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现货的带血液中介细胞干细胞:生产,质量控制和临床使用

Tiziana Montemurro¹, Cristiana Lavazza¹, Elisa Montelatici¹

¹Unit of Cellular and Gene Therapy, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.

|June 26, 2024

概括

来自带血 (CB) 的介质体细胞 (MSC) 显示出治疗免疫媒介疾病的前景. 根据良好的制造实践 (GMP) 标准制造这些细胞支持临床试验和治疗用途,没有报告的不良事件.

科学领域:

细胞和分子医学细胞和分子医学
免疫学免疫学免疫学
再生医学是一种再生医学.

背景情况:

介酶体 stromal 细胞 (MSCs) 已被公认为在移植中的作用,提供免疫耐受性和减少对免疫抑制药物的依赖.
由带血 (CB) 衍生的MSCs由于其免疫学上的天真性和强大的抗炎和抗亡性质而特别有价值.

研究的目的:

建立适用于基于先进治疗药物 (ATMP) 的大规模临床试验的CB衍生MSC的库存.
详细介绍GMP认证的MSC的制造工艺和临床应用.

主要方法:

在一个符合良好制造实践 (GMP) 的系统中,MSCs被用塑料粘合剂分离出来.
建立了一家主细胞银行和一家工作细胞银行,生产经过认证的MSC (CB) 批次用于临床使用.
考虑了ATMP的监管框架,强调质量控制和安全.

主要成果:

一个明确的MSC制造工艺被证明是可行的.
263个GMP认证的MSC (CB) 制剂给了40名患有移植与宿主疾病,脏综合征或支气管肺功能障碍的受试者.
没有观察到输液相关的不良事件或等级毒性;报告了令人鼓舞的初步结果和临床反应.

结论:

十年的MSC (CB) 经验为我们提供了关于其用于免疫媒介疾病的宝贵见解.
符合GMP的制造使MSCs作为创新的基于细胞的治疗方法的临床应用成为可能.

关键词:

细胞治疗疗法细胞治疗疗法创新的治疗方法.介质细胞层层细胞.移植移植移植移植带血是指带血的血液.

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