Development of a tissue-engineered human oral mucosa: From the bench to the bed side
Development of a tissue-engineered human oral mucosa: From the bench to the bed side
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DOI：
10.1159/000075034
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发表时间：
2004-01-01
影响因子：
2.7
通讯作者：
Feinberg, SE
中科院分区：
文献类型：
--
作者：
Izumi, K;Song, JH;Feinberg, SE
本出版物的主要目的是使读者了解制造食品药品监督管理局（FDA）批准的实验室生产的细胞基器械所需的复杂性和步骤，用于重建手术的临床试验。大多数基于组织工程细胞的设备被认为是“人体细胞疗法”，属于生物评估和研究中心（CBER）的赞助范围，并被FDA视为组合产品。我们已经通过使用我们的离体生产的口腔粘膜等同物（EVPOME）（一种组织工程化口腔粘膜），作为在临床应用之前需要FDA批准的基于细胞的设备的示例，说明了遵循独立新药（IND）申请所必需的算法。通过举例说明实验方法和呈现结果数据，我们试图解释沿着我们解决的每一个步骤。版权所有（C）2004 S. Karger AG，巴塞尔。
The main objective of this publication is to make the reader aware of the complexity and steps that are necessary to make a Food and Drug Administration (FDA)-approved laboratory produced cell-based device, for use in clinical trials for reconstructive surgery. Most tissue-engineered cell-based devices are considered as 'human somatic cell therapy' and fall under the auspices of the Center of Biologic Evaluation and Research (CBER) and are considered a combination product by the FDA. We have illustrated the algorithm that is necessary to follow an Independent New Drug (IND) application by using our ex vivo produced oral mucosa equivalents (EVPOME), a tissue-engineered oral mucosa, as an example of a cell-based device that needs FDA approval prior to clinical application. By illustrating the experimental approach and presenting resulting data we attempt to explain each step that we address along the way. Copyright (C) 2004 S. Karger AG, Basel.