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
Willing and able to provide written informed consent and comply with all procedures required by the protocol.
Aged ≥ 25 to 85 years at the time of signing the informed consent form.
Subjects with pre-morbid or stable morbid medical conditions, not requiring significant changes to their current medical therapy for > 6 months prior to enrolling in this study, are eligible
Unwilling or unable to perform any of the assessments required by the protocol.
Have end stage liver or renal disease.
Have a clinical history of malignancy within 2.5 years (i.e., study participants with prior malignancy must be cancer free for 2.5 years) except curatively treated basal cell carcinoma, melanoma in situ, or cervical carcinoma.
Have any condition that limits lifespan to < 1 year according to the Principal Investigator's discretion.