1. 2024;27;E865-E871Nucleus Pulposus Allograft Supplementation in Patients with Lumbar Discogenic Pain: Initial 6-month Outcomes from a Prospective Clinical Pilot Study
   Pilot Study
   Douglas P. Beall, MD, Timothy T. Davis, MD, Kasra Amirdelfan, MD, Ramana K. Naidu, MD, Michael J. DePalma, MD, Shrif Costandi, MD, Jacob W. Fleming, MD, Edward S. Yoon, MD, Timothy Ganey, PhD, Jon E. Block, PhD, and Nagy Mekhail, MD, PhD.

BACKGROUND: Preventing disc degeneration remains a clinical challenge; patients experiencing chronic lumbar discogenic pain have limited treatment options. Minimally invasive intradiscal procedures such as allogeneic nucleus pulposus (NP) injection have the potential to fill the treatment gap between failed conservative care and spine surgery.

OBJECTIVES: Our study sought to evaluate the magnitude and durability of improvement in back function in patients with chronic lumbar discogenic pain followed for 6 months after a single intradiscal injection of minimally manipulated, off-the-shelf processed NP allograft (VIA Disc NP®, VIVEX Biologics, Inc.) at up to 2 vertebral levels.

STUDY DESIGN: Single-arm, prospective, multicenter, pilot study.

SETTING: Academic and private practice outpatient clinics.

METHODS: A total of 29 patients with symptomatic lumbar discogenic pain refractory to conservative care who had a back function score of  40-80 points on the Oswestry Disability Index (ODI), >= 6 on an 11-point back pain Numeric Rating Scale (NRS-11) and corresponding imaging evidence of disc degeneration were enrolled. A single dose, intradiscal injection of approximately 100 mg of NP allograft mixed with sterile saline was administered to the affected level or levels.

RESULTS: The average ODI and NRS-11 improvements between baseline and 6-months postprocedure were 54.8% (95% CI, 41.3-68.3) and 52.9% (95% CI, 34.7-71.1) respectively (P < 0.001). A minimal clinically important difference of >= 30% improvement over baseline was achieved in 79% (22 of 28) and 68% (19 of 28) of patients for ODI and NRS-11, respectively. At 6-months postprocedure, 64% (18 of 28) of patients had an NRS-11 score >= 3.

LIMITATIONS: This pilot study did not employ a concurrent control group and the clinical follow-up was limited to 6 months.

CONCLUSIONS: These pilot findings demonstrate the feasibility of treating patients with symptomatic lumbar disc degeneration with a single intradiscal injection of allogeneic NP to provide significant and durable improvements in back function and pain.

KEY WORDS: Disc degeneration, nucleus pulposus allograft, low back pain, tissue supplementation, Oswestry Disability Index, discogenic