NCT04366830

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

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

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Mesoblast International Sàrl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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).

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.

Conditions

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

Interventions

Type	Name	Description
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).

Timeline

• First posted: 2020-04-29
• Last updated: 2021-02-18

Locations

1 site across 1 country: United States