CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 404 enrolled
Drug / intervention
Rexlemestrocel-L +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02412735
NCT02412735Phase 3Completed
CompareCT.gov

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

Mesoblast, Ltd.·interventional·Posted Apr 9, 2015·Updated Oct 19, 2022

In Brief

A Phase 3 clinical trial evaluating Rexlemestrocel-L, Rexlemestrocel-L + HA Mixture, and 1 other intervention for Degenerative Disc Disease. Completed, enrolled 404 participants across 48 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDegenerative Disc Disease
CountriesAustralia, United States
CollaboratorsQuintiles, Inc.

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 9, 2015
Enrollment StartMar 6, 2015
Primary CompletionMay 15, 2020
Study CompletionJun 15, 2021
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 11.2 years ago

Interventions

Rexlemestrocel-Ldrug

Rexlemestrocel-L injection

Rexlemestrocel-L + HA Mixturedrug

Rexlemestrocel-L was combined in 1:1 by-volume ratio with HA solution and the resulting mixture was injected

Placebodrug

Saline control solution