CENTER FOR HUMAN CELL THERAPY

描述(由申请人提供)： 近年来，许多基础科学实验室已经确定了细胞的特征、操纵细胞的方法或装置，以促进细胞的某些结果，这对开发基于细胞的治疗许多疾病的新方法具有实际意义。尽管新疗法的潜力很大，但已经进入设计良好的临床研究方案评估阶段的基于细胞的新疗法的数量非常少。由于现有的资金来源和发现实验室的使命，研究实验室必须专注于基本原则和有限的概念验证实验，而不是临床规模的活动。基础研究人员需要额外的资源来将经过验证的假说转化为临床应用。具体地说，需要通过提供放大实验、高端细胞选择和培养、生物装置和GMP条件下的细胞处理、SOP开发、IND开发和临床试验开发来完成向临床实践的过渡。在目前的申请中，我们为这样一个资源寻求资金，即人类细胞治疗中心(CHCT)。该中心将作为哈佛医学院(HMS)及其附属机构不同部门的独特资源，促进针对各种人类疾病的新细胞疗法的开发。 CHCT的三个主要组成部分包括转化细胞治疗实验室、共享资源核心和教育/培训计划。翻译细胞治疗实验室在任何时候都会进行3-4个研究项目。这些项目将得到共享资源核心的支持，这些核心是根据最初的三个研究项目选定的。这些资源包括：流式细胞仪资源核心、组织制造资源核心和发展资源核心。CHCT的教育/培训计划的目标是培养年轻医生/科学家对细胞治疗相关领域的兴趣，并使细胞治疗在整个HMS中更受关注。我们的目标是通过具有临床、技术和基础科学背景的个人进行交叉受精来实现这一目标。

DESCRIPTION (provided by applicant): In recent years, numerous basic science laboratories have identified characteristics of cells, methods of manipulating cells, or devices to facilitate certain outcomes from cells that have practical implications for the development of novel cell-based therapies for many diseases. Although the potential for new therapies is great, the number of new cell based therapies that have progressed to the stage of assessment in a well designed clinical research protocol is very small. Research laboratories are necessarily focused on basic principles and limited proof-of-concept experiments rather than clinical scale activities due to the funding sources available and the mission of a discovery laboratory. Additional resources are needed for basic investigators to transform validated hypotheses into clinical applications. Specifically facilities are needed where the transition to clinical practice can be accomplished by providing scale-up experimentation, high-end cell selection and culturing, bio-device and cell handling under GMP conditions, SOP development, IND development and clinical trial development. In the current application, we seek funding for such a resource, namely the Center for Human Cell Therapy (CHCT). This Center will serve as a unique resource across different departments at Harvard Medical School (HMS) and its affiliated institutions to facilitate the development of new cell therapy for a variety of human diseases. The three principal components of the CHCT include the Translational Cell Therapy Laboratory, Shared Resource Cores and an Educational/Training Program. The Translational Cell Therapy Laboratory will conduct 3-4 research projects at any given time. These projects will be supported by the Shared Resource Cores, which have been selected based on the initial three research projects. These include: Flow Cytometry Resource Core, Tissue Manufacture Resource Core and a Development Resource Core. The goal of the Educational/Training Program of the CHCT is to foster interest of young physicians/scientists in areas relevant to cellular therapy and give cellular therapy more visibility throughout HMS. