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

February 17, 2021 updated by: Mesoblast International Sàrl

Intermediate-size Expanded Access of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells for Acute Respiratory Distress Syndrome Due to COVID-19 Infection

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).

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

This intermediate-size expanded access protocol plans to treat approximately 50 adult participants, male and female, with moderate to severe ARDS due to COVID-19 infection. Participants who are 18 years of age or older will be enrolled at multiple clinical sites across the United States.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population
  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 years or older
  2. Participant has coronavirus disease COVID-19 confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) assay or another diagnostic test

  3. 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
  4. ≤72 hours post-initiation of ventilation
  5. High sensitivity C-reactive protein (hs-CRP) serum level ≥ 4.0 milligrams per deciliter (mg/dL)
  6. Acute Physiologic and Chronic Health Evaluation (APACHE II) score ≥5
  7. Aspartate aminotransferase/alanine transaminase (AST/ALT) < 5x upper limit of normal (ULN)
  8. Creatinine clearance ≥ 30 milliliters per minute (mL/min)
  9. Serum creatinine <2 mg/dL

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mesoblast International Sàrl

Investigators

  • Study Director: Elizabeth Burke, ANP-C, Mesoblast, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSB-MSC-ARDS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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