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Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Subjects With Chronic Low Back Pain (MSB-DR003)

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ClinicalTrials.gov Identifier: NCT02412735
Recruitment Status : Active, not recruiting
First Posted : April 9, 2015
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Mesoblast, Ltd.

Brief Summary:
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in subjects with chronic low back pain (> 6 months) associated with moderate radiographic degenerative changes of a disc

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Drug: rexlemestrocel-L Drug: rexlemestrocel-L + HA Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Alone or Combined With Hyaluronic Acid (HA) in Subjects With Chronic Low Back Pain
Actual Study Start Date : March 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: rexlemestrocel-L
rexlemestrocel-L alone": 2.0 mL formulation of approximately 6 million rexlemestrocel-L cells
Drug: rexlemestrocel-L
rexlemestrocel-L alone": 2.0 mL formulation of approximately 6 million rexlemestrocel-L cells - Intervention will be injected into the painful intervertebral disc

Experimental: rexlemestrocel-L + HA
rexlemestrocel-L + HA": 2.0mL 6 million rexlemestrocel-L cells
Drug: rexlemestrocel-L + HA
rexlemestrocel-L + HA": 2.0mL 6 million rexlemestrocel-L cells with 1% HA - Intervention will be injected into the painful intervertebral disc

Placebo Comparator: Placebo
saline control: 2.0 mL saline solution
Drug: Placebo
saline control: 2.0 mL saline solution




Primary Outcome Measures :
  1. Treatment Success (composite responder analysis of low back pain Visual Analogue Scale (VAS) score, Oswestry Disability Index (ODI) score and no post-treatment interventions) [ Time Frame: 24 Months ]
    • To determine Overall Treatment Success of rexlemestrocel-L alone or rexlemestrocel-L+HA through 24 months based on a composite responder analysis


Secondary Outcome Measures :
  1. Effectiveness (Pain Responder analysis) [ Time Frame: 24 months ]
    • To evaluate the effectiveness of rexlemestrocel-L alone or rexlemestrocel-L+HA in reducing chronic low back pain by performing a Pain Responder analysis through 24 months post-treatment

  2. Effectiveness (Functional Responder analysis) [ Time Frame: 24 months ]
    • To evaluate the effectiveness of rexlemestrocel-L alone or rexlemestrocel-L+HA in improving function by performing a Functional Responder analysis through 24 months post-treatment

  3. Effectiveness (Treatment Success at 24 months) [ Time Frame: 24 months ]
    To determine the Treatment Success at 24 months of rexlemestrocel-L alone or rexlemestrocel-L+HA based upon a composite responder analysis

  4. Effectiveness (Minimal Pain Responder at 24 months) [ Time Frame: 24 months ]
    Minimal Pain Responder at 24 Months: Measured as subjects meeting low back pain VAS score threshold

  5. Effectiveness (Time to first intervention) [ Time Frame: 24 months ]
    To evaluate the effectiveness of rexlemestrocel-L alone or rexlemestrocel-L+HA on reducing the time to additional interventions at the treated level over 24 months post-treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects 18 years of age and older
  • If female of childbearing potential, subject is non-pregnant, non-nursing, and agrees to use highly effective methods of contraception for a minimum of 24 months post-treatment
  • Signed informed consent and country-appropriate privacy forms indicating subject is willing to undergo treatment and willing to be available for each examination scheduled over the study duration
  • Have documented diagnosis of moderate radiographic degeneration of an intervertebral disc from L1 to S1, with a disc suspected of causing CLBP Chronic low back pain associated with moderate radiographic degeneration at a lumbar disc is defined as the following (subject must meet all of the listed conditions):

