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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
496
VIA Disc NP is processed from donated cadaveric disc tissue, lyophilized, and micronized to particles.
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. No saline or VIA Disc NP will be injected.
Interventional Pain Management Napa Valley Orthopedic Medical Group
Napa, California, United States
RECRUITINGSource Healthcare
Santa Monica, California, United States
RECRUITINGPremier Spine and Pain Institute
Thornton, Colorado, United States
RECRUITINGThe Orthopaedic Institute
Gainesville, Florida, United States
RECRUITINGGeorgia Pain Management
Woodstock, Georgia, United States
RECRUITINGHenry Community Health
New Castle, Indiana, United States
RECRUITINGOchsner Clinic Foundation
New Orleans, Louisiana, United States
RECRUITINGSpine Institute of Louisiana
Shreveport, Louisiana, United States
RECRUITINGParadigm Health System
Slidell, Louisiana, United States
RECRUITINGNevada Advanced Pain Specialists
Reno, Nevada, United States
RECRUITING...and 7 more locations
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.
Time frame: Baseline to 12 Months
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.
Time frame: Baseline to 12 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.