Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
This study is taking place in Melbourne, Australia.

Official Title
-----------------
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

Conditions
-----------------
Diabetic Nephropathy, Type 2 Diabetes

Intervention / Treatment
-----------------
* Biological: Mesenchymal Precursor Cells (MPCs)
* Biological: Mesenchymal Precursor Cells (MPCs)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Mesenchymal Precursor Cells (MPCs) - Dose 1 or Placebo | Biological: Mesenchymal Precursor Cells (MPCs)<br>* Single Intravenous Infusion of MPCs Dose 1 or Placebo<br>|
| Experimental: Cohort 2<br>Mesenchymal Precursor Cells (MPCs) - Dose 2 or Placebo | Biological: Mesenchymal Precursor Cells (MPCs)<br>* Single Intravenous Infusion of MPCs Dose 2 or Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 60 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic nephropathy, Chronic kidney disease, Metabolic disease, Diabetes mellitus, type 2