Rexlemestrocel-L + HA for Lower Back Pain

(HyaluronicAcid Trial)

Recruiting at 46 trial locations

Overseen By Roger D Brown

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, rexlemestrocel-L (a type of cell therapy), combined with hyaluronic acid (HA), to determine if it reduces lower back pain more effectively than a placebo (inactive treatment). The focus is on individuals with moderate to severe low back pain for at least six months who haven't found relief from other treatments. Participants will receive a single injection into the spine's lumbar discs and will be monitored for pain changes over 12 months. Ideal candidates have a specific type of disc degeneration causing their chronic back pain. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising new treatment.

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.

Is there any evidence suggesting that rexlemestrocel-L + HA is likely to be safe for humans?

Research has shown that rexlemestrocel-L, when combined with hyaluronic acid (HA), has been tested for safety in people. In earlier studies, most patients tolerated this treatment well, with serious side effects being rare. Most side effects, if they occurred, were mild and temporary, such as slight pain or swelling at the injection site. The treatment's progression to a later testing phase indicates some confidence in its safety for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for lower back pain, which often include medications like NSAIDs, opioids, or physical therapy, rexlemestrocel-L offers a unique approach by using stem cells. Researchers are excited about this treatment because it involves injecting approximately 6 million rexlemestrocel-L cells mixed with hyaluronic acid directly into the affected area, potentially promoting healing and reducing inflammation at the source. This targeted, cell-based therapy could provide longer-lasting relief and address the underlying causes of pain rather than just masking the symptoms.

What evidence suggests that rexlemestrocel-L + HA could be an effective treatment for lower back pain?

In this trial, participants will receive either rexlemestrocel-L combined with hyaluronic acid (HA) or a saline solution as a sham procedure. Studies have shown that combining rexlemestrocel-L with HA may reduce chronic low back pain, especially in individuals with degenerative disc disease. Patients who used this treatment reported long-lasting pain relief. Research suggests that this treatment reduces inflammation and aids in healing damaged discs. While the results are promising, further studies are needed to confirm its long-term effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

Roger D Brown

Principal Investigator

Mesoblast, Ltd.

Are You a Good Fit for This Trial?

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

My MRI shows I have a full thickness tear in my spinal disc.

Participants with alcohol or substance abuse problems

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06325566

NCT06325566 | Efficacy and Safety of Rexlemestrocel-L ... 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.

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/lower-back-pain

Lower Back Pain clinical trials at UCSF 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 ...

3. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/back-pain

Back Pain Clinical Trials This research study is designed to evaluate the efficacy of Tuina therapy (Chinese massage therapy) compared to physiotherapy for low back pain. A Study to ...

4. sourcehealthcare.com sourcehealthcare.com/clinical-trials/currently-enrolling/mesoblast-phase-iii-clinical-trial/

Mesoblast Phase III Clinical Trial | Source Santa Monica, CA This innovative treatment aims to provide lasting relief for patients suffering from chronic low back pain caused by degenerative disc disease.

5. trials.arthritis.org trials.arthritis.org/trials/NCT06325566

Efficacy and Safety of Rexlemestrocel-L Combined With HA ... 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 ...

6. ctv.veeva.com ctv.veeva.com/study/efficacy-and-safety-of-rexlemestrocel-l-combined-with-ha-in-participants-with-moderate-to-severe-ch

Efficacy and Safety of Rexlemestrocel-L Combined With HA ... 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.

7. mayo.edu mayo.edu/research/clinical-trials/cls-20201312

Clinical Trials ... Safety of a Single Injection of Rexlemestrocel-L Alone or Combined With Hyaluronic Acid (HA) in Subjects With Chronic Low Back Pain. Print details. Share ...

8. withpower.com withpower.com/trial/phase-3-low-back-pain-4-2024-13cd9

Rexlemestrocel-L + HA for Lower Back Pain 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.