MSCs in COVID-19 ARDS

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Mesenchymal Stromal Cells, Remestemcel-L, Acute Respiratory Distress Syndrome, COVID

In brief

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.

Key facts

Study ID

NCT04371393

Run by

Icahn School of Medicine at Mount Sinai

People needed

223

Starts

2020-04-30

Expected to finish

2022-01-02

Last updated by the study team

2022-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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

You may not qualify if…

• 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.
• 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

Where it is running

• Dignity Health — Gilbert, Arizona, United States
• University of Southern California — Los Angeles, California, United States
• Stanford University — Stanford, California, United States
• Emory University — Atlanta, Georgia, United States
• Lutheran Hospital — Fort Wayne, Indiana, United States
• Ochsner Clinic — New Orleans, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• University of Maryland — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Dartmouth-Hitchcock — Lebanon, New Hampshire, United States
• New York University Langone Health — New York, New York, United States
• Mount Sinai Health — New York, New York, United States
• Northwell Health — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• WakeMed — Raleigh, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Baylor, Smith & White — Plano, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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