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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Mesoblast, Ltd.
Study ID
NCT06325566
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rexlemestrocel-L + HA mixture — DRUG
    Rexlemestrocel-L will be combined in 1:1 by-volume ratio with HA solution and the resulting mixture will be administered as intradiscal injection.
  • Saline — DRUG
    Saline solution injection adjacent to the index disc.

Study Details

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.

Key Dates

Start date
Jul 3, 2024
Status verified
Jan 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score [ Time Frame: Baseline and Month 12 ]

Central Contacts

Locations (39)

FacilityCityStateZIPSite coordinators
Axsendo Clinical Research/Summa Pain CarePhoenixArizona85085
Paul Pannozzo, MD
Paul Pannozzo, MD (PRINCIPAL_INVESTIGATOR)
Pain Institute of Southern ArizonaTucsonArizona85710
Efrain Cubillo, MD
Efrain Cubillo, MD (PRINCIPAL_INVESTIGATOR)
TriWest Research AssociatesChula VistaCalifornia91910
Arthur R Mabaquiao, MD
Arthur Mabaquiao, MD (PRINCIPAL_INVESTIGATOR)
Boomerang Health CareConcordCalifornia94520
Kasra Amirdelfan, MD
Kasra Amirdelfan, MD (PRINCIPAL_INVESTIGATOR)
Memorial Orthopaedic Surgical GroupLong BeachCalifornia90806
Philip S Yuan, MD
Philip S Yuan, MD (PRINCIPAL_INVESTIGATOR)
Newport TherapeuticsNewport BeachCalifornia92660
Rick Paicius, MD
Rick Paicius, MD (PRINCIPAL_INVESTIGATOR)
University of California-Davis Spine CenterSacramentoCalifornia95816
Kee Kim, MD
Kee Kim, MD (PRINCIPAL_INVESTIGATOR)
Innovative Pain Treatment SolutionsSan DiegoCalifornia92111
Krishnan Chakravarthy, MD, PhD
Krishnan Chakravarthy, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of California-San FranciscoSan FranciscoCalifornia94143
Conor O'Neill, MD
Conor O'Neill, MD (PRINCIPAL_INVESTIGATOR)
Source HealthcareSanta MonicaCalifornia90403
Timothy Davis, MD
Timothy Davis, MD (PRINCIPAL_INVESTIGATOR)
Colorado Spine Partners/The Denver Spine and Pain InstituteGreenwoodColorado80111
Gary Ghiselli, MD
Gary Ghiselli, MD (PRINCIPAL_INVESTIGATOR)
Scott Bainbridge, MD (SUB_INVESTIGATOR)
Prime Medical ResearchCoral GablesFlorida33134
Miguel Telleria, MD, MBA
Miguel Telleria, MD, MBA (PRINCIPAL_INVESTIGATOR)
Cantor Spine Center at the Paley Orthopedic & Spine InstituteFort LauderdaleFlorida33306
Anthony Giuffrida, MD
Anthony Giuffrida, MD (PRINCIPAL_INVESTIGATOR)
New Life Medical Research CenterHialeahFlorida33012
Raul Falero, MD
Raul Falero, MD (PRINCIPAL_INVESTIGATOR)
Bold City Clinical ResearchJacksonvilleFlorida32224
Ferdinand Formoso, DO
Ferdinand Formoso, MD (PRINCIPAL_INVESTIGATOR)
OSSO Health, Inc.Miami BeachFlorida33140
Amir Mahajer, DO
Amir Mahajer, DO (PRINCIPAL_INVESTIGATOR)
Interventional Pain InstituteThe VillagesFlorida32162
Brent Compton, MD, DC
Brent Compton, MD, DC (PRINCIPAL_INVESTIGATOR)
Conquest Research LLCWinter ParkFlorida32789
Anand Patel, MD
Anand Patel, MD (PRINCIPAL_INVESTIGATOR)
Emory HealthcareDunwoodyGeorgia30338
Oluseun Olufade, MD
Oluseun Olufade, MD (PRINCIPAL_INVESTIGATOR)
Vista Clinical ResearchNewnanGeorgia30265
Sandeep Vaid, MD
Sandeep Vaid, MD (PRINCIPAL_INVESTIGATOR)
Hawaii Pain & SpineKailuaHawaii96734
Jon Carlson, MD
Jon Carlson, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityKansas66160
Dawood Sayed, MD
Dawood Sayed, MD (PRINCIPAL_INVESTIGATOR)
Iqra ResearchEdgewoodKentucky41017
Zeeshan Tayeb, MD
Zeeshan Tayeb, MD (PRINCIPAL_INVESTIGATOR)
Paradigm Health SystemSlidellLouisiana70458
Thomas Myers, MD
Thomas Myers, MD (PRINCIPAL_INVESTIGATOR)
The Kahan CenterAnnapolisMaryland21401
Brian Kahan, DO
Brian Kahan, DO (PRINCIPAL_INVESTIGATOR)
Reno Tahoe Pain AssociatesRenoNevada89511
Ali Nairizi, MD
Ali Nairizi, MD (PRINCIPAL_INVESTIGATOR)
University of RochesterRochesterNew York14611
Ben LaPlante, DO
Ben LaPlante, DO (PRINCIPAL_INVESTIGATOR)
Eximia EquiHealth Research LLC/Emerge OrthoDurhamNorth Carolina27704
David B Musante, MD
David B Musante, MD (PRINCIPAL_INVESTIGATOR)
AdventHealth HendersonvilleHendersonvilleNorth Carolina28792
William "Jeremy" Beckworth, MD
William "Jeremy" Beckworth, MD (PRINCIPAL_INVESTIGATOR)
Meta Medical Research Institute, LLCDaytonOhio45432
Priyesh Mehta, DO
Priyesh Mehta, DO (PRINCIPAL_INVESTIGATOR)
Clinical Investigations, LLCEdmondOklahoma73034
Douglas P Beall, MD
Douglas P Beall, MD (PRINCIPAL_INVESTIGATOR)
Axsendo Clinical Research/Compass Pain and WellnessPortlandOregon97201
Carl Balog, MD
Carl Balog, MD (PRINCIPAL_INVESTIGATOR)
OSS HealthYorkPennsylvania17402
Michael B Furman, MD
Michael B Furman, MD (PRINCIPAL_INVESTIGATOR)
Rhode Island HospitalProvidenceRhode Island02903
Alexios Carayannopoulos, DO, MPH
Alexios Carayannopoulos, DO, MPH (PRINCIPAL_INVESTIGATOR)
Clinical Trials of South CarolinaCharlestonSouth Carolina29406
Edward M. Tavel Jr., MD
Edward M. Tavel Jr., MD (PRINCIPAL_INVESTIGATOR)
Institute of Precision Pain MedicineCorpus ChristiTexas78414
Mitchell Engle, MD, PhD
Mitchell Engle, MD, PhD (PRINCIPAL_INVESTIGATOR)
Paradigm Research Center/Houston Scoliosis and Spine InstituteHoustonTexas77030
Ra'Kerry Rahman, MD
Ra'Kerry Rahman, MD (PRINCIPAL_INVESTIGATOR)
Axsendo Clinical Research/Texas Institute of Pain and SpinePearlandTexas77584
Lance LaFleur, MD, MBA
Lance LaFleur, MD, MBA (PRINCIPAL_INVESTIGATOR)
VA iSpine PhysiciansRichmondVirginia23238
Michael J DePalma, MD
Michael J DePalma, MD (PRINCIPAL_INVESTIGATOR)

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