Treating Degenerative Disc Disease At Its Core
Clinical Trials Investigate Injectable Cell-Based Therapy For Back Pain

Dom Coric, MD, explains the research currently underway on injectable cell-based therapy to repair spinal discs.
Each year, nearly one million people undergo surgery to relieve back pain due to degenerative disc disease. While these discectomy and spinal fusion procedures can be effective in reducing pain by enhancing and supporting the vertebral structure, surgery does not address the underlying problem.

What if there was a way to heal a damaged disc and prevent future degeneration? This is the question at the heart of a phase II clinical trial taking place at Carolina Neurosurgery & Spine Associates for NuQu®, an injectable, cell-based therapy for treating degenerative disc disease. The practice also participated in a phase I trial that was completed with positive results.

"This cell-based technology is very promising and is potentially transformational for a very large patient population, enabling pain relief without an invasive surgical procedure," said lead clinical investigator Dom Coric, MD, of Carolina Neurosurgery & Spine Associates.

How A Disc Degenerates
The intervertebral disc is a fibro-cartilaginous structure that consists of an outer annulus, which provides tensile strength, and an inner nucleus, which resists compressive forces. The cartilage cells that make up the disc produce extracellular matrix (ECM), which is crucial to the health of the disc.

Degenerative disc disease occurs as the body ages and a disc's cells are unable to produce and maintain ECM. Over time this leads to diminished disc height, increases stress on and damage to surrounding vertebral structures, and ultimately results in back pain.

For many patients, spinal fusion continues to be an effective treatment for severe lower back pain due to disc degeneration. Fusion involves removing the affected disc and using instrumentation to fuse the adjacent vertebrae. While pain usually decreases after fusion, the procedure limits a patient's motion and puts stress on vertebrae around the fused area. This can lead to the need for additional surgery in the future. Total disc replacement surgery is another option for treating degenerative disc disease. While the procedure is designed to maintain a patient's motion, it is still a very invasive surgery that involves removing the majority of the diseased disc.

Healing The Diseased Disc
Emerging technologies seek to directly treat the diseased disc. One category, known as nucleus repair, involves introducing biologically active material into the disc to replenish cells or increase production of ECM. This is the goal of NuQu, the cell-based therapy currently being studied at Carolina Neurosurgery & Spine Associates.

NuQu technology uses juvenile cartilage cells, which possess a significantly higher capacity to renew and restore healthy tissue. The juvenile cells are supplied frozen to the physician and then thawed and combined with a fibrin carrier at the time of use. The cells are injected into the center of the disc space under 2D-fluoroscopic guidance using a 22-gauge needle.

"The potential to repair and restore spinal discs would be
revolutionary, and our practice is honored to play a part in
advancing this technology." - Dom Coric, MD

Encouraging Results
In the initial study,* NuQu appeared to restore both nucleus structure and disc height. Patients were treated with a single injection and experienced statistically significant improvements from baseline on all clinical scales (ODI-disability scale, NRS-pain scale, and SF-36). There was MRI improvement in 77% of patients imaged at six months and 62% of patients imaged at 12 months. The treatment appeared to be safe, with no participants experiencing neurological deterioration, there were no disc infections, and there were no serious and unexpected adverse events. Lab studies indicated no immunological response to the NuQu treatment. A second multicenter trial utilizing NuQu and led by Dr. Coric is currently under way at our practice.** Those patients who qualify for the study receive the NuQu injection or a placebo and will be monitored for three years.

To learn more about our research efforts or spine treatment options, call 704-376-1605.

*An Open Label I/II Pilot Study to Evaluate the Treatment of Degenerative Lumbar Discs with Allogeneic Cultured Chondrocytes
**A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Treatment of Degenerative Lumbar Discs with Allogeneic Cultured Chondrocytes

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