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A single intradiscal injection of allogeneic NP reduced chronic lumbar discogenic pain and improved function at 12 months, according to a recent study.

A single intradiscal injection of allogeneic nucleus pulposus (NP) significantly reduced chronic lumbar discogenic pain and improved function at 12 months, according to a recent prospective study published in BMC Musculoskeletal Disorders. Two-thirds of patients experienced clinically meaningful pain reduction, and half exhibited substantial improvement in disability scores.

“Degeneration of the intervertebral disc is a significant source of chronic axial low back pain,” noted study author Edward S. Yoon, MD, Hospital for Special Surgery, and colleagues. “Direct supplementation of degenerated nucleus pulposis (NP) tissue with intradiscally delivered allogeneic NP represents an opportunity to bridge the treatment gap between failed conservative care and spine surgery for patients with lumbar discogenic pain.”

The research team’s primary objective was to quantify the extent of back pain relief and functional improvement at 12 months following a single intradiscal injection of a commercial NP allograft, administered to one or two MRI-confirmed degenerated lumbar levels, in patients with chronic discogenic pain.

Study Design & Methods

According to the authors, the multicenter, single-arm trial enrolled 28 adults (≥18 years old; BMI < 35 kg/m²) with moderate lumbar disc degeneration (modified Pfirrmann grade 3–7) at one or two levels and chronic (>6 months) pain unresponsive to standard non-surgical treatments. Each participant received a single fluoroscopically guided injection of 100 mg VIA Disc NP—a human allogeneic NP morselized to ≤106 µm and reconstituted in saline—under conscious sedation.

Patient-reported pain and function were assessed using the Numerical Rating Scale (NRS) and Oswestry Disability Index (ODI) at baseline and at 4 weeks, 3, 6, and 12 months post-procedure. Analyses employed repeated measures analysis of variance, paired t‐tests, and responder‐rate calculations based on a minimum clinically important difference (MCID) of at least 30% and substantial clinical benefit (SCB) improvement thresholds of 50% or greater.

Pain & Function Improve Significantly

Of 22 patients providing 12-month data, mean numeric rating scale pain scores decreased by 43% from 7.1 (95% CI, 6.5–7.7) at baseline to 3.8 (95% CI, 2.5–5.1) at 12 months (P<0.001). Clinically significant pain relief was reported by 64% of patients (MCID), and 55% achieved SCB. Notably, 59% reached a patient-acceptable symptom state (NRS ≤ 3).

Functional improvement paralleled pain reduction. Mean ODI scores were halved—from 53 (95% CI, 48–59) to 24 (95% CI, 15–33; p < 0.001). At 12 months, 59% (13 of 22) of participants achieved at least a 30% improvement—the minimal clinically important difference—in back function. A notable shift in disability levels was observed: 82% of participants initially rated their disability as severe or crippled, but only 18% remained in those highest impairment categories at 12 months—a statistically significant improvement (P< 0.001).

Safety Profile

Six mild to moderate adverse events—three possibly related to the NP product and three to the procedure—were all resolved without long-term effects. One serious event (injection-site inflammation) was deemed procedure-related and also resolved. No secondary surgeries were needed.

Enormous Opportunity

“Minimally invasive intradiscal treatments represent an enormous opportunity to improve spine care by delaying or avoiding surgical intervention and enhancing quality of life in patients with discogenic back pain,” the researchers stated. “The results of this study provide additional evidence that supplementation of the degenerated intervertebral disc with intradiscally delivered allogeneic NP is associated with clinically significant pain palliation and functional improvement.”

The authors recommended further investigation into the clinical role of allogeneic NP supplementation for bridging the current treatment gap in chronic lumbar discogenic pain.