ASCEND: A Randomized, Double Blind, Sham-Controlled, Multi-Center Phase I/II Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 121
- 试验地点
- 10
- 主要终点
- Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from Baseline to 26 weeks.
研究概览
简要总结
VIA Disc NP is an off-the-shelf minimally processed human nucleus pulposus tissue allograft intended to supplement degenerated intervertebral discs.
The study is a randomized, double-blind, sham-controlled, multi-center study in participants with symptomatic lumbar intervertebral disc degeneration (> 6 months) and unresponsive to conservative therapy for at least 3 months. Participants will be randomized on a 1:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or a sham procedure at 1 or 2 levels.
Participants who consent to participate in the study and meet all eligibility criteria during the Screening/Baseline period will return on Day 1 to be randomized to either the VIA Disc NP or sham-control group. At 12-weeks post-treatment, participants allocated to the sham-control group will be given the option to crossover to the VIA Disc NP group if they meet the requirement to crossover.
All participants will be followed through 52-weeks post-treatment at which time they will be asked if they would like to consent to participate in an extended long-term follow-up period. The sham-control group participants who did not crossover at 12-weeks will be exited from the study at this visit. If participants consent to participate in the extended long-term follow-up period, the VIA Disc NP group will be followed through 24-Months and the sham-control group will be followed through 27-months. If the participant declines participation, they will be exited from the study at this visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The following individuals should be blinded in the ASCEND Clinical Trial:
Participants: when randomized into the trial, the patient will consent to be blinded to the type of treatment they will receive
Outcome assessors:
- Clinicians (sub-Is) completing the physical or neurological examination
- Study coordinator administering patient-reported outcomes and collecting other participant data
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22 to 85 years old
- •Diagnosis of early to moderate DDD, Modified Pfirrmann Grade 3-7
- •Chronic axial midline low-back pain with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care
- •Positive hip flexion test as confirmed with the Neurologic Exam indicating positive provocation with sustained hip flexion at the time of screening
- •Demonstrated intolerance to sitting for more than 30 minutes at a time based on self-report or assessed by a qualified healthcare professional at the screening visit
- •Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS at the time of Screening
- •ODI score of ≥ 40 to ≤ 80 at the time of Screening
排除标准
- •Contraindication to MRI for any reason
- •Contraindications to the proposed sedation/anesthetic protocol
- •Symptomatic involvement of more than two lumbar discs
- •Fracture of the lumbar spine, previous lumbar spine surgery or previous treatment of the target disc(s)
- •Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc
- •Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology
- •Clinical suspicion of facet pain as primary pain generator
- •Women who are pregnant or breastfeeding at the time of enrollment and/or plan to become pregnant during the study. Pregnancy is confirmed by:
- •A positive pregnancy test during the screening visit
- •Self-reported pregnancy
- •Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)
研究组 & 干预措施
VIA Disc NP
干预措施: VIA Disc NP (Other)
Sham Arm
干预措施: Sham Injection (Other)
结局指标
主要结局
Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from Baseline to 26 weeks.
时间窗: Baseline to 26 Weeks
A comparison of the proportion of participants who show a minimally clinically important difference (MCID), defined as at least a 30% reduction in back pain VAS score from baseline to 26 weeks (6 months), in the VIA Disc NP group to that in the sham-control group.
Primary Safety Endpoint - Proportion of participants reporting Treatment-related AEs at 12 weeks
时间窗: Baseline to 12 weeks
The proportion of participants that experience one or more treatment-related (including procedure) adverse events in the VIA Disc NP group compared to the sham-control group at 12 weeks (3 months) as determined by the Principal Investigator.
次要结局
未报告次要终点