Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain

NCT06325566 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: MSB-DR004
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 40

Brief 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.

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (2)

• Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score

  Low back pain intensity will be measured using a VAS ranging from 0-100 millimeter (mm). A score of 0 represents no pain and 100 represents worst possible pain.

  Baseline and Month 12

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to Month 24

Secondary Outcomes (6)

• Percentage of 30% VAS Pain Responders at 12 Months Post-treatment

  Month 12

• Mean Change From Baseline in Quality of Life Measured by Euroqol-5D (EQ-5D) Index Score at 12 Months Post-treatment

  Baseline and Month 12

• Percentage of Minimal Pain Responders at 12 Months Post-treatment

  Month 12

• Mean Change From Baseline in Function as Measured by Oswestry Disability Index (ODI) Questionnaire Score at 12 Months Post-treatment

  Baseline and Month 12

• Percentage of Participants With 30% VAS and 10-point ODI Treatment Success at 12 Months Post-treatment

  Month 12

Study Arms (2)

Rexlemestrocel-L + HA

EXPERIMENTAL

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.

Drug: Rexlemestrocel-L + HA mixture

Control Group

SHAM COMPARATOR

Participants will receive saline solution as a sham procedure to simulate the active treatment injection on Day 0.

Drug: Saline

Interventions

Rexlemestrocel-L + HA mixture DRUG

Rexlemestrocel-L will be combined in 1:1 by-volume ratio with HA solution and the resulting mixture will be administered as intradiscal injection.

Rexlemestrocel-L + HA

Saline DRUG

Saline solution injection adjacent to the index disc.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Participants who have been a recipient of prior allogeneic stem cell/progenitor cell therapy for any indication or autologous stem cell/progenitor cell therapy or other biological intervention to repair the index intervertebral disc.
• Participants with low back pain duration of less than 6 months or greater than 60 months.
• Participants who have not received at least 3 months of conservative treatment for back pain without adequate pain relief.
• Participants taking systemic immunosuppressants.
• Participants with osteoporosis.
• Participants with alcohol or substance abuse problems.
• Participants with severe depression or anxiety.
• Participants with cauda equina syndrome; fibromyalgia, symptomatic central vertebral canal stenosis, lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc.
• Participants having undergone a surgical procedure affecting the structure/biomechanics of the disc (e.g., discectomy, intradiscal electrothermal therapy, intradiscal radiofrequency, artificial disc replacement, interbody fusion, laminectomy, etc.) at the index or adjacent levels.
• Participants who have received any lumbar intradiscal injection into the index disc or adjacent discs within three months prior to the start of screening, other than injection of contrast medium for discography.
• Participants who received an epidural steroid injection within 6 weeks prior to informed consent.
• Participants with evidence of neurologic deficit on any component of the lumbar neurological exam at baseline.
• Participants with sacroiliac (SI) joint pain, as determined by a targeted physical exam, or SI joint injection.
• Participants with facet joint pain, as determined by a medial branch block.
• Participants with more than a single painful level.

Sponsors & Collaborators

• Mesoblast, Ltd.: lead

Study Sites (40)

Axsendo Clinical Research/Summa Pain Care

Phoenix, Arizona, 85085, United States

Location

Pain Institute of Southern Arizona

Tucson, Arizona, 85710, United States

Location

TriWest Research Associates

Chula Vista, California, 91910, United States

Location

Boomerang Health Care

Concord, California, 94520, United States

Location

Apex Research Group

Fair Oaks, California, 95628, United States

Location

Memorial Orthopaedic Surgical Group

Long Beach, California, 90806, United States

Location

Newport Therapeutics

Newport Beach, California, 92660, United States

Location

University of California-Davis Spine Center

Sacramento, California, 95816, United States

Location

Innovative Pain Treatment Solutions

San Diego, California, 92111, United States

Location

University of California-San Francisco

San Francisco, California, 94143, United States

Location

Source Healthcare

Santa Monica, California, 90403, United States

Location

Colorado Spine Partners/The Denver Spine and Pain Institute

Greenwood, Colorado, 80111, United States

Location

Cantor Spine Center at the Paley Orthopedic & Spine Institute

Fort Lauderdale, Florida, 33306, United States

Location

New Life Medical Research Center

Hialeah, Florida, 33012, United States

Location

Bold City Clinical Research

Jacksonville, Florida, 32224, United States

Location

Interventional Pain Institute

The Villages, Florida, 32162, United States

Location

Conquest Research LLC

Winter Park, Florida, 32789, United States

Location

Emory Healthcare

Dunwoody, Georgia, 30338, United States

Location

Vista Clinical Research

Newnan, Georgia, 30265, United States

Location

Hawaii Pain & Spine

Kailua, Hawaii, 96734, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Iqra Research

Edgewood, Kentucky, 41017, United States

Location

Paradigm Health System

Slidell, Louisiana, 70458, United States

Location

The Kahan Center

Annapolis, Maryland, 21401, United States

Location

Elevate Clinical Research

Rockville, Maryland, 20852, United States

Location

Oasis Clinical Research

Las Vegas, Nevada, 89121, United States

Location

Reno Tahoe Pain Associates

Reno, Nevada, 89511, United States

Location

University of Rochester

Rochester, New York, 14611, United States

Location

Eximia EquiHealth Research LLC/Emerge Ortho

Durham, North Carolina, 27704, United States

Location

AdventHealth Hendersonville

Hendersonville, North Carolina, 28792, United States

Location

Meta Medical Research Institute, LLC

Dayton, Ohio, 45432, United States

Location

Clinical Investigations, LLC

Edmond, Oklahoma, 73034, United States

Location

OSS Health

York, Pennsylvania, 17402, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Institute of Precision Pain Medicine

Corpus Christi, Texas, 78414, United States

Location

Paradigm Research Center/Houston Scoliosis and Spine Institute

Houston, Texas, 77030, United States

Location

Axsendo Clinical Research/Texas Institute of Pain and Spine

Pearland, Texas, 77584, United States

Location

VA iSpine Physicians

Richmond, Virginia, 23238, United States

Location

West Virginia University

Martinsburg, West Virginia, 25401, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Roger D Brown

  Mesoblast, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 22, 2024
• Study Start: July 3, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (40)