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

NCT02412735 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2022-10-19

Study results available
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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

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

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Mesoblast, Ltd.

    lead INDUSTRY

Principal Investigators

  • Roger Brown · Mesoblast, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-06
Primary Completion
2020-05-15
Completion
2021-06-15
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02412735 on ClinicalTrials.gov