drugset / Trial / NCT01290367

Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain

NCT01290367 ↗

Phase 2 Completed 100 enrolled Mesoblast, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back pain due to moderate Degenerative Disc Disease (DDD) at one lumbar level from L1 to S1. All investigational subjects in this study will undergo injection of either 6 million (M) or 18M cells in a hyaluronic acid carrier into the degenerated lumbar disc's nucleus pulposus. All control subjects will undergo an intradiscal control injection with either saline or hyaluronic acid only

Timeline

Start
2011-08
Primary completion
2013-07
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Mesenchymal Precursor Cells Cell therapy 6 cells Other
Subject Mesenchymal Precursor Cells Cell therapy 18 cells Other