PITA FY2014 Projects

Blood Plasma-Based Materials As Extenders and Enhancers to Substitute Bone Grafts

PI:Phil Campbell, ICES

University:Carnegie Mellon University

Co-PI(s):Lee Weiss, The Robotics Institute

Industry Affiliate(s):Carmell Therapeutics Corporation

Summary:Bone grafts and bone graft substitutes are the second most common type of tissue implant. Globally, approximately one million bone-grafting procedures are performed annually. Autografts harvested from the patient are the ‘gold standard’ for grafting, however the added surgical costs and risk of post-surgical donor-site complications associated with their use has led to a significant and growing market for bone graft substitute materials. For example, spinal fusion procedures typically use cadaver-sourced allograft bone or demineralized bone matrix (DBM) substitutes, or combinations thereof. However, neither allografts nor DBM are ‘standardized’ because there is donor-to-donor variability and vendor-to-vendor processing variations associated with their use. Furthermore, neither have the capacity to aid healing of soft tissue surrounding a bone defect site, which is an important factor in determining surgical outcomes. There are numerous other graft substitute products available, but no substitute has yet to meet clinical expectations. And, no ‘standards of care’ for substitute bone grafting exist. We propose to initiate development of a blood plasma-based material (PBM) to be used as a standardized extender to be mixed with these allogenic sourced materials in order to reduce outcome variability while also enhancing soft tissue healing. PBMs, which are currently being developed and commercialized by Carmell Therapeutics Corporation (a spin-out from Carnegie Mellon University), are off-the-shelf, low-cost, standardized bioactive biomaterials used to accelerate and enhance regeneration in tissue repair therapies. As a first step, we will formulate a PBM putty to be composited with DBM, and test these composites in an animal model. Our goal will be to determine the maximum ratio of a PBM/DBM composite than can induce equivalent bone quantity and quality as with DBM alone, while enhancing soft tissue repair.