Delivery of Adipose Derived Stem Cells for Healing Surgical Hernia Repairs

描述（由申请人提供）：在美国，每年有超过70万例手术疝修补，尽管最近取得了进展，但复发率仍然很高。在这些手术中，有10万例是切口或内脏疝修复手术，每年花费1.7亿美元，复发率高达60%。结合生物相容性补片加强腹筋膜在外科疝修补中已在很大程度上取代了高压缝合技术。目前，首选的生物材料包括耐用的合成网，它承担了永久性异物的所有缺陷；可吸收的网状物不能提供足够的长期支撑；或者生物修复术，它是生物可吸收的，但仍然以令人无法接受的高失败率导致复发性疝气。因此，外科医生只能在糟糕的修复方案中做出选择。我们的目标是通过使用含有脂肪源性干细胞（ASCs）的生物修复术来加速疝修复后的愈合速度。ASCs于2001年被发现，并已用于许多适应症的细胞治疗，包括骨折，心肌修复和软组织修复。它们的促愈合功能主要是通过在损伤部位分泌的旁分泌因子来促进血管形成和组织重塑。该产品将是一种即时护理的ASC种子生物假体，将促进更快的愈合时间，防止感染，并留下生物修复。我们的生物假体旨在防止切口疝的复发，从而减少住院随访护理，额外的手术和患者的痛苦。

DESCRIPTION (provided by applicant): Over 700,000 surgical hernia repairs are performed each year in the United States and despite recent advances, a significant rate of recurrence persists. Of these surgeries, 100,000 are for incisional or visceral hernia repairs, which cost 1.7B annually and have a recurrence rate that can be up to 60%. The incorporation of biocompatible mesh to strengthen the abdominal fascia has largely replaced high-tension suturing techniques in surgical hernia repair. Currently, the preferred biomaterials include durable synthetic mesh, which bears all the pitfalls of a permanent foreign body; absorbable mesh which does not provide enough long- term support; or bioprosthetics, which are bioabsorbable but still fail at an unacceptably high rate causing recurrent hernias. Surgeons are therefore left to choose between poor options for a repair. Our goal is to accelerate healing rates after hernia repair by using bioprosthetics containing adipose-derived stem cells (ASCs). ASCs were identified in 2001, and have been used for cell therapy in many indications including bone fractures, myocardial repair and soft tissue repair. Their prohealing function is largely mediated through paracrine factors secreted at the site of injury to promote vascularization and tissue remodeling. The product will be a point-of-care ASC seeded bioprosthetic that will promote faster healing times, prevent infection, and leave a biologic repair. Our bioprosthetic is designed to prevent recurrence of incisional hernias, thereby reducing inpatient follow-up care, additional surgeries, and patient distress.