This is a 16 subject trial to demonstrate the safety of allogeneic hMSCs administered via infusion therapy for diabetic subjects with endothelial dysfunction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
1 single intravenous infusion
1 single intravenous infusion
University of Miami Miller School of Medicine
Miami, Florida, United States
Number of Treatment Emergent Serious Adverse Events (TE-SAEs)
TE-SAEs as evaluated by the investigator which may include but not limited to: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
Time frame: Up to one month (post infusion)
EPC-CFU Levels
Endothelial Progenitor Cell Colony Forming Units (EPC-CFU) will be assessed from blood samples
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
CRP Marker Levels
C-Reactive Protein (CRP) levels will be assessed from blood samples and reported in mg/L
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Circulating Angiogenic Factor Levels
Circulating Angiogenic Factor levels including Vascular Endothelial Growth Factor (VEGF), Stem Cell Factor (SCF) and Stromal Cell-Derived Factor 1 (SDF-1) will be assessed from blood samples and reported in ng/mL
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Flow Mediated Diameter Percentage (FMD%)
FMD will be assessed using brachial artery ultrasound
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Circulating Inflammatory Marker Levels
Circulating inflammatory marker levels including Interleukin (IL) -1 and IL-6 will be assessed from blood samples and reported in pg/mL
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
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Tumor Necrosis Factor (TNF) Alpha Levels
Measured from blood samples (pg/mL)
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365