Izumi Kenji, Song Junhui, Feinberg Stephen E
Department of Oral and Maxillofacial Surgery, University of Michigan Medical Center, Ann Arbor, Mich., USA.
Cells Tissues Organs. 2004;176(1-3):134-52. doi: 10.1159/000075034.
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.
本出版物的主要目的是让读者了解制造一个获得美国食品药品监督管理局（FDA）批准的、用于重建手术临床试验的实验室生产的细胞基设备所需的复杂性和步骤。大多数基于组织工程的细胞基设备被视为“人类体细胞疗法”，受生物评估与研究中心（CBER）监管，并且被FDA视为组合产品。我们以我们体外生产的口腔黏膜等效物（EVPOME）为例，展示了遵循独立新药（IND）申请所需的流程，EVPOME是一种组织工程口腔黏膜，是一种在临床应用前需要FDA批准的细胞基设备。通过阐述实验方法并展示所得数据，我们试图解释我们在此过程中所涉及的每一步。
