Elderly people are at great risk for bone fracture and they are more likely to suffer complications during fracturehealing. An inefficient healing process exposes the elderly to higher rates of delayed healing or nonunions. Theslow recovery after geriatric fractures dramatically increases risks of degenerative decline, morbidity, andmortality with a negative socio-economic impact. Available solutions to facilitate bone regeneration are eitherinvasive or show adverse events in aged people. Intravenous injectable Fibrinogen-coated Albuminnano-Spheres (FAS) are nanometer-sized spheres with a unique multivalent potential to accelerate chronicwound healing in multiple soft tissues. FAS has been shown to promote mobilization of progenitor cells of variouslineages 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 afterfracture 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 biologicalagent to accelerate the healing of fractured bones in geriatric patients. If successful, FPS could represent a newtherapeutic that can improve the health and functional independence of older adults. In this SBIR Phase I projectFibroplate aims to accomplish two objectives: 1) Demonstrate the efficacy of FPS in bone fracture healing inaged pre-clinical rat models. FPS will be administered after femur surgical fracture to assess the bone healingprocess through quantitative computed tomography, histological analysis, and biomechanical evaluation of bonestrength. 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 beperformed to establish metabolism, dose, and toxicity, together with a long-term assessment of the bone healingprocess. 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. PROJECT NARRATIVE
Fractures in elderly people are an important public health issue, especially as incidence increases with age, and
the population of elderly people is growing. Treatments to accelerate geriatric bone healing are missing, exposing
the elderly to a high risk of degenerative decline. Fibroplate is developing a new biological treatment that could
be easily administered to accelerate fracture healing in older adults and promote fast recovery. 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death risk ; endothelial stem cell ; endothelial progenitor cell ; Impaired healing ; Healing abnormal ; Healing delayed ;
