Fluid Management System for Point of Care Device for Novel Regenerative Treatment for Chronic Wounds

项目摘要/摘要 医疗保险数据表明，超过800万受益人患有伤口或与伤口相关的感染 影响老年人的生活质量，估计该系统每年的成本在281亿至96.8B1美元之间。 开发新的治疗方法来处理慢性伤口是美国国立卫生研究院确定的优先事项 衰老。一种独特的FDA注册的再生产品，一种自体同源皮肤结构(AHSC) (SkinTE™，PolarityTE，Inc.，盐湖城，德克萨斯州)在治疗慢性伤口方面表现出了希望 包括压疮、糖尿病足部溃疡和下肢慢性创面。两个开放式标签单臂 初步研究表明，AHSC对治疗糖尿病足溃疡和静脉腿有疗效。 溃疡(VLU)2、3、4。在这些开放标签试验中，91%的DFU在8周内关闭，80%的VLU关闭 在一次治疗的12周内。目前，AHSC的临床应用需要分两步进行，首先 从患者身上采集全层皮肤，运往PolarityTE MD的生物制造 用于制造AHSC的设施，然后将其返回临床医生以应用于 伤口。这两个步骤的手术给农村社区的患者带来了挑战，他们必须长途跋涉 获得医疗保健的距离和第二次手术的返程。此外，越来越多的关闭 乡村医院正在减少农村获得医疗保健的机会，并更加重视门诊提供 关心。此外，市场研究表明，在临床医生办公室提供AHSC是按需提供的 将使潜在使用量增加7%。为了提供“按需”的AHSC，我们提出了 一种桌面、便携式、护理点(POC)设备，将允许在 门诊部、诊所或偏远医院。AHSC处理的关键步骤包括1)洗涤皮肤 收获以减少生物污染以及2)在组织中添加生物相容溶液来处理组织 创建AHSC并赋予某些所需特征的方式，包括某些处理 特点。这项建议解决了开发流体管理系统的技术挑战 确保达到生物降解率和AHSC粘度的制造要求的POC。 目前，生物污染物是通过一系列人工清洗步骤来减少的。特定的目标1将设计和 测试符合或超过生物负荷再教育要求的自动洗涤系统 当前的制造工艺。该系统必须能够交换大量的流体 皮肤采集，然后在废物容纳室收集液体。特定的AIM 2将设计和测试一个 流体管理系统，可以评估AHSC粘度并调整在以下过程中使用的生物相容性液体水平 加工要满足产品的粘度要求，确保最佳的搬运特性。

PROJECT SUMMARY/ABSTRACT Medicare data indicates that more than 8 million beneficiaries had a wound or wound-related infection impacting quality of life of seniors and estimated costs to the system of between $28.1B to $96.8B1 annually. Development of novel treatments to address chronic wounds is an identified priority for the National Institute of Aging. A unique FDA-registered regenerative product, an autologous homologous skin construct (AHSC) (SkinTE™, PolarityTE, Inc., Salt Lake City, UT) has shown promise for the treatment of chronic wounds including pressure ulcers, diabetic foot ulcers and lower extremity chronic wounds. Two open-label single arm pilot studies have demonstrated the efficacy of the AHSC in treating diabetic foot ulcers and venous leg ulcers (VLU)2,3,4. In these open-label trials, 91% of DFUs closed within 8 weeks and 80% of VLU’s had closed within 12 weeks of a single treatment. Currently, clinical use of the AHSC requires a two-step procedure, first taking a full-thickness skin harvest from the patient, which is shipped to PolarityTE MD’s biomanufacturing facility where it is used to manufacture the AHSC, which is then returned to the clinician for application into the wound. This two-step procedure creates challenges for patients in rural communities who must travel long distances to access health care and return for the second procedure. Additionally, the increasing closure of rural hospitals is reducing rural access to health care and puts more emphasis on outpatient office delivery of care. Furthermore, market research has indicated that providing the AHSC “on-demand” in the clinician’s office will increase the potential usage by 7%. In order to provide “on-demand” AHSC, we propose the development of a table-top, portable, point-of-care (POC) device that would allow the manufacturing of AHSC in the outpatient office, clinic, or remote hospital. Critical steps for AHSC processing include 1) washing of the skin harvest to reduce bioburden and 2) processing the tissue with the addition of biocompatible solutions in a manner to create the AHSC and impart certain desired characteristics, including certain handling characteristics. This proposal addresses the technical challenges of developing a fluid management system of the POC to ensure the manufacturing requirements for bioburden reduction and AHSC viscosity are achieved. Currently bioburden is reduced through a series of manual washing steps. SPECIFIC AIM 1 will design and test an automated washing system that meets or exceeds the bioburden reeducation requirements of the current manufacturing process. The system must be capable of exchanging large volumes of fluid across the skin harvest and then collect the fluid in a waste containment chamber. SPECIFIC AIM 2 will design and test a fluid management system that can assess AHSC viscosity and adjust biocompatible fluid levels used during processing to meet the viscosity requirements of the product to ensure optimal handling characteristics.