baseline and 7 days
Change in plasma hs-CRP concentration
Changes from baseline in plasma hs-CRP concentration at days 14
Measured: baseline and 14 days
Change in plasma hs-CRP concentration
Changes from baseline in plasma hs-CRP concentration at days 21
Measured: baseline and 21 days
Change in serum hs-CRP concentration
Changes from baseline in serum hs-CRP concentration at days 30
Measured: baseline and 30 days
Change in IL-6 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 7 days
Measured: baseline and 7 days
Change in IL-6 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 14 days
Measured: baseline and 14 days
Change in IL-6 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 21 days
Measured: baseline and 21 days
Change in IL-6 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 30 days
Measured: baseline and 30 days
Change in IL-8 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 7 days
Measured: baseline and 7 days
Change in IL-8 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 21 days
Measured: baseline and 21 days
Change in IL-8 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 14 days
Measured: baseline and 14 days
Change in IL-8 inflammatory marker level
Changes from baseline in IL-6 inflammatory marker level at 30 days
Measured: baseline and 30 days
Change in TNF-alpha inflammatory marker level
Changes from baseline in TNF-alpha inflammatory marker level at 7 days
Measured: baseline and 7 days
Change in TNF-alpha inflammatory marker level
Changes from baseline in TNF-alpha inflammatory marker level at 14 days
Measured: baseline and 14 days
Change in TNF-alpha inflammatory marker level
Changes from baseline in TNF-alpha inflammatory marker level at 21 days
Measured: baseline and 21 days
Change in TNF-alpha inflammatory marker level
Changes from baseline in TNF-alpha inflammatory marker level at 30 days
Measured: baseline and 30 days
Pulmonary symptoms
including the presence of emphysema, COPD, asthma, pulmonary fibrosis, other pulmonary disease, and the need for respiratory support will be reported by randomization
Measured: 6 months
Pulmonary symptoms
including the presence of emphysema, COPD, asthma, pulmonary fibrosis, other pulmonary disease, and the need for respiratory support will be reported by randomization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start30 Apr 2020
- Primary completion14 Jan 2021
- Study completion2 Jan 2022
Why it stopped: At 3d interim analysis, randomization, but not follow-up, was halted by the DSMB due to low predictive probability of achieving postulated mortality benefit (pre-specified 42.5% relative mortality reduction) were the trial to complete randomization.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenchymal Stromal CellsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized (1:1 ratio), double blind, parallel design, placebo controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Mesoblast, Inc., National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Annetine Gelijns, Icahn School of Medicine at Mount Sinai
- Investigators
- Annetine C Gelijns, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiMichael Mack, MD, Study director, Baylor Research InstitutePeter Smith, MD, Study director, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371393
- Sponsor's protocol ID
- GCO 08-1078-0014
- Status last verified
- Apr 2022
- First submitted
- 28 Apr 2020
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stromal Cells for the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT04371393
- Acronym / sponsor ID
- GCO 08-1078-0014
- Keywords
- mesenchymal stem cells, SARS-CoV-2, cytokine storm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At 3d interim analysis, randomization, but not follow-up, was halted by the DSMB due to low predictive probability of achieving postulated mortality benefit (pre-specified 42.5% relative mortality reduction) were the trial to complete randomization.
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Mesoblast, Inc., National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 2 Jan 2022 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors reducing the proliferation of pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote resolution of inflammation. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS.
The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.
Detailed description
This will be a randomized (1:1 ratio), double blind, parallel design, placebo controlled trial. Randomization will be stratified by clinical center and by moderate versus severe ARDS. The study is designed to have three interim analyses for stopping accrual early for efficacy and futility when 30%, 45% and 60% of the 300 patients have reached the primary endpoint using Bayesian predictive probabilities.
Patients will be randomized in a 1:1 allocation to intravenous infusion of MSCs (remestemcel-L) plus standard of care versus placebo plus standard of care for the treatment of COVID-19 related ARDS:
- Group 1: 2x10^6 MSC/kg of body weight plus standard of care, administered twice during the first week, with the second infusion at 4 days following the first infusion (± 1 day)
- Group 2: Placebo (Plasma-Lyte) plus standard of care, administered twice during the first week, with the second infusion at 4 days following the first infusion (± 1 day) (control)
MSCs and placebo will initially be administered intravenously in the dose defined above at randomization. The rate of infusion may be tailored to the patient's respiratory status and fluid status, but the duration of infusion should not exceed 60 minutes.
