Hunkeler D, Rehor A, Ceausoglu I, Schuldt U, Canaple L, Bernard P, Renken A, Rindisbacher L, Angelova N
Laboratory of Polyelectrolytes and BioMacromolecules, Swiss Federal Institute of Technology, Lausanne.
Ann N Y Acad Sci. 2001 Nov;944:456-71. doi: 10.1111/j.1749-6632.2001.tb03855.x.
The metrics used, thus far, to assess bioartificial organ function are shown to be subjective and requiring validation. Therefore, four categories of correlations are proposed based on, respectively, device, in vitro and in vivo evaluations, and clinical function. Examples are presented whereby the correlations among individual indicators are used as a means to expedite the development of immunoisolated cells. Specifically, a case study illustrating the validation of in vitro indicators of in vivo graft function for the bioartificial pancreas (microencapsulated islets) is summarized. This has revealed thresholds with respect to given metrics relating to in vivo device function, the necessity to couple bioartificial organ design with transplant site selection, as well as the lack of objectivity involved in the evaluation and establishment of hypotheses. Specific quantitative indicators illustrate the need for quality-controlled measures, for example, relating to the tolerance of microcapsule diameter and membrane thickness distributions. Qualitative indices representing fibrosis and device properties (e.g., sphericity) are also used to describe the need for in vitro experiments in the development of bioartificial organs.
迄今为止，用于评估生物人工器官功能的指标被证明具有主观性且需要验证。因此，基于设备、体外和体内评估以及临床功能分别提出了四类相关性。文中给出了示例，通过这些示例，个体指标之间的相关性被用作加速免疫隔离细胞开发的一种手段。具体而言，总结了一个案例研究，该研究说明了生物人工胰腺（微囊化胰岛）体内移植功能的体外指标的验证。这揭示了与体内设备功能相关的特定指标的阈值、将生物人工器官设计与移植部位选择相结合的必要性，以及评估和建立假设过程中缺乏客观性的问题。具体的定量指标说明了质量控制措施的必要性，例如，与微胶囊直径和膜厚度分布的耐受性有关的措施。代表纤维化和设备特性（如球形度）的定性指标也被用于描述生物人工器官开发中体外实验的必要性。
