VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs.
This is a randomized, sham-controlled, multi-center, double-blind clinical trial with an open label roll-in period of one participant per site in which participants with lumbar discogenic pain associated with DDD will receive one VIA Disc NP treatment to each affected level (up to 2 levels). Participants enrolled after the roll-in stage will be randomized on a 2:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or the sham procedure at 1 or 2 levels. At 12 months, participants in the sham arm with continued symptoms may cross-over, receive VIA Disc NP, and will restart the study visit schedule, completing an additional 12 months of follow-up post-cross-over.
Age 22 to 85 years old
Diagnosis of moderate to severe DDD on MRI, Modified Pfirrmann Grade 3-7
Chronic axial midline low-back pain in the absence of lower extremity motor/sensory/reflex changes 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
Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS
Contraindications to the proposed sedation/anesthetic protocol
Involvement of more than two lumbar discs as evidenced by 3 or more discs with Modified Pfirrmann grade of 3 or greater
Symptomatic vertebral compression fracture
Previous surgical treatment of the lumbar spine
Crossover
VIA Disc NP
Other interventionVIA Disc NP is processed from donated cadaveric disc tissue, lyophilized, and micronized to particles.
Sham
Other interventionA 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. No saline or VIA Disc NP will be injected.
Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from baseline to 12 months.
The primary efficacy endpoint is the proportion of participants who achieve a minimal clinically important difference (MCID), defined as at least a 30% reduction in back pain VAS score from baseline to 12 months, in the VIA Disc NP group compared to that in the sham-control group.
Primary Safety Endpoint - Proportion of participants reporting treatment-related AEs at 12 months.
The primary safety endpoint will be the proportion of participants that experience one or more treatment-related (Investigational Product (IP) or procedure), adverse events (AE) in the VIA Disc NP group compared to the sham-control group at 12 months.
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