Active — Not RecruitingPhase 3

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

United States300 participantsStarted 2024-07-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 3 trial testing an injection called rexlemestrocel-L combined with hyaluronic acid directly into the disc — how does that approach compare to what's currently considered standard treatment for my level of degenerative disc disease?
2The trial is no longer enrolling new participants, so even if this specific study isn't an option for me, are there similar trials or treatments using rexlemestrocel-L that I might still be able to access?
3Since the main thing they're measuring at 12 months is pain reduction on a scale called the VAS, what would a meaningful improvement actually look like in real life for someone at my stage, and how does that compare to what other treatments have shown?
4The trial is also tracking serious adverse events — what are the known or suspected risks of injecting a cell-based therapy like this directly into a spinal disc, and how would those risks weigh against my current situation?
5Given that this is a Phase 3 study, meaning it's further along in testing than earlier phases, what does my doctor think the existing evidence shows about whether this treatment is ready to be considered alongside or instead of other options I haven't tried yet?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline and Month 12

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

Timeframe: Up to Month 24

Trial details

NCT IDNCT06325566

SponsorMesoblast, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07

View on ClinicalTrials.gov More Degenerative Disc Disease trials