Patients will be followed for 90 days post randomization, with assessment of pulmonary symptoms at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a randomized (1:1 ratio), double blind, parallel design, placebo controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Remestemcel-L Plus Standard of Care | Experimental | Biological: Remestemcel-LIntravenous infusion of remestemcel-L 2x10^6 MSC/kg of body weight plus standard of care |
| Placebo Plus Standard of Care | Placebo comparator | Drug: PlaceboPlacebo (Plasma-Lyte) plus standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18 years or older
- Patient has SARS-CoV-2 (COVID-19) confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) assay or other diagnostic test
- Patient requiring mechanical ventilatory support with moderate to severe ARDS as determined by the following criteria (adapted from the Berlin criteria)
- Moderate ARDS: PaO2/FiO2 >100 mmHg and ≤200 mmHg, on ventilator settings that include PEEP ≥5 cm H2O OR
- Severe ARDS: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm H2O
Key exclusion criteria (13 listed)
- Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV)
- Females who are pregnant or lactating
- Patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia
- Patients with BMI >55
- Patients with untreated HIV infection
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 |
|---|---|---|
| Remestemcel-Ladministered twice during the first week, with the second infusion at 4 days following the first injection (± 1 day) | Biological | Remestemcel-L Plus Standard of Care |
| Placeboadministered twice during the first week, with second infusion at 4 days following the first injection (± 1 day) | Drug | Placebo Plus Standard of Care |
Primary outcome
Number of all-cause mortality
Time frame: 30 days
Number of all-cause mortality within 30 days of randomization.
40 secondary outcomes
Number of days alive off mechanical ventilatory support
Time frame: 60 days
Number of adverse events
Time frame: 30 days
Number of participants alive at day 7
Time frame: 7 days
Number of participants alive at day 14
Time frame: 14 days
Number of participants alive at day 60
Time frame: 60 days
Number of participants alive at day 90
Time frame: 90 days
Number of participants alive at 12 Months
Time frame: 12 Months
Number of participants with resolution and/or improvement of ARDS
Time frame: 7 days
Number of participants with resolution and/or improvement of ARDS
Time frame: 14 days
Number of participants with resolution and/or improvement of ARDS
Time frame: 21 days
Number of participants with resolution and/or improvement of ARDS
Time frame: 30 days
Severity of ARDS
Time frame: baseline and 7 days
Severity of ARDS
Time frame: baseline and 14 days
Severity of ARDS
Time frame: baseline and 21 days
Severity of ARDS
Time frame: baseline and 30 days
Length of stay
Time frame: 12 months
Readmissions
Time frame: 12 months
Length of Stay in Intensive Care Unit
Time frame: 12 months
Clinical Improvement Scale
Time frame: 7 days
Clinical Improvement Scale
Time frame: 14 days
Clinical Improvement Scale
Time frame: 21 days
Clinical Improvement Scale
Time frame: 30 days
Change in plasma hs-CRP concentration
Time frame: baseline and 7 days
Change in plasma hs-CRP concentration
Time frame: baseline and 14 days
Change in plasma hs-CRP concentration
Time frame: baseline and 21 days
Change in serum hs-CRP concentration
Time frame: baseline and 30 days
Change in IL-6 inflammatory marker level
Time frame: baseline and 7 days
Change in IL-6 inflammatory marker level
Time frame: baseline and 14 days
Change in IL-6 inflammatory marker level
Time frame: baseline and 21 days
Change in IL-6 inflammatory marker level
Time frame: baseline and 30 days
Change in IL-8 inflammatory marker level
Time frame: baseline and 7 days
Change in IL-8 inflammatory marker level
Time frame: baseline and 21 days
Change in IL-8 inflammatory marker level
Time frame: baseline and 14 days
Change in IL-8 inflammatory marker level
Time frame: baseline and 30 days
Change in TNF-alpha inflammatory marker level
Time frame: baseline and 7 days
Change in TNF-alpha inflammatory marker level
Time frame: baseline and 14 days
Change in TNF-alpha inflammatory marker level
Time frame: baseline and 21 days
Change in TNF-alpha inflammatory marker level
Time frame: baseline and 30 days
Pulmonary symptoms
Time frame: 6 months
Pulmonary symptoms
Time frame: 12 months
Results and safety
The study was stopped early (reason given: At 3d interim analysis, randomization, but not follow-up, was halted by the DSMB due to low predictive probability of achieving postulated mortality benefit (pre-specified 42.5% relative mortality reduction) were the trial to complete randomization.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Annetine C Gelijns, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Michael Mack, MD study director
Baylor Research Institute
Peter Smith, MD study director
Duke University
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remestemcel-L in people with Mesenchymal Stromal Cells and Remestemcel-L, run by Icahn School of Medicine at Mount Sinai at 21 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 13 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: stopped early, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: At 3d interim analysis, randomization, but not follow-up, was halted by the DSMB due to low predictive probability of achieving postulated mortality benefit (pre-specified 42.5% relative mortality reduction) were the trial to complete randomization.). Results are not available in the source record.
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?
Number of all-cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2022; AzTrials last refreshed its copy on 26 Oct 2026.