Evaluating Safety and Preventive Effects of StromaForte, a Mesenchymal Stem Cell Treatment, on Cardiovascular Diseases in Adults Aged 25 to 85

What this Trial Is About

This research aims to evaluate the safety and preventive effects of an intravenous infusion of a human allogeneic bone-marrow-derived mesenchymal stromal cell product called StromaForte in adults at risk of cardiovascular diseases CVD. Cardiovascular diseases, including coronary heart disease, stroke, and peripheral artery disease, are leading causes of death worldwide, often developing silently over years. The study explores whether early preventive treatment with these stem cells can reduce inflammation and the risk of cardiovascular events over a long period. Participants will receive a single intravenous infusion of 100 million mesenchymal stromal cells formulated in sodium chloride with human serum albumin, administered slowly over approximately 30 minutes. Additional doses may be given at intervals of three months or more, depending on participant choice and eligibility, to assess potential cumulative benefits. This open-label, single-arm trial follows participants over five years, monitoring cardiovascular health and response to treatment. Throughout the study, participants will undergo regular assessments, including monitoring for adverse events within 28 days post-infusion and tracking cardiovascular events up to five years after treatment. Data collected will include cardiovascular risk evaluations, lifestyle and health questionnaires, and, with consent, medical records and additional blood tests. The study aims to understand both the safety of this treatment and its potential role in preventing cardiovascular disease in a diverse group of adults aged 25 to 85 years.

A Study to Evaluate Mesenchymal Stem Cell Product StromaForte's Effect on Cardiovascular Events