Safety and efficacy of intradiscal nucleus pulposus allograft versus sham for lumbar discogenic pain associated with degenerative disc disease: study protocol for a randomized clinical trial

Chronic low-back pain is a leading cause of global disability, with degenerative disc disease (DDD) recognized as a common structural contributor. While conservative therapies may provide temporary symptom relief, they do not address the underlying degeneration of the intervertebral disc. Surgical interventions, such as spinal fusion or total disc replacement, are invasive procedures that permanently alter the anatomical structure of the vertebral motion segment. Minimally invasive intradiscal therapies have the potential to bridge the treatment gap between non-surgical management and surgery. Intradiscal delivery of nucleus pulposus (NP) allograft is intended to structurally supplement the degenerating disc and restore native disc function. Preliminary studies have suggested that a single intradiscal administration of NP allograft (VIA Disc NP) may improve pain and function in patients with lumbar discogenic pain.

This is a randomized, double-blind, sham-controlled, multi-center clinical trial designed to evaluate the safety and efficacy of VIA Disc NP. Eligible participants are 22 to 85 years of age with MRI-confirmed lumbar DDD (modified Pfirrmann grade 3–7), axial low-back pain of at least 6 months’ duration, and functional impairment unresponsive to conservative treatment. Participants are randomized in a 2:1 ratio to receive either a single injection of VIA Disc NP or a sham procedure. The primary efficacy endpoint of this superiority trial is the proportion of participants achieving a ≥ 30% reduction in back pain severity at 12 months. Secondary endpoints include functional improvement (ODI), quality-of-life measures (EQ-5D-5L, PGIC), and opioid reduction. Sham participants who remain symptomatic at 12 months may cross over to receive active treatment.

This trial will provide level-1 evidence of the safety and efficacy of supplemental NP allograft therapy in patients with moderate to severe lumbar discogenic pain. If successful, this approach may offer a minimally invasive, durable, and structure-preserving treatment alternative to spinal fusion or disc arthroplasty in a population with limited therapeutic options.

This trial is prospectively registered at ClinicalTrials.gov (Identifier: NCT06778447). Registered on January 16, 2025