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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01843387




Registration number
NCT01843387
Ethics application status
Date submitted
23/04/2013
Date registered
30/04/2013
Date last updated
14/10/2016

Titles & IDs
Public title
Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy
Scientific 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
Secondary ID [1] 0 0
MSB-DN001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Nephropathy 0 0
Type 2 Diabetes 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Mesenchymal Precursor Cells (MPCs)
Treatment: Other - Mesenchymal Precursor Cells (MPCs)

Experimental: Cohort 1 - Mesenchymal Precursor Cells (MPCs) - Dose 1 or Placebo

Experimental: Cohort 2 - Mesenchymal Precursor Cells (MPCs) - Dose 2 or Placebo


Treatment: Other: Mesenchymal Precursor Cells (MPCs)
Single Intravenous Infusion of MPCs Dose 1 or Placebo

Treatment: Other: Mesenchymal Precursor Cells (MPCs)
Single Intravenous Infusion of MPCs Dose 2 or Placebo
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective of the study is to assess the safety and tolerability of MPC therapy
Timepoint [1] 0 0
60 Weeks
Secondary outcome [1] 0 0
Exploratory assessment of the efficacy of MPC therapy
Timepoint [1] 0 0
12 Weeks

Eligibility
Key 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
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Universtiy - Clayton
Recruitment hospital [2] 0 0
Melbourne Renal Research Group - Melbourne
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mesoblast, Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01843387
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
K Segal, PhD
Address 0 0
Mesoblast, Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01843387