Abstract No. 46 A Prospective Open-Label Multicenter Study of Nucleus Pulposus Allograft Supplementation in Patients with Lumbar Discogenic Pain: A 35-Patient Pilot Study

This study evaluates the safety and clinical performance of an intradiscal nucleus pulposus (NP) allograft developed to supplement tissue lost in symptomatic degenerative discs by placement with fluoroscopic guidance. Patients demonstrating low back pain of ≥ 6 on the Numeric Rating Scale (NRS) and disability of ≥40 points on the Oswestry Disability Index (ODI) were considered for eligibility. Qualifying inclusion criteria permitted patients with 1- or 2-level symptomatic degenerative lumbar discs refractory to current medical treatments. Baseline initial imaging and 6 months post-injection studies were reviewed by an independent core lab, and the final determination for subject eligibility was proctored by a Medical Monitor external to the study. Patients were provided informed consents after approval by a central institutional review board. Interim results available for 35 patients enrolled were assessed for pain and function improvements at 1 month (n=34); 3 months (n=32); and 6 months (n=30). Significant improvements in pain and function were observed at 1, 3 and 6 months. NRS scores improved from 7.5 to 4.2 to 3.2 to 2.9. ODI scores improved from 51.5 to 27.8 to 22.1 to 20.2. The proportion of subjects at 6-months achieving a clinically significant change of ≥50% improvement in NRS and ≥15-point improvement of ODI was 73% for each metric. Interim data highlights significant clinical improvements in pain and function after injection of an NP intradiscal allograft through 6 months with low evidence of adverse events, with most subjects exceeding the minimal clinically important difference improvements for both pain and function.