Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy

A Randomized, Controlled, Dose-Escalation Pilot Study to Assess the Safety and Efficacy of a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Diabetic Nephropathy and Type 2 Diabetes

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.

Inclusion Criteria:

• Men and women who are ≥ 50 and ≤ 85 years old
• Subjects diagnosed with type 2 diabetes at least 2 years prior to Screening
• Subjects with diabetic nephropathy and CKD stage 3b-4
• Albumin-to-creatinine ratio (ACR) from a spot urine sample >30 and < 3000 mg/g at Screening
• Subjects must be receiving standard of care treatment for their diabetic nephropathy with an angiotensin converting enzyme inhibitor (ACEi) and/or an angiotensin II receptor blocker (ARB) for at least 12 weeks prior to Screening.
• HbA1c < 10.0% at Screening

Exclusion Criteria:

• Prior participation in any stem cell study
• Women of childbearing potential
• Potentially unreliable subjects and those judged by the Investigator to be unsuitable for the study
• History of active substance abuse (including alcohol) within the past 2 years. Current alcohol abuse is defined as daily consumption of >3 alcoholic beverages (i.e. > 21 alcoholic beverages per week)
• Body weight >150 kg
• Subjects with non-diabetic renal disease e.g. known polycystic kidney disease
• Subjects with a history of a renal transplant or who have had prior dialysis within 3 months of Screening and/or have not maintained a stable level of kidney function within 3 months of Screening
• Current or history within 6 months of Screening of NYHA Class III or IV heart failure
• Myocardial infarction or stroke within 6 months prior to Screening
• Any concurrent medical condition/disorder or clinically symptomatic cardiovascular, gastrointestinal, hematological, pulmonary, acute or chronic infectious disease, active retinal disease or other disorder which in the Investigator's opinion would interfere with the subjects ability to complete the trial, would require administration of treatment that could affect the interpretation of the efficacy and safety variables or would preclude safe involvement in the study