Fibrinogen coated albumin spheres to accelerate bone healing in older adults.

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PROJECT SUMMARY Elderly people are at great risk for bone fracture and they are more likely to suffer complications during fracture healing. An inefficient healing process exposes the elderly to higher rates of delayed healing or nonunions. The slow recovery after geriatric fractures dramatically increases risks of degenerative decline, morbidity, and mortality with a negative socio-economic impact. Available solutions to facilitate bone regeneration are either invasive or show adverse events in aged people. Intravenous injectable Fibrinogen-coated Albumin nano-Spheres (FAS) are nanometer-sized spheres with a unique multivalent potential to accelerate chronic wound healing in multiple soft tissues. FAS has been shown to promote mobilization of progenitor cells of various lineages including Endothelial Progenitor Cells (EPCs), a cell population responsible also for bone regeneration, and to counteract inflammatory states. Studies conducted on young rats showed that FAS administered after fracture promotes the superior strength and structure of the healed bone. By taking advantage of this knowledge, Fibroplate Inc. proposes to investigate the efficacy of Fibrinoplate-S (FPS), a FAS formulation, as a biological agent to accelerate the healing of fractured bones in geriatric patients. If successful, FPS could represent a new therapeutic that can improve the health and functional independence of older adults. In this SBIR Phase I project Fibroplate aims to accomplish two objectives: 1) Demonstrate the efficacy of FPS in bone fracture healing in aged pre-clinical rat models. FPS will be administered after femur surgical fracture to assess the bone healing process through quantitative computed tomography, histological analysis, and biomechanical evaluation of bone strength. 2) Confirm the mobilization of stem cells induced by FPS to delve deeper into the mechanism of action. This work will be preparatory of a Phase II project where an extensive IND-enabling preclinical study will be performed to establish metabolism, dose, and toxicity, together with a long-term assessment of the bone healing process. The final goal is to obtain FDA approval of FPS as a new healing agent in age-related bone fractures. By offering an effective treatment for frail patients, Fibroplate is expected to improve and promote healthy aging.