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Quality Standards of Stem Cell Sources for Clinical Treatment of Neurodegenerative Diseases

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收录情况： ◇ SCIE

作者：

机构： [1]The Institute for Translational Medicine, Shandong University/Affiliated Second Hospital, Jinan, Shandong, China [2] The Institute for Tissue Engineering and Regenerative Medicine, Liaocheng University/Liaocheng People’s Hospital, Liaocheng, Shandong, China [3] Shenzhen Research Institute, Shandong University, Shenzhen, Guangdong, China [4] The Institute of Vascular Surgery, Capital Medical University/Xuanwu Hospital, Beijing, China [5] Zhengzhou Regogene Inc., Zhengzhou, Henan, China [6] Department of Neurosurgery, Tsinghua University Yuquan Hospital, Beijing, China

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关键词： Cell therapy Clinical application guideline Good Manufacturing Practice Neurorestoration Quality control

摘要：

A large number of experimental and clinical studies have shown that cell transplantation has therapeutic effects for PD, AD and other neurodegenerative diseases or damages. Good Manufacturing Practice (GMP) guidance must be defined to produce clinical-grade cells for transplantation to the patients. Standardized quality and clinical preparation procedures of the transplanted cells will ensure the therapeutic efficacy and reduce the side-effect risk of cell therapy. Here we review the cell quality standards governing the clinical transplantation of stem cells for neurodegenerative diseases to clinical practitioners. These quality standards include cell quality control, minimal suggested cell doses for undergoing cell transplantation, documentation of procedure and therapy, safety evaluation, efficacy evaluation, policy of repeated treatments, not charging the patients for unproven therapies, basic principles of cell therapy, and publishing responsibility. © 2020, Springer Nature Singapore Pte Ltd.

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出版当年[2019]版：

大类 | 4 区医学

小类 | 3 区生物学 4 区医学：研究与实验

最新[2023]版：

无

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出版当年[2018]版：

Q2 BIOLOGY Q3 MEDICINE, RESEARCH & EXPERIMENTAL

最新[2023]版：

无

影响因子： 0 最新[2023版] 0 最新五年平均 2.126 出版当年[2018版] 2.148 出版当年五年平均 1.76 出版前一年[2017版] 2.45 出版后一年[2019版]

第一作者：

第一作者机构： [1]The Institute for Translational Medicine, Shandong University/Affiliated Second Hospital, Jinan, Shandong, China [2] The Institute for Tissue Engineering and Regenerative Medicine, Liaocheng University/Liaocheng People’s Hospital, Liaocheng, Shandong, China [3] Shenzhen Research Institute, Shandong University, Shenzhen, Guangdong, China

通讯作者：

通讯机构： [1]The Institute for Translational Medicine, Shandong University/Affiliated Second Hospital, Jinan, Shandong, China [2] The Institute for Tissue Engineering and Regenerative Medicine, Liaocheng University/Liaocheng People’s Hospital, Liaocheng, Shandong, China [3] Shenzhen Research Institute, Shandong University, Shenzhen, Guangdong, China

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Quality Standards of Stem Cell Sources for Clinical Treatment of Neurodegenerative Diseases

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