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Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01843387
Recruitment Status : Completed
First Posted : April 30, 2013
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd.

Study Description
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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.

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

Detailed Description:
This study is taking place in Melbourne, Australia.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : July 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843387


Locations
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Australia
Monash Universtiy
Clayton, Australia
Melbourne Renal Research Group
Melbourne, Australia
Sponsors and Collaborators
Mesoblast, Ltd.
Investigators
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Study Director: K Segal, PhD Mesoblast, Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mesoblast, Ltd.
ClinicalTrials.gov Identifier: NCT01843387    
Other Study ID Numbers: MSB-DN001
First Posted: April 30, 2013    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
Keywords provided by Mesoblast, Ltd.:
Diabetic nephropathy
Chronic kidney disease
Metabolic disease
Diabetes mellitus, type 2
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications