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.
Single group
Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte)
Biological/Vaccine100 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 in approximately 30 min
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.
To assess the safety of injection by reporting the number of adverse events or severe adverse event assessed by Common Terminology Criteria For Adverse Events (CTCAE) which is the Incidence of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities determined per the Investigator's judgment.
To evaluate the effects of MSCs on Prevention of Cardiovascular Events
The secondary endpoint of this study is to evaluate the reported incidence of cardiovascular events among the study participants. Cardiovascular events include but are not limited to myocardial infarction (heart attack), stroke, coronary artery disease, heart failure, and peripheral arterial disease. By monitoring and documenting the occurrence of these events, the study aims to assess the impact of the intervention (e.g., treatment with mesenchymal stem cells) on reducing the overall burden of cardiovascular events in the study population.
Incidence of Diabetes
The exploratory endpoint of this study is to evaluate the reported incidence of diabetes among the study participants. By monitoring and documenting the occurrence of new cases of diabetes during the study period, the objective is to assess the potential influence of the intervention on the development or progression of diabetes in the study population.
Incidence of Arthritis
The exploratory endpoint of this study is to evaluate the reported incidence of arthritis among the study participants. By monitoring and documenting the occurrence of new cases of arthritis during the study period, the objective is to assess the potential influence of the intervention on the development or progression of arthritis in the study population.
Changes in Blood Glucose levels
Changes from baseline in Blood Glucose levels to 5 years
Changes in serum glucose levels
Changes from baseline in serum glucose levels to 5 years
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