Clinical trial NCT01843387: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Nephropathy
Type 2 Diabetes
Keywords: Diabetic nephropathy
Chronic kidney disease
Metabolic disease
Diabetes mellitus, type 2
Lead sponsor: Mesoblast, Ltd.
Sponsor class: INDUSTRY
First posted: 2013-04-30
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary objective of the study is to assess the safety and tolerability of MPC therapy
timeFrame: 60 Weeks
Secondary outcomes:
measure: Exploratory assessment of the efficacy of MPC therapy
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Monash Universtiy
city: Melbourne
country: Australia
facility: Melbourne Renal Research Group
Study officials:
affiliation: Mesoblast, Ltd.
name: K Segal, PhD
role: STUDY_DIRECTOR
References:
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.