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

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ClinicalTrials.gov Identifier: NCT04366830
Expanded Access Status : No longer available
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )

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).

Condition or disease Intervention/treatment
Moderate to Severe Acute Respiratory Distress Syndrome Associated With COVID-19 Drug: Remestemcel-L

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.

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population, Treatment IND/Protocol
Official Title: 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



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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366830


Locations
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United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
Sponsors and Collaborators
Mesoblast International Sàrl
Investigators
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Study Director: Mahboob Rahman, MD Mesoblast, Inc.
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Responsible Party: Mesoblast International Sàrl
ClinicalTrials.gov Identifier: NCT04366830    
Other Study ID Numbers: MSB-MSC-ARDS001
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Keywords provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):
ARDS
COVID-19
Coronavirus
MSC
remestemcel-L
Mesoblast
mesenchymal
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury