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

Degenerative Disc Disease Clinical Trial

— HyaluronicAcid  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06325566
• Other study ID #: MSB-DR004
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2024
• Est. completion date: August 2027

Study information

• Verified date: March 2024
• Source: Mesoblast, Ltd.
• Contact: David Nunez
• Phone: 512-826-8897
• Email: clinical[@]mesoblast.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Low Back Pain

Intervention

Drug:
• Rexlemestrocel-L + HA mixture
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
Saline solution injection adjacent to the index disc.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mesoblast, Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to Month 24
Secondary	Percentage of 30% VAS Pain Responders at 12 Months Post-treatment	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).	Month 12
Secondary	Mean Change From Baseline in Quality of Life Measured by Euroqol-5D (EQ-5D) Index Score at 12 Months Post-treatment	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).	Baseline and Month 12
Secondary	Percentage of Minimal Pain Responders at 12 Months Post-treatment	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).	Month 12
Secondary	Mean Change From Baseline in Function as Measured by Oswestry Disability Index (ODI) Questionnaire Score at 12 Months Post-treatment	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.	Baseline and Month 12
Secondary	Percentage of Participants With 30% VAS and 10-point ODI Treatment Success at 12 Months Post-treatment	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.	Month 12
Secondary	Percentage of Participants Who Ceased Opioid Usage at 24 Months Post-treatment		Month 24