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NCT Number: NCT06325566

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Axsendo Clinical Research/Summa Pain Care, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.
  • Participants with a full thickness annular tear observed on magnetic resonance imaging (MRI) or discography.
  • Participants with low back pain that is less than moderate in severity.
  • Participants with extreme low back pain.
  • Participants who lack moderate to extreme functional limitations/disability.

Note: Other exclusion criteria may apply.

Treatment and study plan

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.

Saline

Drug

Saline solution injection adjacent to the index disc.

Primary outcomes

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

    Time frame: Baseline and Month 12

    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.

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

    Time frame: Up to Month 24

Secondary outcomes

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

    Time frame: Month 12

    Responders are defined as participants who have at least a 30% decrease from baseline in daily average low back pain VAS score (measured as the average VAS score over 7 days). VAS score ranges from 0 (no pain) to 100 (worst possible pain).

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

    Time frame: Baseline and Month 12

    The EQ-5D is a generic instrument that consists of 5 dimensions: Mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression, rated over five levels of severity ranging from no issues to extreme issues and the responses can be converted into a single number called an index score. The index scores are calculated ranging from 0 (worst quality of life) to 1 (perfect quality of life).

  3. Percentage of Minimal Pain Responders at 12 Months Post-treatment

    Time frame: Month 12

    Minimal pain responders are defined as participants who have a low back pain daily average VAS score (measured as the average VAS score over 7 days) of 20 mm or less. VAS score ranges from 0 (no pain) to 100 (worst possible pain).

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

    Time frame: Baseline and Month 12

    ODI scores ten aspects of the participant's home and work life and analgesic use in a range of 0 (least amount of disability) to 5 (severe disability). The disability index is then calculated by summing the scores for all questions answered, then multiplied by two and reported in a 0 to 100% range where higher numbers indicate a higher level of disability.

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

    Time frame: Month 12

    Treatment success based on the percentage of participants who have at least a 30% reduction from baseline in daily average low back pain VAS score (measured as the average VAS score over 7 days) with at least a 10-point decrease from baseline ODI score will be reported.

  6. Percentage of Participants Who Ceased Opioid Usage at 24 Months Post-treatment

    Time frame: Month 24

Sponsors and collaborators

Lead sponsor

Mesoblast, Ltd.

Industry

Registry information

Official study 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

Acronym: HyaluronicAcid

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 22, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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