Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy

Mesoblast

Status and phase

Completed

Phase 2

Phase 1

Conditions

Diabetic Nephropathy

Type 2 Diabetes

Treatments

Biological: Mesenchymal Precursor Cells (MPCs)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01843387

MSB-DN001

Details and patient eligibility

About

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.

Full description

This study is taking place in Melbourne, Australia.

Enrollment

30 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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