Cardiff Fetal Tissue Bank: Quality assured tissue for biomedical research and clinical trial in neurodegenerative disease

CFTB和SWIFT组织库从选择性终止妊娠(“堕胎”)的组织产品中收集人类胎儿组织。在同意过程中，我们为退行性脑部疾病患者开发新疗法的研究计划的目的已得到充分解释，并要求妇女将她们的组织捐赠给这些研究计划。知情同意程序是由国家研究伦理服务机构批准的。两家银行的主要区别在于收集组织的目的不同，因此使用的过程的无菌程度也不同。SWIFT组织库的运作是“研究级”程序，用于在实验室中安全处理研究组织。收集的组织随后被我们自己和其他经批准的计划用于广泛的研究，包括人类大脑和身体的发育，了解人体正常细胞和器官的组织和功能，包括脑、肺、肾、眼和脊髓，培养皿中的组织和功能，以及通过移植在脑、眼和脊髓疾病的动物模型中开发新的治疗方法。这些计划的一个主要子集侧重于了解干细胞的发育和分化为适合下一代细胞疗法的不同细胞命运。相反，CFTB在严格受控的洁净室环境中，在完全定义的无菌程序下运行到“临床级别”，并获得人类组织管理局的许可，提供临床级别的细胞供“人类使用”，包括用于患有一系列神经退行性疾病的患者的细胞移植。目前，我们正在处理用于脑移植的胎儿脑细胞，用于帕金森氏病的临床试验，恢复亨廷顿氏病的试验，并准备推出一项治疗癫痫的新计划。每一项新的临床应用都需要在所有组织过程中进行单独的临床前测试、验证和培训，并获得管理局的单独许可。因此，CFTB/SWIFT联合设施为基础研究和临床试验使用提供高质量的研究和临床级细胞和组织提供独特的全国资源。虽然我们的设计目的是为神经退行性疾病的原发和干细胞移植提供我们自己的计划，但我们试图通过向英国和欧洲的20多个其他研究计划和中心提供专门的组织来最大化该设施的效用和价值。研究结果的影响来自组织被放入的不同研究，如果没有质量保证的基础设施来供应CFTB/SWIFT提供的源组织，这些研究结果都是不可能的。

The CFTB and SWIFT tissue banks collect human fetal tissues from the tissue products resulting from elective termination of pregnancy ("abortions"). In the consent process, the purposes of our research programmes to develop new therapies for patients with degenerative brain diseases are fully explained, and the women are asked to donate their tissues to these research programmes. The informed consent procedures are approved by the national research ethics service.The principal difference between the two banks lies in the purposes for which tissue is collected, and hence the degree of sterility of the processes used. The SWIFT tissue bank operates to "research grade" procedures for safe handling of research tissues in the laboratory. Collected tissue is then used by ourselves and other approved programmes for a wide range of studies including human brain and body development, understanding the organisation and function of normal cells and organs of the body including brain, lung, kidney, eye and spinal cord, in the culture dish and the development of new therapies by transplantation in animal models of brain, eye and spinal cord disease. A major subset of these programmes focus on understanding the development and differentiation of stem cells into different cell fates appropriate for the next generation of cell therapies.Conversely, the CFTB operates to "clinical grade" under fully defined sterile procedures, in a rigorously controlled cleanroom environment, and is licenced by the Human Tissue Authority to supply clinical grade cells for "human use" including for cell transplantation in patients with a range of neurodegenerative diseases. At present we are processing fetal brain cells for brain transplantation in clinical trials in Parkinson's disease, to resume trials in Huntington's disease, and preparing to launch a new programme in epilepsy. Each new clinical application requires separate preclinical testing, validation and training in all tissue processes, and separate licencing by the Authority.Thus the combined CFTB / SWIFT facility provides a unique national resource for supplying high quality research and clinical grade cells and tissues originating from the human embryo, both for fundamental research and for clinical trial use. Although designed to supply our own programmes in primary and stem cell transplantation in neurodegenerative disease, we seek to maximise the utility and value of the facility by supplying specialist tissues to over 20 other research programmes and centres in the UK and Europe.The impact of the research results from the different studies to which the tissue is put, none of which would be possible without the quality-assured infrastructure to supply the source tissues that the CFTB/SWIFT provides.