新的微操作细胞法律框架扩大了俄罗斯细胞治疗的可能性。 - Suppr

The new legal framework for minimally manipulated cells expands the possibilities for cell therapy in Russia.

作者信息

Krasilnikova Olga A, Klabukov Ilya D, Baranovskii Denis S, Shegay Peter V, Kaprin Andrey D

机构信息

Department of Regenerative Technologies and Biofabrication, National Medical Research Radiological Center, Obninsk, Russia.

出版信息

Cytotherapy. 2021 Aug;23(8):754-755. doi: 10.1016/j.jcyt.2021.03.007. Epub 2021 May 10.

DOI:10.1016/j.jcyt.2021.03.007

PMID:33985904

Abstract

摘要

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The new legal framework for minimally manipulated cells expands the possibilities for cell therapy in Russia.新的微操作细胞法律框架扩大了俄罗斯细胞治疗的可能性。

Cytotherapy. 2021 Aug;23(8):754-755. doi: 10.1016/j.jcyt.2021.03.007. Epub 2021 May 10.

Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products.生物医学细胞产品的药品生产质量管理规范（GMP）的特异性

Bull Exp Biol Med. 2018 Mar;164(4):579-582. doi: 10.1007/s10517-018-4035-8. Epub 2018 Mar 4.

[Cell therapy for ischemic stroke. Results of clinical trials and perspectives of clinical application in the Russian Federation].[缺血性中风的细胞治疗。俄罗斯联邦的临床试验结果及临床应用前景]

Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(12. Vyp. 2):94-104. doi: 10.17116/jnevro201811812294.

[Ethical boundaries of the legal regulation of genome sequencing in Russia and abroad.].[俄罗斯及国外基因组测序法律监管的伦理边界。]

Klin Lab Diagn. 2020 Jun 4;65(7):458-463. doi: 10.18821/0869-2084-2020-65-7-458-463.

[Cell therapy of chronic heart failure: State of the art].[慢性心力衰竭的细胞治疗：现状]

Kardiologiia. 2018(S4):46-54.

[Recent results of Russian research in tissue therapy].[俄罗斯组织疗法研究的近期成果]

Ann Ocul (Paris). 1950 Nov;183(11):957-65.

[The use of blood preparations for stimulation of healing injured tissue (Review of Russian and foreign literature)].[使用血液制品刺激受伤组织愈合（俄罗斯和国外文献综述）]

Vestn Khir Im I I Grek. 1960 Mar;84:120-31.

[The resolution of the XXVIII (91th) session of the RAMS General Meeting "Cell Technologies and Regenerative Medicine"].[俄罗斯医学科学院第28届（第91次）大会“细胞技术与再生医学”会议决议]

Vestn Ross Akad Med Nauk. 2013(9):4-6.

Conceptual principles and patterns of legal regulation of the processes of storage, access and data protection of genome sequencing in foreign countries as the basis for the modernization of Russian legislation.国外基因组测序存储、访问和数据保护过程法律监管的概念原则和模式，为俄罗斯立法现代化提供了依据。

Klin Lab Diagn. 2020 Sep 16;65(9):580-586. doi: 10.18821/0869-2084-2020-65-9-580-586.

Sex workers, unite! (Litigating for sex workers' freedom of association in Russia).性工作者们，团结起来！（为俄罗斯性工作者的结社自由而诉讼）

Health Hum Rights. 2014 Dec 11;16(2):E24-34.

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Quality and Regulatory Requirements for the Manufacture of Master Cell Banks of Clinical Grade iPSCs: The EU and USA Perspectives.临床级诱导多能干细胞主细胞库生产的质量与监管要求：欧盟与美国视角

Stem Cell Rev Rep. 2025 Apr;21(3):645-679. doi: 10.1007/s12015-024-10838-9. Epub 2025 Jan 17.

Local Application of Minimally Manipulated Autologous Stromal Vascular Fraction (SVF) Reduces Inflammation and Improves Bilio-Biliary Anastomosis Integrity.微创处理的自体基质血管成分（SVF）局部应用可减轻炎症并改善胆-胆吻合口完整性。

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Pathologically altered articular cartilage attracts intense chondrocyte invasion into the extracellular matrix: in vitro pilot study.病理改变的关节软骨吸引软骨细胞大量侵入细胞外基质：体外初步研究。

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Stem Cells and Their Derivatives: Unlocking the Promising Potential of Minimally Manipulated Cells for Tissue Engineering.干细胞及其衍生物：解锁最小化操作细胞在组织工程中的广阔应用前景。

Cell Transplant. 2024 Jan-Dec;33:9636897231221846. doi: 10.1177/09636897231221846.

Intraoperative Creation of Tissue-Engineered Grafts with Minimally Manipulated Cells: New Concept of Bone Tissue Engineering In Situ.术中利用极少操作的细胞构建组织工程移植物：原位骨组织工程的新概念。

Bioengineering (Basel). 2022 Nov 17;9(11):704. doi: 10.3390/bioengineering9110704.

Adverse events, side effects and complications in mesenchymal stromal cell-based therapies.基于间充质基质细胞的疗法中的不良事件、副作用和并发症。

Stem Cell Investig. 2022 Nov 8;9:7. doi: 10.21037/sci-2022-025. eCollection 2022.

Minimally Manipulated Bone Marrow-Derived Cells Can Be Used for Tissue Engineering In Situ and Simultaneous Formation of Personalized Tissue Models.最小化处理的骨髓源性细胞可用于原位组织工程和同时形成个性化组织模型。

Bull Exp Biol Med. 2022 May;173(1):139-145. doi: 10.1007/s10517-022-05509-z. Epub 2022 May 27.

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The new legal framework for minimally manipulated cells expands the possibilities for cell therapy in Russia.

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