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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 (MSB-DR003)

This study is currently recruiting participants.
Verified November 2017 by Mesoblast, Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02412735
First Posted: April 9, 2015
Last Update Posted: November 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Mesoblast, Ltd.
  Purpose
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 Intervention Phase
Degenerative Disc Disease Drug: rexlemestrocel-L Drug: rexlemestrocel-L + HA Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Resource links provided by NLM:


Further study details as provided by Mesoblast, Ltd.:

Primary Outcome Measures:
  • 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:
  • 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

  • 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

  • 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

  • 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

  • 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.


Estimated Enrollment: 360
Study Start Date: March 2015
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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


Contacts
Contact: David Nunez 512-826-8897 david.nunez@mesoblast.com

  Show 48 Study Locations
Sponsors and Collaborators
Mesoblast, Ltd.
Quintiles, Inc.
Investigators
Study Director: Roger Brown Mesoblast, Ltd.
  More Information

Responsible Party: Mesoblast, Ltd.
ClinicalTrials.gov Identifier: NCT02412735     History of Changes
Other Study ID Numbers: MSB-DR003
First Submitted: March 25, 2015
First Posted: April 9, 2015
Last Update Posted: November 29, 2017
Last Verified: November 2017

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