Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Mesoblast, Ltd.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd.
ClinicalTrials.gov Identifier:
NCT01843387
First received: April 23, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Diabetic Nephropathy
Type 2 Diabetes
Biological: Mesenchymal Precursor Cells (MPCs)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Mesoblast, Ltd.:

Primary Outcome Measures:
  • The primary objective of the study is to assess the safety and tolerability of MPC therapy [ Time Frame: 60 Weeks ] [ Designated as safety issue: Yes ]

    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)


Secondary Outcome Measures:
  • Exploratory assessment of the efficacy of MPC therapy [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 30
Study Start Date: July 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Mesenchymal Precursor Cells (MPCs) - Dose 1 or Placebo
Biological: Mesenchymal Precursor Cells (MPCs)
Single Intravenous Infusion of MPCs Dose 1 or Placebo
Experimental: Cohort 2
Mesenchymal Precursor Cells (MPCs) - Dose 2 or Placebo
Biological: Mesenchymal Precursor Cells (MPCs)
Single Intravenous Infusion of MPCs Dose 2 or Placebo

Detailed Description:

This study is taking place in Melbourne, Australia.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01843387

Contacts
Contact: K Segal, PhD 212-880-2060 karen.segal@mesoblast.com

Locations
Australia
Monash Universtiy Recruiting
Clayton, Australia
Melbourne Renal Research Group Recruiting
Melbourne, Australia
Sponsors and Collaborators
Mesoblast, Ltd.
  More Information

No publications provided

Responsible Party: Mesoblast, Ltd.
ClinicalTrials.gov Identifier: NCT01843387     History of Changes
Other Study ID Numbers: MSB-DN001
Study First Received: April 23, 2013
Last Updated: January 7, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Mesoblast, Ltd.:
Diabetic nephropathy
Chronic kidney disease
Metabolic disease
Diabetes mellitus, type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on July 20, 2014