Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes

Mesoblast

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Mesenchymal Precursor Cells (MPCs)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01576328

MSB-DM003

Details and patient eligibility

About

This study is being conducted to assess the overall safety and tolerability of a single intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects with Type 2 Diabetes inadequately controlled on Metformin.

Enrollment: 61 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male and female subjects who are ≥ 18 and ≤ 80 years old
• Subjects diagnosed with type 2 diabetes at least one year prior to Screening and receiving a stable, therapeutic dose of metformin > 1500 mg/day according to local prescribing information for at least 3 months prior to Screening or the highest tolerated dose > 1000 mg/day documented in the subject's history
• HbA1c > 7.0% and < 10.5% at Screening
• C-peptide > 0.8 ng/mL at Screening
• Body mass index (BMI) > 22 and < 45 kg/m2 at Screening
• Body weight < 150 kg at Screening

Key Exclusion Criteria:

• Prior participation in any stem cell study
• Women who are pregnant, intending to become pregnant during the study period or currently lactating
• History of active substance abuse (including alcohol) within the past 2 years. Current alcohol abuse is defined as daily consumption of >3 alcoholic beverage. Current cigarette smoking > 10 cigarettes per day
• Severe hypoglycemia (defined as requiring third party assistance) or repeated and/or frequent hypoglycemia episodes (> 2 episodes/week) within one month prior to Screening
• Patients receiving treatment for type 2 diabetes with diet and exercise alone, insulin therapy within 6 months of Screening except if used transiently for < 7 days for intercurrent illness or any other anti-diabetic medication except metformin within 3 months of Screening
• Any concurrent medical condition/disorder or clinically symptomatic cardiovascular, gastrointestinal (including pancreatitis), renal, hematological, pulmonary, acute or chronic infectious disease, active retinal disease, or other disorder which in the Investigator's opinion would interfere with the subject's ability to complete the trial, would require administration of treatment that could affect the interpretation of the safety and efficacy variables or would preclude safe involvement in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 3 patient groups

Cohort 1

Experimental group

Description:

MPC dose 1 or Placebo

Treatment:

Drug: Mesenchymal Precursor Cells (MPCs)

Drug: Mesenchymal Precursor Cells (MPCs)

Drug: Mesenchymal Precursor Cells (MPCs)

Cohort 2

Experimental group

Description:

MPC dose 2 or Placebo

Treatment:

Drug: Mesenchymal Precursor Cells (MPCs)

Drug: Mesenchymal Precursor Cells (MPCs)

Drug: Mesenchymal Precursor Cells (MPCs)

Cohort 3

Experimental group

Description:

MPC dose 3 or Placebo

Treatment:

Drug: Mesenchymal Precursor Cells (MPCs)

Drug: Mesenchymal Precursor Cells (MPCs)

Drug: Mesenchymal Precursor Cells (MPCs)