Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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This study is taking place in Melbourne, Australia.

Conditions

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Diabetic Nephropathy Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cohort 1

Mesenchymal Precursor Cells (MPCs) - Dose 1 or Placebo

Group Type EXPERIMENTAL

Mesenchymal Precursor Cells (MPCs)

Intervention Type BIOLOGICAL

Single Intravenous Infusion of MPCs Dose 1 or Placebo

Cohort 2

Mesenchymal Precursor Cells (MPCs) - Dose 2 or Placebo

Group Type EXPERIMENTAL

Mesenchymal Precursor Cells (MPCs)

Intervention Type BIOLOGICAL

Single Intravenous Infusion of MPCs Dose 2 or Placebo

Interventions

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Mesenchymal Precursor Cells (MPCs)

Single Intravenous Infusion of MPCs Dose 1 or Placebo

Intervention Type BIOLOGICAL

Mesenchymal Precursor Cells (MPCs)

Single Intravenous Infusion of MPCs Dose 2 or Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No