FDA, Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue and Gene Therapies, Rockville, MD 20852, USA.
Xenotransplantation. 2010 Sep-Oct;17(5):329-37. doi: 10.1111/j.1399-3089.2010.00592.x.
The use of xenogeneic porcine pancreatic islets has been shown to be a potentially promising alternative to using human allogeneic islets to treat insulin-dependent type 1 diabetes (T1D). This article provides an overview of the existing FDA regulatory framework that would be applied to the regulation of clinical trials utilizing xenogeneic porcine pancreatic islets to treat T1D.
异种猪胰岛的应用已被证明是一种有潜力的替代方法，可以替代使用人同种异体胰岛来治疗胰岛素依赖型 1 型糖尿病 (T1D)。本文概述了现有的 FDA 监管框架，该框架将适用于利用异种猪胰岛治疗 T1D 的临床试验的监管。
