Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 Infection

NCT04366830 | Unknown

• 1 other identifier: MSB-MSC-ARDS001
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with ARDS due to coronavirus infection 2019 (COVID-19).

Conditions

Moderate to Severe Acute Respiratory Distress Syndrome Associated With COVID-19

Keywords

ARDS; COVID-19; Coronavirus; MSC; remestemcel-L; Mesoblast; mesenchymal

Interventions

Remestemcel-L DRUG

Participants will receive remestemcel-L in two infusions of 2 x 10\^6 mesenchymal stromal cells per kilogram (MSC/kg), administered intravenously (IV).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Participant has coronavirus disease COVID-19 confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) assay or another diagnostic test
• 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 computed 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. An objective assessment (e.g., echocardiography) to exclude hydrostatic pulmonary edema is required if no risk factors for ARDS are present.
• 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: e PaO2/FiO2 \>100 millimeters of mercury (mmHg) and ≤200 mmHg, on ventilator settings that include positive end-expiratory pressure (PEEP) ≥5 centimeters (cm) of water OR
• Severe ARDS: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm of water
• ≤72 hours post-initiation of ventilation
• High sensitivity C-reactive protein (hs-CRP) serum level ≥ 4.0 milligrams per deciliter (mg/dL)
• Acute Physiologic and Chronic Health Evaluation (APACHE II) score ≥5
• Aspartate aminotransferase/alanine transaminase (AST/ALT) \< 5x upper limit of normal (ULN)
• Creatinine clearance ≥ 30 milliliters per minute (mL/min)
• Serum creatinine \<2 mg/dL

You may not qualify if:

• Participant is receiving extracorporeal membrane oxygenation (ECMO)
• Females who are pregnant or lactating
• Known hypersensitivity to dimethyl sulfoxide (DMSO) or to porcine or bovine proteins
• Severe chronic obstructive pulmonary disease (COPD) requiring oxygen therapy prior to becoming ill with ARDS due to COVID-19 infection
• Any end-stage organ disease which, in the opinion of the treating physician, may possibly affect the safety of the remestemcel-L treatment

Sponsors & Collaborators

• Mesoblast International Sàrl: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

remestemcel-l

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Elizabeth Burke, ANP-C

  Mesoblast, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 29, 2020
• Last Updated: February 18, 2021

Record last verified: 2020-04

Locations

US (1)