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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02412735




Registration number
NCT02412735
Ethics application status
Date submitted
25/03/2015
Date registered
9/04/2015

Titles & IDs
Public title
Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain
Scientific 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
Secondary ID [1] 0 0
MSB-DR003
Universal Trial Number (UTN)
Trial acronym
MSB-DR003
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative Disc Disease 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rexlemestrocel-L
Treatment: Drugs - Rexlemestrocel-L + HA Mixture
Treatment: Drugs - Placebo

Experimental: Rexlemestrocel-L - Participants received 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 saline on Day 0 (Visit 2).

Experimental: Rexlemestrocel-L + HA - Participants received 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 (Visit 2).

Placebo comparator: Placebo - Participants received saline solution as matching-placebo on Day 0 (Visit 2).


Treatment: Drugs: Rexlemestrocel-L
Rexlemestrocel-L injection

Treatment: Drugs: Rexlemestrocel-L + HA Mixture
Rexlemestrocel-L was combined in 1:1 by-volume ratio with HA solution and the resulting mixture was injected

Treatment: Drugs: Placebo
Saline control solution
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Treatment Success: Bayesian Estimated Response Rate
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Effectiveness Based on Pain Responders: Bayesian Estimated Response Rate
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Effectiveness Based on Functional Responders: Bayesian Estimated Response Rate
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Effectiveness Based on Treatment Success at 24 Months: Bayesian Estimated Response Rate
Timepoint [3] 0 0
Month 24
Secondary outcome [4] 0 0
Effectiveness Based on Minimal Pain Responders at 24 Months: Bayesian Estimated Response Rate
Timepoint [4] 0 0
Month 24
Secondary outcome [5] 0 0
Effectiveness Based on Time to First Intervention Over 24 Months
Timepoint [5] 0 0
Up to Month 24
Secondary outcome [6] 0 0
Effectiveness Based on Minimal Disability Responders at 24 Months: Bayesian Estimated Response Rate
Timepoint [6] 0 0
Month 24

Eligibility
Key inclusion criteria
* 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):

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. non-steroidal anti-inflammatory drug (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 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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:

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 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
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/06/2021
Sample size
Target
Accrual to date
Final
404
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Center - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
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Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
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Minnesota
Country [13] 0 0
United States of America
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Nevada
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New Jersey
Country [15] 0 0
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New York
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North Carolina
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Ohio
Country [18] 0 0
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Oklahoma
Country [19] 0 0
United States of America
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Pennsylvania
Country [20] 0 0
United States of America
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Rhode Island
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mesoblast, Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Quintiles, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Roger Brown
Address 0 0
Mesoblast, Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02412735