A Study to Evaluate Mesenchymal Stem Cell Product StromaForte's Effect on Cardiovascular Events - Trial NCT06087848

Timeline & Enrollment

Primary Outcome

To evaluate the number of adverse events or severe adverse event assessed by Common Terminology Criteria For Adverse Events (CTCAE) of intravenous infusion of human allogeneic BM-derived MSCs product StromaForte for all study participants.

Summary

The goal of this phase I/II clinical trial is to evaluate the safety and preventive effect of
 intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product
 StromaForte in study participants. The main questions it aims to answer are:
 
 To assess the safety and tolerability after 28 days of injection by reporting the number of
 adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE) To evaluate
 the effects of Mesenchymal stem cells on Prevention of Cardiovascular Events by following the
 reported incidence of cardiovascular events amongst study participants up to five year
 post-injection Participants will receive 100 x 106 allogeneic bone marrow (BM)-derived
 Mesenchymal Stromal Cell (MSC) formulated in sodium chloride supplemented with human serum
 albumin to be given via slow intravenous infusion 100 million cells in approximately 30 min

ICD-10 Classifications