RecruitingDegenerative Disc DiseaseDisc DegenerationLumbar Discogenic Pain

Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease

Eligible age

22–85 yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

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About this study

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.

Sponsor: VIVEX Biologics, Inc.

You may qualify if…

✓ 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
✓ ODI score of ≥ 40 to ≤ 80
✓ Positive sustained hip flexion test
✓ Demonstrated intolerance to sitting
✓ Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study

You may not qualify if…

✕ 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
✕ Disc height of less than 4mm for any disc between L1-S1
✕ Symptomatic vertebral compression fracture
✕ Previous surgical treatment of the lumbar spine
✕ History of sacroiliac (SI) joint fusion within the past six months
✕ Received lumbar epidural or intradiscal steroid injection, lumbar facet joint steroid injection, lumbar radiofrequency ablation, provocative or anesthetic discography, SI joint pain injection, injection of methylene blue, dextrose, glucosamine, and chondroitin sulfate, or biacuplasty within 3 months of the Day 0 procedure
✕ Received intraosseous radiofrequency nerve ablation procedure at the same or adjacent level (e.g., Basivertebral nerve ablation or sinuvertebral nerve ablations)