Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 Infection
NCT04366830 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2021-02-18
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
Interventions
- 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).
Sponsors & Collaborators
-
Mesoblast International Sàrl
lead INDUSTRY
Principal Investigators
-
Elizabeth Burke, ANP-C · Mesoblast, Inc.
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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