Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes

Phase 1/2 Completed 61 enrolled Mesoblast, Inc.

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2012-04
Primary completion: 2013-10
Completion: 2015-10

Publications

Skyler JS, Fonseca VA, Segal KR, Rosenstock J; MSB-DM003 Investigators. Allogeneic Mesenchymal Precursor Cells in Type 2 Diabetes: A Randomized, Placebo-Controlled, Dose-Escalation Safety and Tolerability Pilot Study. Diabetes Care. 2015 Sep;38(9):1742-9. doi: 10.2337/dc14-2830. Epub 2015 Jul 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rexlemestrocel-L	Cell therapy	0.3 cells/kg	Intravenous
Subject	Rexlemestrocel-L	Cell therapy	1 cells/kg	Intravenous
Subject	Rexlemestrocel-L	Cell therapy	2 cells/kg	Intravenous

Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes

Summary

Timeline

Publications

Drugs

Indications