    1. Chronic low back pain for at least 6 months
    2. Have failed 6 months of conservative back pain care. (Conservative treatment regimens may include any or all of the following: initial rest, medications [e.g., anti-inflammatory, analgesics, narcotics/opioids, muscle relaxants], massage, acupuncture, chiropractic manipulations, activity modification, home-directed lumbar exercise program, and non-invasive pain control treatments or procedures)
    3. Have at a minimum undergone supervised physical therapy, such as daily walking routines, therapeutic exercises, and back education programs specifically for the treatment of low back pain AND taken a pain medication for back pain (e.g. NSAID and/or opioid medication).
    4. Change from normal disc morphology of the index disc as defined by radiographic evaluation by the core imaging evaluation provider. Radiographs must show all of the following:
  • A modified Pfirrmann score of 3, 4, 5 or 6 on MRI at the index disc
  • Modic Grade II changes or less on MRI at the index disc
  • With or without contained disc protrusion at the index disc on MRI

    e. Low back pain of at least 40mm and not more than 90mm of 100mm on low back pain VAS (average pain over 24 hours)

    f. Leg pain ≤20mm in both legs on a 100mm VAS scale

    g. ODI score of at least 30 and no more than 90 on a 100 point scale.

Exclusion Criteria:

  • Female subjects who are pregnant or nursing, or women planning to become pregnant in the first 24 months post-treatment
  • Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI > 40)
  • Have undergone a surgical procedure (e.g. discectomy, intradiscal electrothermal therapy, intradiscal radiofrequency, artificial disc replacement, interbody fusion) on the disc at the index or adjacent level
  • Osteoporosis, as defined by dual-energy X-ray absorptiometry (DEXA) scan. A DEXA T-score of ≤ -2.5 will exclude the subject.
  • Any lumbar intradiscal injection, including steroids, into the index or adjacent discs prior to treatment injection, with the exception of the following injections performed at least 2 weeks prior to study treatment:

    1. Contrast medium (discography or other diagnostic injection)
    2. NSAIDs
    3. Nerve-blocking anesthetics (e.g., lidocaine, bupivacaine)
    4. Antibiotics
    5. Saline
  • Have undergone a procedure affecting the structure/biomechanics of the index disc level (e.g., posterolateral fusion)
  • Active malignancy or tumor as source of symptoms or history of malignancy within the 5 years prior to enrolment on study
  • 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
  • An average baseline morphine equivalent dose (MED) of >75mg/day as determined by e-diary entries during the screening period
  • Taking systemic immunosuppresants
  • A medical condition, serious intercurrent illness, or extenuating circumstance that would preclude participation in the study or potentially decrease survival or interfere with ambulation or rehabilitation.
  • Subjects involved in spinal litigation, including workman's compensation, unless litigation is complete
  • Are transient or has a severe alcohol or substance abuse problem
  • Clinically significant nerve pain (e.g., chronic radiculopathy or neuropathy)
  • Clinically significant sacroiliac joint pain
  • Compressive pathology due to stenosis or disc protrusion on MRI with associated clinical symptoms defined as leg pain VAS>20mm out of 100mm or neurologic deficit on neurologic exam
  • Disc extrusion with a maximum dimension greater or equal to twice the posterior height of the disc, or disc sequestration in the lumbar spine on MRI as determined by radiographic core lab
  • Modified Pfirrmann score of 7 or 8 at any lumbar level (L1-S1) on MRI evaluation as determined by radiographic core lab
  • Symptomatic involvement of more than one lumbar disc
  • Symptomatic central vertebral canal stenosis as defined by neurogenic claudication
  • Spondylolisthesis or retrolisthesis Grade 2 and above or Spondylolysis at the index or adjacent level(s)
  • Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc
  • Spinal deformity defined as lumbar scoliosis with a Cobb angle of the lumbar spine greater than 15 degrees
  • Any fracture of the spine at the index or adjacent levels that has not healed, or clinically compromised vertebral bodies at the index level due to current or past trauma
  • Facet pain at the index level or adjacent segments as determined by a diagnostic medial branch block (a facet block injection is not acceptable for making this determination) to rule out facet joint involvement.
  • Full thickness annular tears in the index level as determined by free flowing contrast media through the annulus fibrosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02412735


