Advanced Micro-patterned Wound Dressings for Enhanced Epithelialization

用于增强上皮化的先进微图案伤口敷料

• 批准号: 8832483
• 负责人: Chelsea M Magin
• 金额: $ 21.81万
• 依托单位: SHARKLET TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-18 至 2016-03-17
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8832483
• 关键词: Accident and Emergency department; Address; Adult; Affect; Age; Apical; Area; Autologous; Autologous Transplantation; Behavior; Biopsy; Blood Vessels; Burn injury; Businesses; Caring; Categories; Cells; Chronic; Chronic Disease; Cicatrix; Clinical Trials; Collaborations; Collagen; Comorbidity; Complex; Contracture; Data; Deposition; Dermal; Dermis; Epidermis; Epithelial; Epithelial Cells; Esthesia; Exhibits; Extracellular Matrix; Extracellular Matrix Proteins; Family suidae; Fibroblasts; Forearm; Foundations; Funding; Gold; Graft Rejection; Granulation Tissue; Healed; Histocompatibility Testing; Histologic; Human; Hydrogels; Incidence; Infection; Institutes; Laceration; Lead; Mission; Modeling; Monitor; Morbidity - disease rate; Myofibroblast; Necrosis; Numbness; Outcome; Pain; Patients; Pattern; Phase; Phenotype; Physiological; Plague; Population; Postoperative Period; Process; Pronation; Rattus; Relative (related person); Risk; Site; Skin; Skin graft; Small Business Innovation Research Grant; Speed; Sterile coverings; Surface; Surgical Flaps; Technology; Test Result; Testing; Thick; Time; Trauma; United States National Institutes of Health; Work; Wound Healing; Wrist; alternative treatment; base; cell motility; commercialization; cost; design; dexterity; experience; extracellular; graft failure; graft healing; head/neck injury; healing; improved; in vitro Model; industry partner; innovation; keratinocyte; manufacturing process; migration; neovascularization; pre-clinical; prototype; public health relevance; reconstruction; repaired; research and development; skin discoloration; standard care; success; wound

DESCRIPTION (provided by applicant): Nearly 12 million wounds are treated in U.S. emergency departments every year. Skin wounds such as severe burns, large trauma wounds, or non-healing/chronic wounds that are too extensive or complex to close by natural healing are often reconstructed using autologous skin grafts. Although autologous skin grafts are currently the gold standard in complex wound repair, there are significant rates of morbidities, including excessive pain and discomfort, risk of infection, loss of grafted skin, discoloration, scarring, an loss of sensation associated with both the graft and donor sites. This approach is also limited by the availability of healthy skin and is not a viable treatment option for severe burn patients. It s thus imperative to develop alternative treatments for large, full-thickness wounds. Sharklet Technologies, Inc. (STI) proposes to pursue innovative R&D focused on improving the treatment of full-thickness wounds, consistent with the mission of several institutes within the NIH. To overcome the limitations of current dressings and reduce the need for autologous skin grafts, STI proposes to develop an advanced, bilayer wound care dressing comprised of a vasoinductive, biodegradable matrix to promote healing of the dermis combined with a Sharklet micro-patterned apical layer to enhance autologous epidermal healing via guided cell migration into the wound site. Based on our preliminary data and evidence that microtopographies can guide migration of skin cells, we hypothesize that Sharklet micro-patterned surfaces can be optimized to accelerate wound closure through enhanced epithelialization-i.e., coverage by epithelial cells such as keratinocytes. To demonstrate the feasibility of this approach, the following Phase I SBIR Aims are proposed: AIM I - Demonstrate that Sharklet micro-patterns can increase healing rates in an in vitro model by at least 50% (pd0.05), relative to a smooth standard; and AIM II -Prove that Sharklet micro-patterned dressings reduce healing time by at least 25% (pd0.05) in a bipedicle ischemic rat skin flap model. The rat model we are using allows us to validate healing behavior for a broad range of non-healing/chronic wounds. Phase I success will lead to a larger Phase II SBIR project focused on validating and extending Phase I results into a porcine model that more closely mimics the healing of human skin. Phase II would also include optimization of manufacturing processes to produce the Sharklet-patterned prototype wound dressings. Phase II will be designed to provide the data needed to engage one or more Phase III commercialization partners by demonstrating the potential to develop an innovative product that uses proven and proprietary Sharklet micro- topographies to accelerate autologous wound healing. Phase III financial and industry partners will participate in and support follow-on clinical trials and commercialization. STI has demonstrated experience in commercializing SBIR-funded innovations via previous Phase III collaborations.

描述（由申请人提供）：每年在美国急诊室进行近1200万伤口。诸如严重烧伤，大创伤伤口或过于广泛或复杂而无法通过自然愈合关闭的非愈合/慢性伤口之类的皮肤伤口通常使用自体皮肤移植物重建。尽管自体皮肤移植物目前是复杂伤口修复中的金标准，但患病率很高，包括过度疼痛和不适，感染的风险，移植皮肤的丧失，变色，疤痕，与移植物和供体部位相关的感觉丧失。这种方法也受到健康皮肤的可用性的限制，对于严重烧伤患者而言，这不是可行的治疗选择。因此，必须为大而全厚的伤口开发替代治疗方法。 Sharklet Technologies，Inc。（STI）提议进行创新的研发，重点是改善全厚伤口的治疗，这与NIH内几家机构的任务一致。为了克服当前敷料的局限性并减少了对自体皮肤移植的需求，STI建议开发出一个先进的双层伤口护理护理敷料，包括由血管诱导的，可生物降解的矩阵组成的，以促进Dermis的愈合，结合使用Sharklet Micro-Paterned层，以增强自动性细胞的细胞迁移。基于我们的初步数据和微图可以指导皮肤细胞的迁移的证据，我们假设可以优化鲨鱼微图案表面，以通过增强的上皮层化加速伤口闭合，这是由上皮细胞（例如角质细胞）的覆盖范围。为了证明这种方法的可行性，提出了以下I期SBIR目标：目标I-证明鲨鱼微图案可以将体外模型中的愈合率提高至少50％（PD0.05），相对于平稳的标准； AIM II-在双皮亚缺血大鼠皮瓣模型中，鲨鱼微图案的敷料将愈合时间减少至少25％（PD0.05）。我们正在使用的大鼠模型使我们能够验证广泛的非治疗/慢性伤口的愈合行为。第一阶段的成功将导致一个更大的II期SBIR项目，该项目致力于验证和扩展I期结果，以更紧密地模仿人皮肤的愈合。第二阶段还将包括优化制造工艺以生产鲨鱼图案的原型伤口敷料。第二阶段将旨在通过证明开发一种使用经过验证且专有的鲨鱼微观形态来加速自体伤口愈合的创新产品来提供参与一个或多个参与一个或多个阶段的商业化伙伴所需的数据。第三阶段的金融和行业合作伙伴将参与并支持后续临床试验和商业化。 STI通过以前的III阶段合作展示了SBIR资助的创新方面的经验。