156 - Nucleus Pulposus Supplementation for Intervertebral Disc Degeneration: Evaluation of Pain and Functional Outcomes from Two Clinical Studies

Purpose: Intervertebral disc (IVDs) consists of the annulus fibrosus (AF), nucleus pulposus (NP), and a cartilaginous endplates. Degeneration of the IVD is characterized by a loss of hydration of the NP, a depletion of proteoglycans, and a decrease in disc height that can often lead to pain.¹ Disc degeneration is often associated with chronic lower back pain (cLBP)² and patients experiencing chronic lumbar discogenic pain currently have limited non-surgical treatment options. Herein, we present safety data as well as pain and functional outcomes from two multi-center, prospective clinical studies following intradiscal supplementation of nucleus pulposus allograft for patients with symptomatic discogenic low back pain.

Materials and Methods: Two prospective, multi-center, single arm pilot studies were conducted across 11 participating institutions in the United States. Both studies had the same inclusion criteria with the following exceptions One study included subjects ≥65 years (up to three treated levels), the other ≥18 years (up to two levels). Subjects were given a single treatment of a human nucleus pulposus tissue allograft (VIA Disc NP®, Vivex Biologics, Miami FL, USA) at up to three levels in the lumbar spine. For both studies, subject reported outcomes including pain via the numeric rating scale (NRS) and function via the Oswestry Disability Index (ODI) were collected at specified timepoints through 6 months. Safety was assessed by collection of all adverse events.

Results: A total of 49 subjects were enrolled across both studies (n = 28 male, n = 21 female). 16 subjects (33%) received NP allograft at one-level, 27 subjects (55%) received NP two-levels, and 6 subjects (12%) were treated at 3 levels. Mean pain at baseline was 6.89 ± 1.46 and mean ODI was 49.74 ± 15.12. At 1-month, significant improvement in subject reported pain (NRS = 3.61 ± 2.62, p < 0.001) and function (ODI = 28.56 ± 18.28, p < 0.001) was observed. These improvements continued throughout follow-up (Figure 1). Of 24 reported adverse events, 4 (16.7%) were reported to be possibly related to NP allograft, and all were classified as mild.

Conclusion: Data from these clinical studies provide additional evidence that nucleus pulposus supplementation with NP allograft is safe and is associated with clinically significant functional improvement and pain palliation. Minimally invasive delivery of NP allograft may be able to bridge the current treatment gap for patients experiencing chronic lumbar discogenic pain. Larger, randomized, controlled trials are ongoing to further establish the safety and clinical efficacy of NP allograft.