Rexlemestrocel-L + HA for Lower Back Pain

(HyaluronicAcid Trial)

Recruiting at 23 trial locations

Overseen By Christopher James

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Mesoblast, Ltd.

Must not be taking: Immunosuppressants

Disqualifiers: Osteoporosis, Substance abuse, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking systemic immunosuppressants.

How is the treatment Rexlemestrocel-L + HA unique for lower back pain?

Rexlemestrocel-L + HA is unique because it combines a cellular therapy (Rexlemestrocel-L) with hyaluronic acid (HA), potentially offering a novel approach by targeting inflammation and tissue repair, unlike standard pain medications that primarily focus on symptom relief. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Roger D Brown

Principal Investigator

Mesoblast, Ltd.

Eligibility Criteria

This trial is for people with moderate to severe chronic low back pain that's lasted at least six months, despite trying other treatments for three months. They should have signs of disc degeneration in the lower spine but only one disc causing the pain.

Inclusion Criteria

I have had severe low back pain for over 6 months and treatments haven't worked.

I have moderate back disc degeneration suspected to cause my chronic lower back pain.

Exclusion Criteria

I have received stem cell therapy or biological treatment for my spinal disc before.

Participants with alcohol or substance abuse problems

I have a specific spine condition affecting my lower back.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of rexlemestrocel-L combined with HA or a saline solution as a sham procedure on Day 0

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 12 months post-treatment

12 months

Treatment Details

Interventions

• Rexlemestrocel-L

Trial Overview The study tests if a single injection of Rexlemestrocel-L mixed with HA can reduce back pain after 12 months compared to a saline control. Participants will be randomly assigned to receive either the treatment or placebo.

Participant Groups

Group I: Rexlemestrocel-L + HA Experimental Treatment 1 Intervention

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.

Group II: Control Group Placebo Group 1 Intervention

Participants will receive saline solution as a sham procedure to simulate the active treatment injection on Day 0.

Who Is Running the Clinical Trial?

Mesoblast, Ltd.

Lead Sponsor

Trials

14

Recruited

1,100+

Findings from Research

In a study of 60 patients with nonspecific low back pain, a combination therapy including amelotex, calmirex, and kompligamB resulted in significantly greater pain relief and improved functional status compared to monotherapy with amelotex alone.

The combination therapy not only reduced pain more effectively but also led to more significant improvements in inflammatory markers, suggesting a comprehensive approach to treating low back pain is beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The assessment of efficacy and tolerability of the complex therapy of low back pain]. Shavlovskaya, OA., Romanov, ID.[2020]

In a study of 444 participants with chronic low back pain, those with widespread pain experienced significantly higher levels of pain-related interference and psychosocial issues, such as anxiety and depression, compared to those with localized low back pain.

Participants with peripheral neuropathic back pain showed similar characteristics to those with widespread pain, suggesting that these subgroups may require tailored treatment approaches based on their specific pain-related factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain-related interference and pain-related psychosocial factors of three different subgroups of patients with chronic low back pain. Corrêa, LA., Bittencourt, JV., Mathieson, S., et al.[2023]

In a study of 45 patients with degenerative lumbar spine disease, those who underwent surgery showed significant improvement in low back pain (LBP) after one year, although pain levels remained higher than pre-surgery levels after an average follow-up of 5.5 years.

Factors such as improved sagittal spinal balance, instrumentation at the third or fourth vertebrae, and being male were associated with greater reductions in LBP, suggesting that surgical strategies focusing on these aspects may enhance postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of sagittal spinal balance, levels of posterior instrumentation, and length of follow-up on low back pain in patients undergoing posterior decompression and instrumented fusion for degenerative lumbar spine disease: a multifactorial analysis. Korovessis, P., Repantis, T., Papazisis, Z., et al.[2019]

In chronic low back pain (LBP), combination pharmacotherapy significantly improves pain relief and function compared to both placebo and monotherapy, based on a review of 12 randomized controlled trials.

However, combination pharmacotherapy does not show superior effectiveness in acute LBP and carries a higher risk of adverse effects compared to both placebo and monotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Combination Pharmacotherapy on Low Back Pain: A Meta-analysis. Song, L., Qiu, P., Xu, J., et al.[2019]

Real-time ultrasound imaging is a reliable method for assessing the activation of the transverse abdominis (TrA) muscle in patients with low back pain, showing high reliability scores above 0.93.

While both traditional training and training with ultrasound biofeedback led to a significant increase in TrA thickness during the abdominal drawing-in maneuver, the biofeedback did not improve performance, suggesting that further research is needed to identify specific patient subgroups that might benefit from this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of ultrasound imaging of the abdominal drawing-in maneuver in subjects with low back pain. Teyhen, DS., Miltenberger, CE., Deiters, HM., et al.[2022]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The assessment of efficacy and tolerability of the complex therapy of low back pain]. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Pain-related interference and pain-related psychosocial factors of three different subgroups of patients with chronic low back pain. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of sagittal spinal balance, levels of posterior instrumentation, and length of follow-up on low back pain in patients undergoing posterior decompression and instrumented fusion for degenerative lumbar spine disease: a multifactorial analysis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The Effect of Combination Pharmacotherapy on Low Back Pain: A Meta-analysis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The use of ultrasound imaging of the abdominal drawing-in maneuver in subjects with low back pain. [2022]