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（“流产”）产生的组织产品中收集人类胎儿组织。在同意过程中，充分说明了我们为患有退行性脑疾病的患者开发新疗法的研究方案的目的，并要求妇女将其组织捐赠给这些研究方案。知情同意程序由国家研究伦理服务中心批准。这两个库的主要区别在于收集组织的目的，因此所用过程的无菌程度不同。SWIFT组织库按照“研究级”程序在实验室安全处理研究组织。收集的组织然后被我们自己和其他批准的项目用于广泛的研究，包括人类大脑和身体发育，了解正常细胞和身体器官的组织和功能，包括脑、肺、肾、眼和脊髓，在培养皿中，以及通过在脑、眼和脊髓疾病的动物模型中移植来开发新的治疗方法。这些计划的一个主要子集集中在了解干细胞的发育和分化成适合下一代细胞治疗的不同细胞命运。相反，CFTB在完全定义的无菌程序下，在严格控制的洁净室环境中运作到“临床级”，并获得人类组织管理局的许可，提供“人类使用”的临床级细胞，包括用于一系列神经退行性疾病患者的细胞移植。目前，我们正在处理胎儿脑细胞，用于帕金森氏病的脑移植临床试验，恢复亨廷顿氏病的试验，并准备启动一个新的癫痫项目。每个新的临床申请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，并由管理局单独颁发许可证。因此，CFTB / SWIFT联合设施提供了一个独特的国家资源，为基础研究和临床试验使用提供高质量的研究和临床级人类胚胎细胞和组织。虽然我们的目的是为神经退行性疾病的原代和干细胞移植提供自己的项目，但我们寻求通过向英国和欧洲的20多个其他研究项目和中心提供专业组织来最大化该设施的效用和价值。来自不同研究的研究结果的影响，如果没有质量保证的基础设施来提供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.