drugset / Trial / NCT04466098

Multiple Dosing of Mesenchymal Stromal Cells in Patients With ARDS (COVID-19)

NCT04466098

Phase 2 Completed 8 enrolled Masonic Cancer Center, University of Minnesota
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a multi-center, randomized, placebo controlled, interventional phase 2A trial to evaluate the safety profile and potential efficacy of multi-dosing of mesenchymal stromal cells (MSC) for patients with SARS-CoV-2 associated Acute Respiratory Distress Syndrome (ARDS). After informed consent, treatment assignment will be made by computer-generated randomization to administer either MSC or vehicle placebo control with a 2:1 allocation to the MSC: placebo arm.

Timeline

Start
2020-07-30
Primary completion
2022-02-25
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject mesenchymal stem cells Cell therapy 3e+08 cells