NCT01576328

Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes

A Randomized, Placebo-Controlled Dose-Escalation Study to Assess the Safety and Tolerability of a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients With Type 2 Diabetes Sub-optimally Controlled on Metformin

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Mesoblast, Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Mesenchymal Precursor Cells (MPCs)	Single intravenous infusion of MPCs Dose 1
DRUG	Mesenchymal Precursor Cells (MPCs)	Single intravenous infusion of MPCs Dose 2
DRUG	Mesenchymal Precursor Cells (MPCs)	Single intravenous infusion of MPCs Dose 3

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-10-01
• Completion: 2015-10-01
• First posted: 2012-04-12
• Last updated: 2020-06-02

Locations

18 sites across 1 country: United States