NCT02412735

Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain

A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Alone or Combined With Hyaluronic Acid (HA) in Subjects With Chronic Low Back Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: Mesoblast, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in participants with chronic low back pain (\> 6 months) associated with moderate radiographic degenerative changes of a disc.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DRUG	Rexlemestrocel-L	Rexlemestrocel-L injection
DRUG	Rexlemestrocel-L + HA Mixture	Rexlemestrocel-L was combined in 1:1 by-volume ratio with HA solution and the resulting mixture was injected
DRUG	Placebo	Saline control solution

Timeline

• Start date: 2015-03-06
• Primary completion: 2020-05-15
• Completion: 2021-06-15
• First posted: 2015-04-09
• Last updated: 2022-10-19
• Results posted: 2022-01-18

Locations

48 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study