RECRUITING

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

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Conditions

Degenerative Disc Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-03
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06325566

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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).
  1. * 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.
  2. * Participants with low back pain duration of less than 6 months or greater than 60 months.
  3. * Participants who have not received at least 3 months of conservative treatment for back pain without adequate pain relief.
  4. * Participants taking systemic immunosuppressants.
  5. * Participants with osteoporosis.
  6. * Participants with alcohol or substance abuse problems.
  7. * Participants with severe depression or anxiety.
  8. * Participants with cauda equina syndrome; fibromyalgia, symptomatic central vertebral canal stenosis, lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc.
  9. * 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.
  10. * 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.
  11. * Participants who received an epidural steroid injection within 6 weeks prior to informed consent.
  12. * Participants with evidence of neurologic deficit on any component of the lumbar neurological exam at baseline.
  13. * Participants with sacroiliac (SI) joint pain, as determined by a targeted physical exam, or SI joint injection.
  14. * Participants with facet joint pain, as determined by a medial branch block.
  15. * Participants with more than a single painful level.
  16. * Participants with a full thickness annular tear observed on magnetic resonance imaging (MRI) or discography.
  17. * Participants with low back pain that is less than moderate in severity.
  18. * Participants with extreme low back pain.
  19. * Participants who lack moderate to extreme functional limitations/disability.

Contacts and Locations

Study Contact

David Nunez
CONTACT
1 212 880 2060
clinical@mesoblast.com

Principal Investigator

Roger D Brown
STUDY_DIRECTOR
Mesoblast, Ltd.

Study Locations (Sites)

Alabama Ortho, Spine and Sports, PC
Birmingham, Alabama, 35235
United States
Premier Surgery Center
Concord, California, 94520
United States
Source Healthcare
Santa Monica, California, 90403
United States
Bold City Clinical Research
Jacksonville, Florida, 32224
United States
Meta Medical Research Institute, LLC
Dayton, Ohio, 45432
United States
Clinical Investigations, LLC
Edmond, Oklahoma, 73034
United States

Collaborators and Investigators

Sponsor: Mesoblast, Ltd.

  • Roger D Brown, STUDY_DIRECTOR, Mesoblast, Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-03
Study Completion Date2027-10

Study Record Updates

Study Start Date2024-07-03
Study Completion Date2027-10

Terms related to this study

Additional Relevant MeSH Terms

  • Degenerative Disc Disease