Technology

One of the major causes of lower back pain is intervertebral disc (IVD) degeneration also known as lumbar degenerative disc disease which often leads to disk herniation.  IVD results from the dehydration of the central nucleus pulposus (NP) which ultimately alters the biomechanics of the disc and eventually causes tears to form in the peripheral annulus fibrosus (AF). A current major surgical treatment for low back pain is discectomy which involves the surgical removal of NP or AF protrusions that are impinging on nerve roots causing pain. However, the procedure does not restore healthy biomechanics and is known to accelerate degeneration in the long term. Tissue engineering with adipose-derived mesenchymal stem cells (ADMSCs) is being investigated as treatment for disc degeneration and has been mainly focused on repairing the NP in early to mid-stages of degeneration when the annulus is still competent. Scaffolds containing ADMSCs currently under investigation are injectable, so they can be implanted into the intradiscal environment minimally invasively, through a small gauge needle. Recent in vivo animal studies on NP tissue engineering with injectable scaffolds have shown low transplanted cell numbers post-implantation. A possible reason for these low numbers could be attributed to leakage of the scaffolds from the disc space through the needle tract. In addition, other recent clinical evidence suggests that small needle punctures, like those created by scaffold insertion, can accelerate disc degeneration.  Thus, there still remains a need to create efficacious treatments for IVD.

As a possible solution, the inventors have described a novel sealant device that forms a space-filling tissue engineering scaffold with adhesive properties that can stay anchored in the NP and AF of an IVD. The scaffold material can be applied in vivo in a single step to fill defects in the AF and NP during discectomy or during the implantation of a NP repair scaffold. The novel material localizes encapsulated cells (ADMSCs) by preventing leakage due to its adhesive properties and support in situ site-specific differentiation of the cells toward AF or NP phenotype. This IVD implant will be the first injectable scaffold designed to be implanted in both NP and AF defects in a single step. It has the potential to improve long-term outcomes of discectomy and enhance the clinical feasibility of NP regeneration strategies.

Potential Application

Aid in the diagnosis and treatment of intervertebral disc (IVD) degeneration.

Opportunity

The prevalence of back pain increases with age and lifetime recurrence is as high as 85%. Chronic IVD is the most common cause of disability in the 45-65 years age group while some degree of disc degeneration can be observed in most adults. Since back pain has wide spectrum of etiologies, IVD is generally realized in 20% patients. The most common cause of IVD who had lumbar disc herniation was sprain/strain (48.8%) in age group of <30years, heavy working (63.2%) in those between 30-44 years of age, and osteoporosis (62.8%) in those > 45years of age.

Rowan University is looking for a partner for further development and commercialization of this technology through a license.