- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01843387
Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy
October 12, 2016 updated by: Mesoblast, Ltd.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is taking place in Melbourne, Australia.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Clayton, Australia
- Monash Universtiy
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Melbourne, Australia
- Melbourne Renal Research Group
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
Mesenchymal Precursor Cells (MPCs) - Dose 1 or Placebo
|
Single Intravenous Infusion of MPCs Dose 1 or Placebo
Single Intravenous Infusion of MPCs Dose 2 or Placebo
|
Experimental: Cohort 2
Mesenchymal Precursor Cells (MPCs) - Dose 2 or Placebo
|
Single Intravenous Infusion of MPCs Dose 1 or Placebo
Single Intravenous Infusion of MPCs Dose 2 or Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
60 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory assessment of the efficacy of MPC therapy
Time Frame: 12 Weeks
|
Outcomes include changes from baseline at 12 weeks in the following parameters:
|
12 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: K Segal, PhD, Mesoblast, Ltd.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
April 23, 2013
First Submitted That Met QC Criteria
April 25, 2013
First Posted (Estimate)
April 30, 2013
Study Record Updates
Last Update Posted (Estimate)
October 14, 2016
Last Update Submitted That Met QC Criteria
October 12, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSB-DN001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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