McKenna David H, Kadidlo Diane M, Miller Jeffrey S, Orchard Paul J, Wagner John E, McCullough Jeffrey
Division of Minnesota Molecular and Cellular Therapeutics Facility, University of Minnesota, Saint Paul, MN 55108, USA.
Transfus Med Rev. 2005 Jul;19(3):217-28. doi: 10.1016/j.tmrv.2005.02.007.
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.
基于分子、基因、细胞和组织的疗法已日益成为临床上可接受的治疗方式。监管要求和监督力度都有所增加，对适合生产此类疗法的设施的需求也变得更加明显。明尼苏达分子与细胞治疗设施是位于明尼苏达州圣保罗市明尼苏达大学的一个先进实验室，其设计目的是支持用于临床试验的生物制品的生产。一支在这类产品的研发、生产和管理的医学、科学、技术及监管方面经验丰富的优秀员工队伍，与该设施的特殊设计和建造相得益彰。造血干细胞（HSC）被用于移植操作，目前涉及新型疗法的临床试验包括使用异基因自然杀伤（NK）细胞和肿瘤疫苗治疗各种恶性肿瘤，以及使用自杀基因转导的T细胞预防骨髓移植后的移植物抗宿主病（GVHD）。其他疗法，包括骨髓来源的多能成人祖细胞（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，将用于治疗一系列疾病，且正处于不同的研发阶段。在此，我们对明尼苏达分子与细胞治疗（MMCT）设施进行概述，详细介绍我们生产新型疗法的方法，并重点介绍当前及未来的活动。
