Keratin Biomaterial-Based Bone Graft, KeraGenics Bone, for Military Bone Injuries
Abstract
Treatment options for traumatic bone injuries sustained by our Warfighters in combat and by civilians during trauma, accidents, or as a result of medical resection are not always safe or effective. This is particularly true for bone injuries that are so large they will not heal on their own, a common problem for a Soldier injured by blasts from improvised explosive devices (IEDs). Current options include using bone harvested from another bone in the patient s body (autograft) or using InFUSE, a collagen carrier of rhBMP-2. rhBMP-2 is a growth factor that encourages the body to regrow bone. By providing localized delivery of this growth factor, we are able to encourage the body to regrow the bone without the need for autograft. Complications associated with the current collagen carrier for rhBMP-2, InFUSE, are common. Thus, it is important to find an alternative carrier that can provide controlled release of rhBMP-2 for repair of these critical-sized defects without the adverse events associated with InFUSE. One potential alternative carrier to the collagen one used in InFUSE is a biomaterial called keratin. In initial testing, an injectable keratin hydrogel delivery system was used as the new delivery system for rhBMP-2. We were able to demonstrate that the keratin delivery system provided controlled release of rhBMP-2 for repair of critical-size defects without the complications associated with InFUSE. Based on the results from preclinical testing, we are confident that the product is ready to move into final animal model testing, which will support an Investigational Device Exemption (IDE) submission to the Food and Drug Administration (FDA). In this proposed project, we will begin by determining the appropriate amount of rhBMP-2 needed for healing when it is used in the keratin delivery system. Two different doses will be compared to a no-treatment control in a nonhuman primate model used for testing similar FDA-approved products. The optimal dose will then be used in a non-inferiority test of the keratin delivery system compared to InFUSE. We will also gather data needed for an additional test, called immunogenicity, which will make sure that keratin is unlikely to cause an immune response in someone treated with the keratin delivery system. Finally, in a proposed optional 6-month follow-on period of performance, we propose to gather everything necessary for an IDE and finalize the IDE submission. Successful completion of this project and subsequent approval of the new device by the FDA would result in a new and potentially safer option for healing critical sized defects in our Wounded Warriors and in civilians sustaining traumatic injury or undergoing surgical resection. Approximately a quarter of our Soldiers sustaining extremity trauma injuries experience a fracture, and the majority of these fractures are open fractures. This product may also prove to be beneficial to civilians who experience a bone fracture due to trauma or an accident. After initial approval, the indications for use for this product can be expanded with additional studies. By reducing the risk of ectopic bone formation or an immune response to the carrier, this product has the potential to aid in the healing of critical-size segmental bone defects, preventing amputation and increasing quality of life of affected individuals.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Apr 04, 2016
- Source ID
- W81XWH1510133
Entities
People
- Luke Burnett
Organizations
- KeraNetics (United States)
- United States Army