期刊
REGENERATIVE MEDICINE
卷 4, 期 2, 页码 251-263出版社
FUTURE MEDICINE LTD
DOI: 10.2217/17460751.4.2.251
关键词
cell therapy; cGMP; good manufacturing practice; human embryonic stem cells; human neural stem cells; investigational new drug application; manufacturing neurons; master cell bank; neuroplasticity; product development; regulation of stem cell products; stroke
资金
- Russell and Elizabeth Siegelman
- Bernard and Ronni Lacroute
- William Randolph Hearst Foundation
- Edward G. Hills Fund
- NIH NINDS [RO1 NS27292, P01 NS37520, RO1 NS058784]
- NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE [R01NS058784, R01NS027292, P01NS037520] Funding Source: NIH RePORTER
Demographic trends, particularly those related to longer life expectancy, suggest that the demand for tissue and organ transplants will further increase since many disorders result from degeneration, injury or organ failure. The most urgent problem in transplantation medicine is the shortage or lack of suitable donor organs and tissue, leading to ethical and societal problems such as organ trafficking. The discovery of stem cells in the inner cell mass of developing embryos and in adult tissue has revolutionized the medical field by introducing new therapeutic dimensions to consider for previously untreatable diseases and injuries. The unlimited self-renewal ability and pluripotent capacity to become any cell type of the organism make human embryonic stem cells (hESCs) a compelling source of cells to study tissue histogenesis and to apply in a wide array of tissue engineering, cell transplantation therapy and drug discovery applications. In this article, we will focus on hESCs and address the derivation of therapeutic neural stem cell lines from hESCs, as well as the biological and regulatory aspects to developing a safe cellular product for stroke cell therapy.
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