The purpose of this study is to test the hypothesis that allogeneic Mesenchymal Stem Cells (MSCs) promote systemic and coronary endothelial repair through rescue of bone marrow progenitors in type 2 diabetic patients with symptomatic IHD compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
26
1 single intravenous infusion
Placebo delivered via peripheral intravenous infusion
University of Miami
Miami, Florida, United States
Brachial Artery Flow Mediated Diameter Percentage (FMD%)
FMD% is measured via brachial artery ultrasound. The unit of measure is percent.
Time frame: Baseline, Week 2, Month 1, Month 3, and Month 6
EPC-CFU Counts
Endothelial progenitor cells (EPC)-colony forming units (CFUs) will be assessed from blood samples. The unit of measure is the average number of colonies per well.
Time frame: Baseline, Week 2, Month 1, Month 3, and Month 6
Fractional Flow Reserve (FFR)
Fractional Flow Reserve as assessed by during cardiac catheterization angiography. The values are presented as a ratio.
Time frame: Baseline, Month 6
Coronary Flow Reserve (CFR)
Coronary Flow Reserve as assessed by during cardiac catheterization angiography. The values are presented as a ratio.
Time frame: Baseline, Month 6
Seattle Angina Questionnaire (SAQ) Angina Frequency (AF)
SAQ is a 7 item questionnaire with a total score ranging from 0-100 with the higher scores indicating less physical limitations, less angina, symptom frequency and better quality of life. The unit of measure is score on a scale.
Time frame: Baseline, Week 2, Month 1, Month 3, and Month 6
Seattle Angina Questionnaire (SAQ) Quality of Life (QL)
SAQ is a 7 item questionnaire with a total score ranging from 0-100 with the higher scores indicating less physical limitations, less angina, symptom frequency and better quality of life. The unit of measure is score on a scale.
Time frame: Baseline, Week 2, Month 1, Month 3, and Month 6
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Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)
TE-SAEs will be defined as the composite of: death, non-fatal myocardial infarction (MI), stroke, hospitalization for heart failure, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 30 sec or with hemodynamic compromise) or atrial fibrillation at 1 month post-infusion. TE-SAEs will be assessed by treating physician. The unit of measurement is the number of participants who experienced an event.
Time frame: 1 month post infusion
Number of Participants With Major Adverse Cardiac Events (MACE)
Defined as the composite incidence of (1) death, (2) hospitalization for cardiovascular events or (3) non-fatal myocardial infarction MI at 1 year. MACE will be assessed by treating physician. The unit of measurement is the number of participants who experienced an event.
Time frame: 12 months
Number of Participants With Target Vessel Failure
Number of participants with target vessel failure will be reported. Target vessel failure is defined as any participant that encounters revascularization, death, or MI attributed to the target vessel post-PCI (percutaneous coronary intervention). The unit of measure is number of participants.
Time frame: 12 months
Number of Participants With Treatment Emergent Adverse Events
The number of participants who experienced a Treatment Emergent Adverse Event (AE), as assessed by study physician, will be reported. The unit of measurement is the number of participants who experienced an event.
Time frame: 12 months
Number of Participants With Abnormal Lab Values
Number of participants with clinically significant abnormal serum hematology and clinical chemistry values will be reported. Clinical significance will be assessed by treating physician. The unit of measure is number of participants.
Time frame: 12 months
Circulating Angiogenic Marker - VEGF
Vascular Endothelial Growth Factor (VEGF) levels from serum samples. Results are provided in units of pg/mL. Higher levels of VEGF are associated with better cardiovascular health.
Time frame: Baseline, Month 1, Month 3, Month 6
Circulating Cytokine Biomarker - TNFα
Circulating Tumor necrosis factor alpha (TNFα) levels from serum samples. Results are provided in units of pg/mL. Lower values are associated with reduced inflammation.
Time frame: Baseline, Month 1, Month 3, Month 6