Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy

NCT01843387 | Completed Phase 1 DMC

• 1 other identifier: MSB-DN001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Nephropathy; Type 2 Diabetes

Keywords

Diabetic nephropathy; Chronic kidney disease; Metabolic disease; Diabetes mellitus, type 2

Outcome Measures

Primary Outcomes (1)

• The primary objective of the study is to assess the safety and tolerability of MPC therapy

  Outcomes include the following safety parameters: * Number of and percent of subject with adverse events and serious adverse events * Clinically significant values and shifts from baseline in vital signs, physical examinations and electrocardiograms * Clinical laboratory tests (hematology, chemistry and urinalysis, flow cytometry with Class I and Class II PRA % with specificity)

  60 Weeks

Secondary Outcomes (1)

• Exploratory assessment of the efficacy of MPC therapy

  12 Weeks

Study Arms (2)

Cohort 1

EXPERIMENTAL

Mesenchymal Precursor Cells (MPCs) - Dose 1 or Placebo

Biological: Mesenchymal Precursor Cells (MPCs)

Cohort 2

EXPERIMENTAL

Mesenchymal Precursor Cells (MPCs) - Dose 2 or Placebo

Biological: Mesenchymal Precursor Cells (MPCs)

Interventions

Mesenchymal Precursor Cells (MPCs) BIOLOGICAL

Single Intravenous Infusion of MPCs Dose 1 or Placebo

Cohort 1

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mesoblast, Ltd.: lead

Study Sites (2)

Monash Universtiy

Clayton, Australia

Location

Melbourne Renal Research Group

Melbourne, Australia

Location

Related Publications (1)

• 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.

  PMID: 27743903 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; Metabolic Diseases

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• K Segal, PhD

  Mesoblast, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 30, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

AU (2)