Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843387
• Other study ID #: MSB-DN001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 23, 2013
• Last updated: October 12, 2016
• Start date: July 2013
• Est. completion date: September 2015

Study information

• Verified date: October 2016
• Source: Mesoblast, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

This study is taking place in Melbourne, Australia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases
• Type 2 Diabetes

Intervention

Biological:
• Mesenchymal Precursor Cells (MPCs)
Single Intravenous Infusion of MPCs Dose 1 or Placebo
• Mesenchymal Precursor Cells (MPCs)
Single Intravenous Infusion of MPCs Dose 2 or Placebo

Locations

Country	Name	City	State
Australia	Monash Universtiy	Clayton
Australia	Melbourne Renal Research Group	Melbourne

Sponsors (1)

Lead Sponsor	Collaborator
Mesoblast, Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No