Degenerative Disc Disease, Disc Degeneration, Lumbar Discogenic Pain
Conditions
Keywords
Degenerative Disc Disease, Lumbar Discogenic Pain
Brief summary
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.
Interventions
OTHERSham Injection
Participants will receive the sham procedure at 1 or 2 levels. The procedure will be identical to the investigational procedure with the following exception: A 20G spinal needle will be carefully inserted through the skin and muscle of the back but WILL NOT penetrate the annulus fibrosus of the intervertebral disc.
OTHERVIA Disc NP
Participants will receive a single dose, intradiscal injection of 100 mg of VIA Disc NP mixed with sterile saline according to product Instructions for Use (IFU) and administered to the affected level(s), L1-S1 (1 or 2 levels).
Sponsors
VIVEX Biologics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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
Intervention model description
At the 12-week follow-up, all participants will remain blinded and will be given the option to be considered for crossover. Only participants allocated to the needle sham control group will be given the option to crossover into the VIA Disc NP group at the 12-week visit if they meet the following requirement: The participant has not experienced at least a 30% reduction in pain severity as determined by their 12-week VAS score Sham participants who crossover into the VIA Disc NP group will receive an injection of VIA Disc NP and continue in the study.
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Age 22 to 85 years old 2. Diagnosis of early to moderate DDD, Modified Pfirrmann Grade 3-7 3. 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 4. Positive hip flexion test as confirmed with the Neurologic Exam indicating positive provocation with sustained hip flexion at the time of screening 5. 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 6. Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS at the time of Screening 7. ODI score of ≥ 40 to ≤ 80 at the time of Screening Key
Exclusion criteria
1. Contraindication to MRI for any reason 2. Contraindications to the proposed sedation/anesthetic protocol 3. Symptomatic involvement of more than two lumbar discs 4. Fracture of the lumbar spine, previous lumbar spine surgery or previous treatment of the target disc(s) 5. Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc 6. Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology 7. Clinical suspicion of facet pain as primary pain generator 8. 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 9. Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from Baseline to 26 weeks. | 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 | 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. |
Countries
Australia
Outcome results
None listed