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%发生足部溃疡，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愈合率提高到50%。本申请将研究一种新型微载体细胞治疗平台（RMCT平台）用于糖尿病足溃疡。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装置。 本I期研究的重点是解决伤口环境中角质形成细胞的活力和生物学状态问题。在应用于伤口后的不同时间检查存在的细胞数量、它们的活力和它们的生物活性将提供关于细胞状态的关键信息。I期研究将概述两个具体目标。 在目标1研究中，我们将收获与伤口组织接触长达7天的RMCT平台，并评估平台是否存在活的角质形成细胞。重要的是，我们认为了解伤口组织中细胞活力如何随时间变化，以优化这种新型治疗方法的使用。出于监管目的，了解异种移植细胞在用于伤口治疗的条件下发生了什么也是重要的。 目标2中描述的研究构成了我们用于表征在RMCT平台中暴露于伤口环境时人角质形成细胞功能的实验设计。研究表明，这种治疗促进了伤口愈合过程。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.