The study investigates the safety, tolerability and efficacy of a single intravenous infusion of two doses of mesenchymal precursor cells versus placebo in subjects with diabetic nephropathy and type 2 diabetes.
This study is taking place in Melbourne, Australia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Single Intravenous Infusion of MPCs Dose 1 or Placebo
Single Intravenous Infusion of MPCs Dose 2 or Placebo
Monash Universtiy
Clayton, Australia
Melbourne Renal Research Group
Melbourne, Australia
The primary objective of the study is to assess the safety and tolerability of MPC therapy
Outcomes include the following safety parameters: * Number of and percent of subject with adverse events and serious adverse events * Clinically significant values and shifts from baseline in vital signs, physical examinations and electrocardiograms * Clinical laboratory tests (hematology, chemistry and urinalysis, flow cytometry with Class I and Class II PRA % with specificity)
Time frame: 60 Weeks
Exploratory assessment of the efficacy of MPC therapy
Outcomes include changes from baseline at 12 weeks in the following parameters: * Renal function (glomerular filtration rate, renal blood flow) * Serum creatinine * Urinary albumin and protein excretion * Glycemic control * Biomarkers
Time frame: 12 Weeks
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