Molecular-, gene-, cellular-, and tissue-based therapies have become increasingly acceptable modes of clinical therapy. Regulatory requirements and oversight have increased, and the need for facilities suited for production of such therapies has become more apparent. The Minnesota Molecular and Cellular Therapeutics Facility is a state-of-the-art laboratory at the University of Minnesota, Saint Paul, Minn, that was designed to support production of biologic products for use in clinical trials. A talented staff experienced in the medical, scientific, technical, and regulatory aspects of the development, production, and administration of such products complements the special design and construction of the facility. Hematopoietic stem cells (HSCs) are manipulated for transplant, and current clinical trials involving novel therapies include the use of allogeneic natural killer (NK) cells and tumor vaccines for the treatment of various malignancies and suicide gene-transduced T cells for the prevention of graft-vs-host disease (GVHD) after bone marrow transplantation. Other therapies, including marrow-derived multipotent adult progenitor cells (MAPCs), umbilical cord blood (UCB) stem cells, regulatory T cells, skeletal myoblasts, and monoclonal antibodies, will be used to treat a spectrum of disease and are in various phases of development. Here we provide an overview of the Minnesota Molecular and Cellular Therapeutics (MMCT) Facility, detailing our approach to the manufacture of novel therapeutics and highlighting current and future activities.

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明尼苏达州分子和细胞治疗学设施：一个先进的生物治疗工程实验室。

基于分子，基因，细胞和组织的疗法已成为临床治疗日益被接受的模式。监管要求和监督已经增加，并且对于适合于生产这种疗法的设施的需求变得更加明显。明尼苏达州分子和细胞治疗设施是位于明尼苏达州圣保罗的明尼苏达大学的最先进实验室，旨在支持生产用于临床试验的生物制品。在此类产品的开发，生产和管理的医疗，科学，技术和法规方面具有丰富经验的优秀人才可以补充设施的特殊设计和建造。造血干细胞（HSC）被操纵用于移植，当前涉及新疗法的临床试验包括使用同种异体自然杀伤（NK）细胞和肿瘤疫苗来治疗各种恶性肿瘤，以及通过自杀基因转导的T细胞来预防骨髓移植后的宿主对宿主疾病（GVHD）移植。其他疗法，包括骨髓源性多能成年祖细胞（MAPC），脐带血（UCB）干细胞，调节性T细胞，骨骼肌成肌细胞和单克隆抗体，将被用于治疗多种疾病，并且处于不同阶段发展。在这里，我们提供了明尼苏达州分子和细胞疗法（MMCT）设施的概述，详细介绍了我们生产新型疗法的方法，并着重介绍了当前和未来的活动。