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
EPC-CFU levels
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: 6 months post-infusion
Flow Mediated Diameter Percentage (FMD%)
FMD% is measured via brachial artery ultrasound. The unit of measure is percent.
Time frame: 6 months post-infusion
Target lesion lumen loss
Target lesion lumen loss as assessed by quantitative coronary angiography (QCA). The unit of measure is millimeters (mm).
Time frame: 6 months (post-infusion)
Circulating angiogenic factors marker levels
Circulating angiogenic marker levels will be assessed from blood samples. The unit of measure is pg/mL
Time frame: 6 months post-infusion
Circulating inflammatory markers
Circulating inflammatory markers including will be assessed from blood samples. The unit of measure is pg/mL.
Time frame: 6 months post-infusion
Seattle Angina Questionnaire (SAQ) Angina Frequency
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: 6 months post-infusion
EuroQol 5 Dimension (EQ-5D) Quality of life Questionnaire Overall Health Status Question
EQ-5D Quality of Life Questionnaire Overall Health Status question has a total score ranging from 0-100 with higher scores indicating better quality of life. The unit of measure is score on a scale.
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Time frame: 6 months post-infusion
Short Form (SF) 36 Questionnaire Quality of Life Questionnaire
SF 36 Quality of Life Questionnaire consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a score on an scale of 0-100. Lower scores indicate the more disability, and higher scores indicate less disability.
Time frame: 6 months post-infusion
Number of 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 measure is number of events.
Time frame: 1 month post infusion
Number of 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 measure is number of events
Time frame: 12 months
Number of Treatment Emergent Adverse Events
Rates of treatment emergent adverse event (AE) as assessed by treating physician will be reported. The unit of measure is number of events.
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
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. The unit of measure is number of participants.
Time frame: 12 months
Post-Percutaneous Coronary Intervention (PCI) coronary artery endothelial function as assessed via CFR
Coronary Flow Reserve (CFR) as measured via cardiac catheterization angiography. The value is expressed as a ratio that is calculated by dividing the maximum coronary blood flow (mL/min/g) by the resting blood flow (mL/min/g)
Time frame: 6 months (post-infusion)
Post-PCI coronary artery endothelial function as assessed via FFR
Fractional Flow Reserve (FFR) as measured via cardiac catheterization angiography. FFR is a dimensionless number that ranges from 0 to 1 that is a ratio of two pressures (mmHg).
Time frame: 6 months (post infusion)