Title : A novel off-the-shelf therapy for full-thickness skin regeneration in an ischemic rabbit ear model
Skin is important as it provides a barrier to infection, prevents dehydration, and protects underlying soft tissue. Currently, there are very limited options to successfully treat full thickness skin defects from blasts, burns, and chronic wounds as a result of diabetic complication. Treatment options include skin grafts or skin flaps which cannot fully restore the skin function and integrity. Although, numerous strategies have been proposed to assist in chronic and traumatic wound healing, including growth factor delivery, the results are still in debate. Most recently, cell-based therapies have been investigated as a potential modality for the treatment of chronic wounds; however, standard guidelines for the use of cellular therapy in chronic wound healing have not been established. Furthermore, barriers to the use of stem cells hinder clinical application in terms of FDA regulation, cost, and potential risk of adverse effects. To address this unmet need in regenerative medicine, we have combined a novel exosome-based cell-free biomaterial, purified exosomal product (PEP) with an FDA-approved fibrin sealant – Tisseel. Exosomes are a class of extracellular vesicles that range from 40–120 nm in size. They contain bioactive cargos, including small non-coding RNA, surface receptors, free fatty acids, and proteins. Increasing evidence has demonstrated regenerative effects for neural, myocardial, hepatic, renal, cutaneous, skeletal, and chondral tissues.(references attached at the end) In this study, using a well-established ischemic rabbit ear model (rabbit ear references), we evaluated the skin regenerative benefits of PEP with Tisseel on ischemic wound beds.