Phase II Trial of Intravenous Umbilical Cord-Derived Mesenchymal Stromal Cells to Treat Septic Shock in ICU Patients

What this Trial Is About

Septic shock is a severe infection causing cardiovascular collapse and organ failure, with high rates of death and long-term disability for survivors. Researchers are evaluating the use of mesenchymal stromal cells MSCs derived from umbilical cord tissue as a potential treatment. This phase II randomized controlled trial UC-CISS II aims to assess clinical effectiveness, safety, biomarkers, and economic impact of MSC therapy in patients with septic shock in intensive care units across Canada. Participants will be randomly assigned to receive an intravenous infusion of either 300 million allogeneic, cryopreserved umbilical cord-derived MSCs or a placebo. The trial is double-blind, meaning neither participants nor researchers know the assigned treatment. The study plans to enroll 296 patients over about 2.5 years at several academic centers. Treatments are given once shortly after randomization during the intensive care stay. During the study, patients will be monitored for up to one year for outcomes including days free from mechanical ventilation, vasopressors, or renal replacement therapy, organ failure rates, mortality, length of hospital and ICU stays, and hospital readmissions. Biomarkers related to vascular permeability, kidney injury, muscle weakness, infection clearance, and inflammation will be measured at baseline and several days after treatment. Safety is closely tracked through adverse event reporting. Patient function and quality of life will be assessed at 30 days, 6 months, and 1 year post-treatment. A health economic analysis will also be conducted through 28 days post-randomization.

Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock