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

PHASE3CompletedINTERVENTIONAL
Enrollment

404

Participants

Timeline

Start Date

March 6, 2015

Primary Completion Date

May 15, 2020

Study Completion Date

June 15, 2021

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

Trial Locations (48)

3168

Monash Medical Center, Clayton

10022

Ainsworth Institute of Pain Management, New York

14626

Rochester Regional Health, Rochester

17402

Orthopaedic and Spine Specialists, York

20037

George Washington University Medical Center, Washington D.C.

23235

Virginia iSpine Physicians, PC, Richmond

27103

The Center for Clinical Research/ Carolinas Pain Institute, Winston-Salem

28117

On Site Clinical Solutions, LLC, Morrisville

28204

Carolina Neurosurgery and Spine Associates, Charlotte

29406

Clinical Trials of South Carolina, Charleston

Greenville Pharmaceutical Research, Inc., Charleston

30060

Georgia Institute for Clinical Research, LLC, Marietta

30329

Emory Orthopaedics & Spine Center, Atlanta

32034

Coastal Clinical Research Specialists, Fernandina Beach

33316

Shrock Orthopedic Research, LLC, Fort Lauderdale

33334

Holy Cross Orthopedics Institute, Oakland Park

35235

Alabama Clinical Therapeutics, LLC, Birmingham

35801

Tennessee Valley Pain Consultants, Huntsville

41017

Otrimed Clinical Research, Edgewood

44106

Cleveland Clinic, Cleveland

45432

DOC Clinical Research, Dayton

55379

MAPS Applied Research Center, Shakopee

55905

Mayo Clinic, Rochester

61701

Millennium Pain Center, Bloomington

71103

Orthopedic Specialists of Louisiana, Shreveport

73013

Clinical Investigations, LLC, Edmond

75093

Texas Back Institute, Plano

75701

Precision Spine Care, Tyler

76092

Spine Team Texas, Southlake

80111

Denver Back Pain Specialists, LLC, Greenwood Village

83713

Injury Care Medical Center, Boise

84010

Ericksen Research & Development, LLC, Bountiful

84020

the SMART Clinic, Draper

84790

Hope Research Institute, St. George

85258

Arizona Pain Specialists, Scottsdale

89129

Innovative Pain Care Center, Las Vegas

90403

Orthopedic Pain Specialists, Santa Monica

The Spine Institute, Santa Monica

90806

Memorial Orthopaedics Surgical Group, Long Beach

91105

Institute for Regenerative Medicine and Clinical Research, Pasadena

92660

Newport Beach Headache and Pain, Newport Beach

94598

Integrated Pain Management, Walnut Creek

95401

Summit Pain Alliance, Santa Rosa

95816

UC Davis Spine Center, Sacramento

85284-2604

Physicians Research Group, Tempe

92020-4124

TriWest Research Associates, LLC, El Cajon

08873

University Clinical Research, Somerset

02903

RI Hospital-Comprehensive Spine Center, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

lead

Mesoblast, Ltd.

INDUSTRY