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从骨标本中分离并制备符合药品生产质量管理规范(GMP)级别的骨髓基质细胞

The Isolation and Manufacture of GMP-Grade Bone Marrow Stromal Cells from Bone Specimens.

作者信息

Dias Rhayra B, Bonfim Danielle C

机构信息

Research Division, National Institute of Traumatology and Orthopedics, Rio de Janeiro, Brazil.

Institute of Biomedical Sciences, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.

出版信息

Methods Mol Biol. 2021;2286:95-105. doi: 10.1007/7651_2020_319.

DOI:10.1007/7651_2020_319
PMID:33534112
Abstract

Bone marrow stromal cells (BMSCs, also known as bone marrow mesenchymal stem cells) are a plastic-adherent heterogeneous cell population that contain inherent skeletal progenitors and a subset of multipotential skeletal stem cells (SSCs). Application of BMSCs in therapeutic protocols implies its isolation and expansion under good manufacturing practices (GMP). Here we describe the procedures we have found to successfully generate practical BMSCs numbers, with preserved biological potency.

摘要

骨髓基质细胞(BMSCs,也称为骨髓间充质干细胞)是一类贴壁生长的异质性细胞群体,其中包含内在的骨骼祖细胞和一部分多能骨骼干细胞(SSCs)。在治疗方案中应用BMSCs意味着要在良好生产规范(GMP)下对其进行分离和扩增。在此,我们描述了已发现的能成功产生数量可观且生物学活性得以保留的BMSCs的方法。

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本文引用的文献

1
The Manufacture of GMP-Grade Bone Marrow Stromal Cells with Validated In Vivo Bone-Forming Potential in an Orthopedic Clinical Center in Brazil.在巴西一家骨科临床中心生产具有经过验证的体内成骨潜力的GMP级骨髓基质细胞。
Stem Cells Int. 2019 Nov 7;2019:2608482. doi: 10.1155/2019/2608482. eCollection 2019.
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Advances in stem cell research and therapeutic development.干细胞研究与治疗开发的进展。
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Intrathecal Injection of Allogenic Bone Marrow-Derived Mesenchymal Stromal Cells in Treatment of Patients with Severe Ischemic Stroke: Study Protocol for a Randomized Controlled Observer-Blinded Trial.
同种异体骨髓间充质干细胞鞘内注射治疗严重缺血性脑卒中患者的随机对照观察者盲法试验研究方案。
Transl Stroke Res. 2019 Apr;10(2):170-177. doi: 10.1007/s12975-018-0634-y. Epub 2018 May 23.
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Comparison of human bone marrow stromal cells cultured in human platelet growth factors and fetal bovine serum.人血小板生长因子与人胎牛血清培养的骨髓基质细胞比较。
J Transl Med. 2018 Mar 14;16(1):65. doi: 10.1186/s12967-018-1400-3.
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A Multicentric, Open-Label, Randomized, Comparative Clinical Trial of Two Different Doses of Expanded hBM-MSCs Plus Biomaterial versus Iliac Crest Autograft, for Bone Healing in Nonunions after Long Bone Fractures: Study Protocol.一项多中心、开放标签、随机、比较性临床试验:两种不同剂量的扩增人骨髓间充质干细胞加生物材料与髂嵴自体骨移植用于长骨骨折不愈合骨愈合的比较:研究方案
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6
Rationale and design of the Clinical and Histologic Analysis of Mesenchymal Stromal Cells in AmPutations (CHAMP) trial investigating the therapeutic mechanism of mesenchymal stromal cells in the treatment of critical limb ischemia.临床与组织学分析间充质基质细胞在截肢术(CHAMP)试验的基本原理和设计,该试验旨在研究间充质基质细胞治疗严重肢体缺血的治疗机制。
J Vasc Surg. 2018 Jul;68(1):176-181.e1. doi: 10.1016/j.jvs.2017.09.057. Epub 2018 Feb 1.
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Strategies to retain properties of bone marrow-derived mesenchymal stem cells ex vivo.体外保留骨髓间充质干细胞特性的策略。
Ann N Y Acad Sci. 2017 Dec;1409(1):3-17. doi: 10.1111/nyas.13451. Epub 2017 Oct 6.
8
Allogeneic Mesenchymal Stem Cells Ameliorate Aging Frailty: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial.异体间充质干细胞改善衰老虚弱:一项II期随机、双盲、安慰剂对照临床试验。
J Gerontol A Biol Sci Med Sci. 2017 Oct 12;72(11):1513-1522. doi: 10.1093/gerona/glx137.
9
From "Bench to Bedside": Current Advancement on Large-Scale Production of Mesenchymal Stem Cells.从“基础到临床”:间充质干细胞大规模生产的最新进展。
Stem Cells Dev. 2017 Nov 15;26(22):1662-1673. doi: 10.1089/scd.2017.0104.
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Human mesenchymal stem cells (MSCs) for treatment towards immune- and inflammation-mediated diseases: review of current clinical trials.用于治疗免疫和炎症介导疾病的人间充质干细胞:当前临床试验综述
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