Completed
Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) Safety and Efficacy in Diabetic Nephropathy and Type 2 Diabetes
Study Aim
This study aims to evaluate the safety and tolerability of a single intravenous infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in individuals with Diabetic Nephropathy and Type 2 Diabetes, monitoring adverse events, vital signs, physical examinations, and clinical laboratory tests.
What is being tested
Mesenchymal Precursor Cells (MPCs)
+ Mesenchymal Precursor Cells (MPCs)
Biological
Who is being recruted
Urogenital Diseases+17
+ Chronic Disease
+ Diabetes Mellitus
From 50 to 85 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1 & 2
Interventional
Study Start: July 2013
Summary
Principal SponsorMesoblast, Ltd.
Last updated: October 14, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2013
Actual date on which the first participant was enrolled.This study is taking place in Melbourne, Australia.
Principal SponsorMesoblast, Ltd.
Last updated: October 14, 2016
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 50 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesChronic DiseaseDiabetes MellitusEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesGlucose Metabolism DisordersDiabetes ComplicationsRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesDiabetes Mellitus, Type 2Diabetic NephropathiesMetabolic DiseasesRenal Insufficiency, Chronic
Criteria
6 inclusion criteria required to participate
Albumin-to-creatinine ratio (ACR) from a spot urine sample > 30 and < 3000 mg/g at Screening
HbA1c < 10.0% at Screening
Men and women who are >= 50 and <= 85 years old
Subjects diagnosed with type 2 diabetes at least 2 years prior to Screening
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10 exclusion criteria prevent from participating
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
Body weight > 150 kg
Current or history within 6 months of Screening of NYHA Class III or IV heart failure
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)
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalMesenchymal Precursor Cells (MPCs) - Dose 1 or Placebo
Group II
ExperimentalMesenchymal Precursor Cells (MPCs) - Dose 2 or Placebo
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Melbourne Renal Research Group
Melbourne, AustraliaCompleted2 Study Centers