Special Poster Session 51st International Society for the Study of the Lumbar Spine Annual Meeting 2025

Intradiscal Augmentation with Nucleus Pulposus Allograft for Symptomatic Discogenic Low Back Pain: A Prospective, Multi-center, Pilot Study. (115720)

Douglas P Beall 1 , Timothy T Davis 2 , Kasra Amirdelfan 3 , Ramana K Naidu 4 , Michael J DePalma 5 , Shrif Costandi 6 , Jacob W Fleming 7 , Nagy Mekhail 6 , Edward S Yoon 8 , Matthew C Shonnard 1
  1. Comprehensive Specialty Care, Edmond, OK, United States
  2. Source Healthcare, Santa Monica, CA, USA
  3. Boomerang Healthcare, Inc.,, Walnut Creek, CA, USA
  4. MarinHealth Spine Institute, Larkspur, CA, USA
  5. Virginia iSpine Physicians, Richmond, VA, USA
  6. Cleveland Clinic, Cleveland, OH, USA
  7. Radiology Associates of North Texas, P.A., Fort Worth, TX, USA
  8. Hospital for Special Surgery, New York, NY, USA

INTRODUCTION

Intervertebral discs (IVDs) consist of the annulus fibrosus (AF), nucleus
pulposus (NP), and a cartilaginous endplate.1 Degeneration of the IVDs is characterized
by a loss of hydration of the NP, a loss of proteoglycans, and a decrease in disc height
that can often lead to pain.2 Disc degeneration is associated with chronic lower back
pain (cLBP)3; and patients experiencing chronic lumbar discogenic pain currently have
limited treatment options. The purpose of this prospective, multi-center, pilot study was
to evaluate the safety and clinical effectiveness of intradiscal nucleus pulposus allograft
supplementation in patients with symptomatic discogenic low back pain.

METHODS

A prospective, multi-center single arm study was conducted at six
participating institutions in the United States. Following IRB approval, consented
patients meeting inclusion and exclusion criteria received a single treatment of a human
nucleus pulposus tissue allograft (VIA Disc NP, Vivex Biologics, Miami FL, USA) at one
or two levels in the lumbar spine. Patient reported outcomes including pain via the
numeric rating scale (NRS) and patient reported function via the Oswestry Disability
Index (ODI) were collected at specified timepoints through 1-year. Safety of the NP was
assessed by collection of all adverse events.

RESULTS

28 patients were enrolled in this study (n = 16 male, n = 12 female). Mean age
was 43.9 ± 13.11 years (range 19 – 70). 12 patients (43%) received NP at one-level and
16 patients (57%) received NP at two-levels. Mean pain at baseline was 7.07 ± 1.59
and mean ODI was 53.33 ± 14.53. At 1-month, significant improvement in patient
reported pain (NRS = 3.86 ± 2.73, p < 0.001) and function (ODI = 28.21± 19.55, p<
0.001) was observed. These improvements continued throughout the 1-year follow-up
(Figure 1). Of 17 reported adverse events, 3 AEs were reported to be possibly related to
NP allograft (17.6%). One serious adverse event occurred that was unrelated to NP
allograft.

67376a0ed1264-ISSLS+Figure+1.jpgCONCLUSION

This pilot study provides additional evidence that nucleus supplementation
with NP allograft is safe and is associated with clinically significant functional
improvement and pain palliation. Minimally invasive delivery of NP 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.

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  2. 2. Chen S, Fu P, Wu H, Pei M. Meniscus, articular cartilage and nucleus pulposus: a comparative review of cartilage-like tissues in anatomy, development and function. Cell Tissue Res. 2017;370(1):53–70.
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