81
Participants
Start Date
November 18, 2018
Primary Completion Date
August 5, 2025
Study Completion Date
February 3, 2026
Low Dose Mesenchymal Stem Cells (MSCs)
Participants will receive a single IV infusion of Mesenchymal Stem Cells (MSCs) 1 x 10\^6 cells/kg in Plasma-Lyte A solution. All participants will receive the infusion at the Baseline (Day 0) visit. All participants will continue on their standard-of-care therapy during the trial.
High Dose Mesenchymal Stem Cells (MSCs)
Participants will receive a single IV infusion of Mesenchymal Stem Cells MSCs 5 x 10\^6 cells/kg in Plasma-Lyte A solution.
Placebo Infusion
Participants will receive a placebo infusion that does not contain any mesenchymal stem cells.The placebo infusion will consist of Plasma-Lyte A, which is the same vehicle used to deliver the MSCs in the experimental groups.
The Feinstein Institute for Medical Research, Manhasset
University of Rochester Medical Center, Rochester
University of North Carolina at Chapel Hill, Chapel Hill
Medical University of South Carolina, Charleston
Emory University, Atlanta
Northwestern University, Chicago
Oklahoma Medical Research Foundation, Oklahoma City
Cedars-Sinai Medical Center, Los Angeles
University of California - San Diego, San Diego
Medical University of South Carolina
OTHER