Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy

October 12, 2016 updated by: Mesoblast, Ltd.

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.

Study Overview

Detailed Description

This study is taking place in Melbourne, Australia.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Clayton, Australia
        • Monash Universtiy
      • Melbourne, Australia
        • Melbourne Renal Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

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
Time Frame: 60 Weeks

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
Time Frame: 12 Weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: K Segal, PhD, Mesoblast, Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

April 25, 2013

First Posted (Estimate)

April 30, 2013

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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