Phase 2Withdrawn
Safety and Efficacy Trial Using Allogeneic Human Mesenchymal Stem Cells: The SIRONA Trial
A Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety and Efficacy of Allogeneic Human Mesenchymal Stem Cells in Patients With Metabolic Syndrome.
- Sponsor
- Longeveron Inc. (Industry)
- Conditions
- Metabolic Disease; Endothelial Dysfunction
- Interventions
- Peripheral Intravenous (IV) infusion of LMSCs
- Ages
- adults, older adults
- Registry
- NCT02587572
From the registry
This is a phase 2b, randomized, placebo-controlled clinical trial designed to evaluate the safety and efficacy of Longeveron Mesenchymal Stem Cells (LMSCs) in subjects with metabolic syndrome and to assess the effects of LMSCs on endothelial function using several different doses.
Primary outcomes
- Endothelial function: Changes in endothelial function as assessed by the following: