Clinical Study of Sustained-Release Implant for Trauma Repair
Abstract
This work directly addresses the Peer Reviewed Medical Research Program (PRMRP) Topic Area Orthopaedic Medicine - Sustained Release Drug Delivery. We specifically address the following PRMRP Strategic Goals: Prevention - Develop strategies for improved care at point of injury to prevent musculoskeletal disorder onset Treatment - Develop and test strategies to increase quality of life or halt/slow disease progression, including regenerative medicine approaches and biologics for associated musculoskeletal disorders. Our work targets the treatment of spinal disc degeneration that commonly occurs as a result of injury or trauma from training or combat. Spinal disc degeneration can also be non-impact related, and it affects a large number of active military and veterans. The disc degeneration condition is painful and can be treated vertebral spinal fusion. By improving the success rate and enabling faster fusion rates for spinal fusions, it could be possible to increase the readiness to deploy of active military affected by this pathology. Bone morphogenetic protein-2 (BMP2) is the most potent bone-inducing agent identified to date. However, its use has suffered setbacks due to serious safety concerns. We have developed a variant of BMP2 called AMP2 that binds very tightly to implant materials. Using this technology, we have created resorbable implants that are surface-coated with AMP2 that retain the biologic at the implant site over the extended period of time required to achieve a lasting therapeutic effect. This permits precise delivery of bone-healing bioactivity that eliminates the risk of off-target effects. The release of AMP2 from the implant is synchronized with implant resorption, thus producing robust bone formation. We used this technology to develop a product called OsteoAdapt SP, the first biological device of its kind. We have validated OsteoAdapt SP in models of long-bone repair in rodents, goats, and sheep (vertebral interbody application) and demonstrated superiority over the current best treatments available. Objective: Our objective is to complete Feasibility clinical studies of OsteoAdapt SP to demonstrate safety for utilization in single level TLIF spinal fusion procedures. This will enable Pivotal clinical studies in order to gain U.S. Food and Drug Administration approval with the goal of making this treatment available to Service Members in need. Clinical Impact and Relevance to Military Health: The single biggest impact of our product is to increase readiness and accelerate return to duty. The immediate impact it can offer to patients and healthcare providers is a faster bone healing rate, resolution of degenerative disc disease (DDD), higher resolution of non-fusions, shorter length of stay, lower infection rates and better quality of life. The long-term impact is a significant cost saving for the entire healthcare system. Patients with non-healing bone injuries (non-unions) or with lower back pain from DDD have been found to be more likely to use various types of surgical care, inpatient care and outpatient physical therapy than those without non-unions. Non-Unions and DDD surgery often require revision surgeries to achieve fusion if they fuse at all, resulting in lifelong pain and disability. In addition, patients are much more likely to be prescribed pain medications, especially strong opioids and had longer length of opioid therapy than patients without non-union. Improved methods to heal critical fractures and degenerative disc disease by promoting active bone regeneration will produce better outcomes and improve the health of our Service Members and Veterans.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310693
Entities
People
- Luis Alvarez
Organizations
- United States Army