Future research and therapeutic applications of human stem cells: general, regulatory, and bioethical aspects.
Future research and therapeutic applications of human stem cells: general, regulatory, and bioethical aspects.
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DOI：
10.1186/1479-5876-8-131
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发表时间：
2010-12-10
影响因子：
7.4
通讯作者：
Liras A
中科院分区：
文献类型：
--
作者：
Liras A
关于干细胞的具体特征以及基于此类细胞（胚胎干细胞和成体干细胞）的新药对于多种治疗适应症（心血管和缺血性疾病、糖尿病、造血系统疾病、肝脏疾病）的功效和安全性，还有很多需要研究的地方。随着人类体细胞细胞核转移以及 iPSC 技术的最新进展，已经允许获得与供体患者基因相同的所有三个胚层谱系，从而可以安全移植器官组织特异性成体干细胞，而不会产生免疫排斥。主要目标是需要扩展干细胞特性，以最大限度地提高干细胞功效（即干细胞的正确选择）以及干细胞衍生药物的功效（最大效果）和安全性。细胞治疗中需要考虑的其他因素包括基础设施和技术人员的适用性、生物材料、生产成本、生物样本库、生物安全和生物技术行业。未来几年干细胞研究领域的总体目标涉及确定治疗靶点和潜在的治疗测试、细胞分化和生理机制的研究、多能干细胞的培养条件以及在相应的临床试验中在动物和人体模型中进行的基于干细胞的药物或程序的功效和安全性测试。需要一个监管框架来确保患者能够获得产品以及政府对其监管和控制的援助。随着时间的推移，冷冻保存的科学和治疗相关性以及成本将需要生物伦理方面的考虑，但特别是对于最终可能作为胚胎干细胞来源用于研究的科学用途的胚胎，在这种情况下，生物伦理冲突可能会进一步加剧。
There is much to be investigated about the specific characteristics of stem cells and about the efficacy and safety of the new drugs based on this type of cells, both embryonic as adult stem cells, for several therapeutic indications (cardiovascular and ischemic diseases, diabetes, hematopoietic diseases, liver diseases). Along with recent progress in transference of nuclei from human somatic cells, as well as iPSC technology, has allowed availability of lineages of all three germ layers genetically identical to those of the donor patient, which permits safe transplantation of organ-tissue-specific adult stem cells with no immune rejection. The main objective is the need for expansion of stem cell characteristics to maximize stem cell efficacy (i.e. the proper selection of a stem cell) and the efficacy (maximum effect) and safety of stem cell derived drugs. Other considerations to take into account in cell therapy will be the suitability of infrastructure and technical staff, biomaterials, production costs, biobanks, biosecurity, and the biotechnological industry. The general objectives in the area of stem cell research in the next few years, are related to identification of therapeutic targets and potential therapeutic tests, studies of cell differentiation and physiological mechanisms, culture conditions of pluripotent stem cells and efficacy and safety tests for stem cell-based drugs or procedures to be performed in both animal and human models in the corresponding clinical trials. A regulatory framework will be required to ensure patient accessibility to products and governmental assistance for their regulation and control. Bioethical aspects will be required related to the scientific and therapeutic relevance and cost of cryopreservation over time, but specially with respect to embryos which may ultimately be used for scientific uses of research as source of embryonic stem cells, in which case the bioethical conflict may be further aggravated.
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影响因子：
64.8
作者：
Alvarez-Dolado, M;Pardal, R;Alvarez-Buylla, A
通讯作者：
Alvarez-Buylla, A
影响因子：
11.2
作者：
Bang, OY;Lee, JS;Lee, G
通讯作者：
Lee, G
影响因子：
3.2
作者：
Baum, Christopher
通讯作者：
Baum, Christopher
影响因子：
2.1
作者：
Chagastelles, Pedro Cesar;Nardi, Nance Beyer;Camassola, Melissa
通讯作者：
Camassola, Melissa
影响因子：
5.3
作者：
Docheva D;Popov C;Mutschler W;Schieker M
通讯作者：
Schieker M