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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06325566
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mesoblast, Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Roger D Brown
Principal Investigator Affiliation	Mesoblast, Ltd.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Degenerative Disc Disease

Arms & Interventions

Arms

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.

Interventions

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.

Drug: - Saline

Saline solution injection adjacent to the index disc.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix 5308655, Arizona 5551752

Status

Recruiting

Address

Axsendo Clinical Research/Summa Pain Care

Phoenix 5308655, Arizona 5551752, 85085

Site Contact

Paul Pannozzo, MD

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