Clinical trial NCT06325566: Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Degenerative Disc Disease
Lead sponsor: Mesoblast, Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Month 24
Secondary outcomes:
measure: Percentage of 30% VAS Pain Responders at 12 Months Post-treatment
timeFrame: Month 12
measure: Mean Change From Baseline in Quality of Life Measured by Euroqol-5D (EQ-5D) Index Score at 12 Months Post-treatment
timeFrame: Baseline and Month 12
measure: Percentage of Minimal Pain Responders at 12 Months Post-treatment
timeFrame: Month 12
measure: Mean Change From Baseline in Function as Measured by Oswestry Disability Index (ODI) Questionnaire Score at 12 Months Post-treatment
timeFrame: Baseline and Month 12
measure: Percentage of Participants With 30% VAS and 10-point ODI Treatment Success at 12 Months Post-treatment
timeFrame: Month 12
measure: Percentage of Participants Who Ceased Opioid Usage at 24 Months Post-treatment
timeFrame: Month 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Ortho, Spine and Sports, PC
state: Alabama
city: Chula Vista
country: United States
facility: TriWest Research Associates
state: California
city: Concord
country: United States
facility: Boomerang Health Care
state: California
city: Long Beach
country: United States
facility: Memorial Orthopaedic Surgical Group
state: California
city: Sacramento
country: United States
facility: UC Davis Spine Center
state: California
city: San Diego
country: United States
facility: Innovative Pain Treatment Solutions
state: California
city: Santa Monica
country: United States
facility: Source Healthcare
state: California
city: Greenwood
country: United States
facility: Colorado Spine Partners/The Denver Spine and Pain Institute
state: Colorado
city: Jacksonville
country: United States
facility: Bold City Clinical Research
state: Florida
city: Riverview
country: United States
facility: West Florida Surgical Suites
state: Florida
city: Winter Park
country: United States
facility: Conquest Research LLC
state: Florida
city: Dunwoody
country: United States
facility: Emory Ambulatory Surgery Center
state: Georgia
city: Boise
country: United States
facility: The Pain Centre, Inc.
state: Idaho
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Edgewood
country: United States
facility: Iqra Research
state: Kentucky
city: Reno
country: United States
facility: Reno Tahoe Pain Associates, Suite 300
state: Nevada
city: Durham
country: United States
facility: Eximia EquiHealth Research LLC
state: North Carolina
city: Hendersonville
country: United States
facility: AdventHealth Hendersonville
state: North Carolina
city: Dayton
country: United States
facility: Meta Medical Research Institute, LLC
state: Ohio
city: Edmond
country: United States
facility: Clinical Investigations, LLC
state: Oklahoma
city: York
country: United States
facility: OSS Health
state: Pennsylvania
city: Richmond
country: United States
facility: VA iSpine Physicians
state: Virginia
Study officials:
affiliation: Mesoblast, Ltd.
name: Roger D Brown
role: STUDY_DIRECTOR
References: