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

April 23, 2013
January 7, 2014
July 2013
September 2014   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01843387 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetic Nephropathy
  • Type 2 Diabetes
  • Biological: Mesenchymal Precursor Cells (MPCs)
    Single Intravenous Infusion of MPCs Dose 1 or Placebo
  • Biological: Mesenchymal Precursor Cells (MPCs)
    Single Intravenous Infusion of MPCs Dose 2 or Placebo
  • Experimental: Cohort 1
    Mesenchymal Precursor Cells (MPCs) - Dose 1 or Placebo
    Intervention: Biological: Mesenchymal Precursor Cells (MPCs)
  • Experimental: Cohort 2
    Mesenchymal Precursor Cells (MPCs) - Dose 2 or Placebo
    Intervention: Biological: Mesenchymal Precursor Cells (MPCs)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
September 2015
September 2014   (final data collection date for primary outcome measure)

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
Both
50 Years to 85 Years
No
Contact: K Segal, PhD 212-880-2060 karen.segal@mesoblast.com
Australia
 
NCT01843387
MSB-DN001
Yes
Mesoblast, Ltd.
Mesoblast, Ltd.
Not Provided
Not Provided
Mesoblast, Ltd.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP