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用于 I 期临床试验的间充质基质细胞的制造。

Manufacturing mesenchymal stromal cells for phase I clinical trials.

机构信息

Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and The Methodist Hospital, Houston, TX, USA.

出版信息

Cytotherapy. 2013 Apr;15(4):416-22. doi: 10.1016/j.jcyt.2012.09.007.

Abstract

Mesenchymal stromal cells (MSCs) are multipotent progenitor cells capable of differentiating into adipocytes, osteoblasts and chondroblasts as well as secreting a vast array of soluble mediators. This potentially makes MSCs important mediators of a variety of therapeutic applications. They are actively under evaluation for immunomodulatory purposes such as graft-versus-host disease and Crohn's disease as well as regenerative applications such as stroke and congestive heart failure. We report our method of generating clinical-grade MSCs together with suggestions gathered from manufacturing experience in our Good Manufacturing Practices facility.

摘要

间充质基质细胞(MSCs)是多能祖细胞,能够分化为脂肪细胞、成骨细胞和软骨细胞,以及分泌大量可溶性介质。这使得 MSCs 成为多种治疗应用的重要介质。它们正在积极评估免疫调节用途,如移植物抗宿主病和克罗恩病,以及再生应用,如中风和充血性心力衰竭。我们报告了我们生成临床级 MSCs 的方法,并从我们的良好生产规范设施的制造经验中收集了建议。

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