NCT02412735已完成3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 48
- 主要终点
- Overall Treatment Success: Bayesian Estimated Response Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
- •Nerve-blocking anesthetics (e.g., lidocaine, bupivacaine)
- •Antibiotics
- •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.
研究组 & 干预措施
Rexlemestrocel-L
Experimental
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).
干预措施: Rexlemestrocel-L (Drug)
Rexlemestrocel-L + HA
Experimental
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).
干预措施: Rexlemestrocel-L + HA Mixture (Drug)
Placebo
Placebo Comparator
Participants received saline solution as matching-placebo on Day 0 (Visit 2).
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Treatment Success: Bayesian Estimated Response Rate
时间窗: Up to 24 months
Overall treatment success was determined based on number of responders who had composite response at both months 12 and 24 evaluated per specified criteria. A treatment responder with treatment success was defined as a participant who met the 3 criteria of a composite responder analysis as: 50% or greater reduction in the lower-back pain visual analogue scale (VAS) score; 15-point or greater reduction in the Oswestry Disability Index (ODI) score; and lack of post-treatment interventions at the treated level as of the study visit (Visits 6 \[12 months post-treatment\] and 8 \[24 months post-treatment\]). The average response rate (proportion of participants with response presented as Bayesian estimate\[BE\]) was based upon the average of multiple Bayesian simulations.
次要结局
- Effectiveness Based on Functional Responders: Bayesian Estimated Response Rate(Up to 24 months)
- Effectiveness Based on Treatment Success at 24 Months: Bayesian Estimated Response Rate(Month 24)
- Effectiveness Based on Minimal Pain Responders at 24 Months: Bayesian Estimated Response Rate(Month 24)
- Effectiveness Based on Pain Responders: Bayesian Estimated Response Rate(Up to 24 months)
- Effectiveness Based on Minimal Disability Responders at 24 Months: Bayesian Estimated Response Rate(Month 24)
- Effectiveness Based on Time to First Intervention Over 24 Months(Up to Month 24)
研究者
研究点 (48)
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