  Hide Study Locations
Locations
United States, Alabama
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
Tennessee Valley Pain Consultants
Huntsville, Alabama, United States, 35801
United States, Arizona
Arizona Pain Specialists
Scottsdale, Arizona, United States, 85258
Physicians Research Group
Tempe, Arizona, United States, 85284-2604
United States, California
TriWest Research Associates, LLC
El Cajon, California, United States, 92020-4124
Memorial Orthopaedics Surgical Group
Long Beach, California, United States, 90806
Newport Beach Headache and Pain
Newport Beach, California, United States, 92660
Institute for Regenerative Medicine and Clinical Research
Pasadena, California, United States, 91105
UC Davis Spine Center
Sacramento, California, United States, 95816
Orthopedic Pain Specialists
Santa Monica, California, United States, 90403
The Spine Institute
Santa Monica, California, United States, 90403
Summit Pain Alliance
Santa Rosa, California, United States, 95401
Integrated Pain Management
Walnut Creek, California, United States, 94598
United States, Colorado
Denver Back Pain Specialists, LLC
Greenwood Village, Colorado, United States, 80111
United States, District of Columbia
George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Florida
Coastal Clinical Research Specialists
Fernandina Beach, Florida, United States, 32034
Shrock Orthopedic Research, LLC
Fort Lauderdale, Florida, United States, 33316
Holy Cross Orthopedics Institute
Oakland Park, Florida, United States, 33334
United States, Georgia
Emory Orthopaedics & Spine Center
Atlanta, Georgia, United States, 30329
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, United States, 30060
United States, Idaho
Injury Care Medical Center
Boise, Idaho, United States, 83713
United States, Illinois
Millennium Pain Center
Bloomington, Illinois, United States, 61701
United States, Kentucky
Otrimed Clinical Research
Edgewood, Kentucky, United States, 41017
United States, Louisiana
Orthopedic Specialists of Louisiana
Shreveport, Louisiana, United States, 71103
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
MAPS Applied Research Center
Shakopee, Minnesota, United States, 55379
United States, Nevada
Innovative Pain Care Center
Las Vegas, Nevada, United States, 89129
United States, New Jersey
University Clinical Research
Somerset, New Jersey, United States, 08873
United States, New York
Ainsworth Institute of Pain Management
New York, New York, United States, 10022
Rochester Regional Health
Rochester, New York, United States, 14626
United States, North Carolina
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States, 28204
On Site Clinical Solutions, LLC
Morrisville, North Carolina, United States, 28117
The Center for Clinical Research/ Carolinas Pain Institute
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44106
DOC Clinical Research
Dayton, Ohio, United States, 45432
United States, Oklahoma
Clinical Investigations, LLC
Edmond, Oklahoma, United States, 73013
United States, Pennsylvania
Orthopaedic and Spine Specialists
York, Pennsylvania, United States, 17402
United States, Rhode Island
RI Hospital-Comprehensive Spine Center
Providence, Rhode Island, United States, 02903
United States, South Carolina
Clinical Trials of South Carolina
Charleston, South Carolina, United States, 29406
Greenville Pharmaceutical Research, Inc.
Charleston, South Carolina, United States, 29406
United States, Texas
Texas Back Institute
Plano, Texas, United States, 75093
Spine Team Texas
Southlake, Texas, United States, 76092
Precision Spine Care
Tyler, Texas, United States, 75701
United States, Utah
Ericksen Research & Development, LLC
Bountiful, Utah, United States, 84010
the SMART Clinic
Draper, Utah, United States, 84020
Hope Research Institute
Saint George, Utah, United States, 84790
United States, Virginia
Virginia iSpine Physicians, PC
Richmond, Virginia, United States, 23235
Australia, Victoria
Monash Medical Center
Clayton, Victoria, Australia, 3168
Sponsors and Collaborators
Mesoblast, Ltd.
Quintiles, Inc.
Investigators
Study Director: Roger Brown Mesoblast, Ltd.

Responsible Party: Mesoblast, Ltd.
ClinicalTrials.gov Identifier: NCT02412735     History of Changes
Other Study ID Numbers: MSB-DR003
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Keywords provided by Mesoblast, Ltd.:
Mesoblast
Chronic Lumbar Back Pain
Low back pain
Back pain
Degenerative Disc Disease
Injection of Degenerated Lumbar Disc
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Spinal Diseases
Stem Cells
Adult Stem Cells
Allogeneic Mesenchymal Precursor cells (MPCs)
Hyaluronic Acid
Pharmaceutical Solutions
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Protective Agents
rexlemestrocel-L
Viscosupplements

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Intervertebral Disc Degeneration
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents