A Randomized Blinded Placebo Controlled Clinical Trial to Evaluate Longeveron Mesenchymal Stem Cell LMSC Therapy for Treating The Metabolic Syndrome

The metabolic syndrome MetS is a cluster of factors that increases the risks for cardiovascular disease type diabetes mellitus and mortality and currently affects andgt of US adults MetS is associated with endothelial dysfunction decreased circulating endothelial progenitor cells EPCs and a pro inflammatory state We have made the exciting discovery that therapy with allogeneic mesenchymal stem cells MSCs restores endothelial dysfunction and circulating EPCs towards normal the levels and reduces markers of inflammation Endothelial function represents a key driver of cardiovascular morbidity and mortality in MetS and as such restoring endothelial function could lead to clinical benefits in this patient population We will conduct a clinical trial using Longeveron produced allogeneic mesenchymal stem cells LMSCs delivered to subjects with MetS In Phase I of this study we will perform a dose escalation Safety Run In to first establish safety of LMSC therapy in subjects with MetS After a safety review and approval from an independent data safety monitoring board DMSB Phase II of this Fast Track Study will commence This will entail a Randomized Double Blinded Placebo Controlled Phase on subjects with MetS The following specific aims will be examined Specific Aim To test the hypothesis that LMSCs are safe to intravenously administer to subjects with MetS We will examine for incidence of treatment emergent serious adverse events TE SAEs blood chemistry hematology coagulation and urinalysis and alloimmune reaction and T and B cell subsets to examine levels of immune activation Specific Aim To test the hypothesis that intravenously administered LMSCs will improve endothelial dysfunction and increase circulating EPCs in subjects with MetS We will examine endothelial dysfunction using flow mediated vasodilation FMD and circulating EPCs by colony assays and flow cytometry Specific Aim To test the hypothesis that intravenously administered LMSCs will improve systemic markers of inflammation in subjects with MetS We will use ELISA to examine panels of inflammatory markers Specific Aim To test the hypothesis that intravenously administered LMSCs will lead to clinical improvement in subjects with MetS We will examine for changes in glucose control hemoglobin A c fasting glucose fasting insulin HOMA lipid profile HDL LDL triglycerides cholesterol blood pressure and cardiac function physical performance and subject quality of life We anticipate that the results of this study will lead to a much needed therapeutic for subjects with MetS Longeveron is positioned to rapidly advance this program to a pivotal phase III trial if the results prove positive and to bring this technology to market The metabolic syndrome MetS is a cluster of factors that increases the risks for cardiovascular disease type diabetes mellitus and mortality MetS currently affects over of US adults and has reached epidemic proportions worldwide yet highly effective treatments are not available In this study a clinical trial will be conducted in which we will use cell therapy to treat MetS www ClinicalTrials gov identifier NCT This therapeutic is unique in that it targets major contributors to MetS endothelial dysfunction diminished endothelial progenitor cells and increased inflammation and we anticipate will provide a highly effective and much needed treatment for MetS