This study is being conducted to assess the overall safety and tolerability of a single intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects with Type 2 Diabetes inadequately controlled on Metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
61
Single intravenous infusion of MPCs Dose 1
Single intravenous infusion of MPCs Dose 2
Single intravenous infusion of MPCs Dose 3
SC Clinical Research
Garden Grove, California, United States
Diabetes Research Institute
Miami, Florida, United States
Primary objective of the study is to assess the safety and tolerability of MPC therapy
Outcomes include the measurement of the following safety parameters: * Adverse events and serious adverse events(including hypoglycemia) * Vital signs (BP, HR, RR, O2 saturation) * Physical examinations * Results of clinical laboratory tests (hematology, biochemistry, and urinalysis, flow cytometry Class I and Class II PRA % with specificity, antibovine and antimurine antibody analysis) * Pulmonary function test * Electrocardiograms * Chest X-ray * Fundus oculi examination
Time frame: 116 Weeks
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