Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Degenerative Disc Disease

In brief

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 participants with chronic low back pain (\> 6 months) associated with moderate radiographic degenerative changes of a disc.

Key facts

Study ID

NCT02412735

Run by

Mesoblast, Ltd.

People needed

404

Starts

2015-03-06

Expected to finish

2021-06-15

Last updated by the study team

2022-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female participants 18 years of age and older
• If female of childbearing potential, participant 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 participant 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 chronic low back pain (CLBP) associated with moderate radiographic degeneration at a lumbar disc is defined as the following (participant must meet all of the listed conditions):
• Chronic low back pain for at least 6 months
• 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)
• 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. non-steroidal anti-inflammatory drug (NSAID) and/or opioid medication).
• 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 magnetic resonance imaging (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 visual analogue scale (VAS) (average pain over 24 hours)
• f. Leg pain ≤20mm in both legs on a 100mm VAS scale
• g. Oswestry disability index (ODI) score of at least 30 and no more than 90 on a 100 point scale.

You may not qualify if…

• Female participants who are pregnant or nursing, or women planning to become pregnant in the first 24 months post-treatment
• Extreme obesity, as defined by National Institutes of Health (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 participant.
• 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:
• Contrast medium (discography or other diagnostic injection)
• NSAIDs
• Nerve-blocking anesthetics (e.g., lidocaine, bupivacaine)
• Antibiotics
• 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 immunosuppressants
• 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.
• Participants 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

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Tennessee Valley Pain Consultants — Huntsville, Alabama, United States
• Arizona Pain Specialists — Scottsdale, Arizona, United States
• Physicians Research Group — Tempe, Arizona, United States
• TriWest Research Associates, LLC — El Cajon, California, United States
• Memorial Orthopaedics Surgical Group — Long Beach, California, United States
• Newport Beach Headache and Pain — Newport Beach, California, United States
• Institute for Regenerative Medicine and Clinical Research — Pasadena, California, United States
• UC Davis Spine Center — Sacramento, California, United States
• Orthopedic Pain Specialists — Santa Monica, California, United States
• The Spine Institute — Santa Monica, California, United States
• Summit Pain Alliance — Santa Rosa, California, United States
• Integrated Pain Management — Walnut Creek, California, United States
• Denver Back Pain Specialists, LLC — Greenwood Village, Colorado, United States
• George Washington University Medical Center — Washington D.C., District of Columbia, United States
• Coastal Clinical Research Specialists — Fernandina Beach, Florida, United States
• Shrock Orthopedic Research, LLC — Fort Lauderdale, Florida, United States
• Holy Cross Orthopedics Institute — Oakland Park, Florida, United States
• Emory Orthopaedics & Spine Center — Atlanta, Georgia, United States
• Georgia Institute for Clinical Research, LLC — Marietta, Georgia, United States
• Injury Care Medical Center — Boise, Idaho, United States
• Millennium Pain Center — Bloomington, Illinois, United States
• Otrimed Clinical Research — Edgewood, Kentucky, United States
• Orthopedic Specialists of Louisiana — Shreveport, Louisiana, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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