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Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathy, Type 2 Diabetes

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

Mesenchymal Precursor Cells (MPCs)

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Diabetic nephropathy, Chronic kidney disease, Metabolic disease, Diabetes mellitus, type 2

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Monash Universtiy
Melbourne Renal Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

Mesenchymal Precursor Cells (MPCs) - Dose 1 or Placebo

Mesenchymal Precursor Cells (MPCs) - Dose 2 or Placebo

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01843387

First Posted

April 23, 2013

Last Updated

October 12, 2016

Sponsor

Mesoblast, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01843387

Brief Title

Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy

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 Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mesoblast, Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This study is taking place in Melbourne, Australia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Nephropathy, Type 2 Diabetes

Keywords

Diabetic nephropathy, Chronic kidney disease, Metabolic disease, Diabetes mellitus, type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Mesenchymal Precursor Cells (MPCs) - Dose 1 or Placebo

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Mesenchymal Precursor Cells (MPCs) - Dose 2 or Placebo

Intervention Type

Biological

Intervention Name(s)

Mesenchymal Precursor Cells (MPCs)

Intervention Description

Single Intravenous Infusion of MPCs Dose 1 or Placebo

Intervention Type

Biological

Intervention Name(s)

Mesenchymal Precursor Cells (MPCs)

Intervention Description

Single Intravenous Infusion of MPCs Dose 2 or Placebo

Primary Outcome Measure Information:

Title

The primary objective of the study is to assess the safety and tolerability of MPC therapy

Description

Time Frame

60 Weeks

Secondary Outcome Measure Information:

Title

Exploratory assessment of the efficacy of MPC therapy

Description

Time Frame

12 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

K Segal, PhD

Organizational Affiliation

Mesoblast, Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Monash Universtiy

City

Clayton

Country

Australia

Facility Name

Melbourne Renal Research Group

City

Melbourne

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

27743903

Citation

Packham DK, Fraser IR, Kerr PG, Segal KR. Allogeneic Mesenchymal Precursor Cells (MPC) in Diabetic Nephropathy: A Randomized, Placebo-controlled, Dose Escalation Study. EBioMedicine. 2016 Oct;12:263-269. doi: 10.1016/j.ebiom.2016.09.011. Epub 2016 Sep 17.

Results Reference

derived

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Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy

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