Cell Viability on a Novel Cell-Therapy Platform

描述(由申请人提供)：在2000万美国糖尿病患者中，10%的人患足部溃疡，截肢风险增加16倍。使用生长因子和皮肤替代品的新临床疗法将治愈率提高到50%。一种新型的微载体细胞治疗平台(RMCT平台)将在这一应用中被研究用于糖尿病足部溃疡的治疗。与目前可用的皮肤替代品相比，微载体细胞治疗平台是一种简单的制造和应用设备。 在这个第一阶段的提案中提出的研究重点是解决伤口环境中角质形成细胞的活性和生物学状态的问题。在创面应用后的不同时间，检测存在的细胞数量、它们的活性和生物活性将提供关于细胞状态的关键信息。第一阶段的研究将在两个具体目标中概述。 在目标1的研究中，我们将采集与伤口组织接触长达7天的RMCT平台，并评估这些平台是否存在存活的角质形成细胞。我们认为，为了优化这一新的治疗方法的使用，了解伤口组织中细胞活性随时间的变化是很重要的。出于调控的目的，了解异种移植细胞在伤口治疗中使用的条件下会发生什么也很重要。 目标2中描述的研究构成了我们的实验设计，用于表征在RMCT平台中暴露于创伤环境中的人角质形成细胞的功能。研究表明，这种治疗促进了伤口的愈合过程。这些研究概述了如何实现这一目标的初步努力。

DESCRIPTION (provided by applicant): Of the 20 million American diabetics, 10% develop foot ulcers with a 16-fold increase risk of amputation. New clinical therapies with growth factors and skin substitutes have increased healing rates to 50%. A novel microcarrier cell-therapy platform (RMCT platform) will be investigated in this application for the use on diabetic foot ulcers. The microcarrier cell-therapy platform is a simple manufacturing and application device when compared to the skin substitutes currently available. The focus of the research proposed in this Phase I proposal is to address the issue of keratinocyte viability and biological status in the wound environment. Examining the number of cells present, their viability and their biological activities at various times after application to the wound will provide key information on the status of the cells. The Phase I studies will be outlined in two specific aims. In Aim 1 studies, we will be harvesting RMCT platforms that have been in contact with wound tissue for up to seven days and evaluating the platforms for the presence of viable keratinocytes. It is important, we believe to know how cell viability changes over time in the wound tissue in order to optimize the use of this novel therapeutic approach. It is also important for regulatory purposes to know what happens to the xenografted cells under the conditions of use in wound treatment. The studies described in aim 2 constitute our experimental design for characterizing the function of human keratinocyte function when exposed to the wound environment in RMCT platforms. Studies have shown that such treatment promotes the wound-healing process. These studies outline initial efforts for looking at how this may come about.