A Prospective, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Combined With HA in Subjects With Moderate to Severe Chronic Low Back Pain
Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants with moderate to severe low back pain for a duration of at least six months who have failed at least 3 months of conservative care.
• Participants who have moderate radiographic degeneration of an intervertebral disc from L1 to S1, with a single disc suspected of causing chronic lower back pain (CLBP).
Locations
United States
Arizona
Axsendo Clinical Research/Summa Pain Care
RECRUITING
Phoenix
California
TriWest Research Associates
RECRUITING
Chula Vista
Boomerang Health Care
RECRUITING
Concord
Memorial Orthopaedic Surgical Group
RECRUITING
Long Beach
Newport Therapeutics
RECRUITING
Newport Beach
University of California-Davis Spine Center
RECRUITING
Sacramento
Innovative Pain Treatment Solutions
RECRUITING
San Diego
University of California-San Francisco
RECRUITING
San Francisco
Source Healthcare
RECRUITING
Santa Monica
Colorado
Colorado Spine Partners/The Denver Spine and Pain Institute
RECRUITING
Greenwood
Florida
Cantor Spine Center at the Paley Orthopedic & Spine Institute
RECRUITING
Fort Lauderdale
New Life Medical Research Center
RECRUITING
Hialeah
Bold City Clinical Research
RECRUITING
Jacksonville
Florida Spine & Pain Specialists
RECRUITING
Riverview
Interventional Pain Institute
RECRUITING
The Villages
Conquest Research LLC
RECRUITING
Winter Park
Georgia
Emory Healthcare
RECRUITING
Dunwoody
Vista Clinical Research
RECRUITING
Newnan
Hawaii
Hawaii Pain & Spine
RECRUITING
Kailua
Idaho
The Pain Centre, Inc.
RECRUITING
Boise
Indiana
Lakeshore Bone and Joint
RECRUITING
Crown Point
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Kentucky
Iqra Research
RECRUITING
Edgewood
Louisiana
Paradigm Health System
RECRUITING
Slidell
Maryland
The Kahan Center
RECRUITING
Annapolis
North Carolina
Eximia EquiHealth Research LLC/Emerge Ortho
RECRUITING
Durham
AdventHealth Hendersonville
RECRUITING
Hendersonville
Nevada
Reno Tahoe Pain Associates
RECRUITING
Reno
New York
University of Rochester
RECRUITING
Rochester
Ohio
Meta Medical Research Institute, LLC
RECRUITING
Dayton
Oklahoma
Clinical Investigations, LLC
RECRUITING
Edmond
Oregon
Axsendo Clinical Research/Compass Pain and Wellness
RECRUITING
Portland
Pennsylvania
OSS Health
RECRUITING
York
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
South Carolina
Clinical Trials of South Carolina
RECRUITING
Charleston
Texas
Institute of Precision Pain Medicine
RECRUITING
Corpus Christi
Paradigm Research Center/Houston Scoliosis and Spine Institute
RECRUITING
Houston
Axsendo Clinical Research/Texas Institute of Pain and Spine
RECRUITING
Pearland
Virginia
VA iSpine Physicians
RECRUITING
Richmond
Contact Information
Primary
Roger D Brown
clinical@mesoblast.com
1 212 880 2060
Time Frame
Start Date: 2024-07-03
Estimated Completion Date: 2027-10
Participants
Target number of participants: 300
Treatments
Experimental: Rexlemestrocel-L + HA
Participants will receive rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with hyaluronic acid (HA) solution on Day 0.
Sham_comparator: Control Group
Participants will receive saline solution as a sham procedure to simulate the active treatment injection on Day 0.
Related Therapeutic Areas
Sponsors
Leads: Mesoblast, Ltd.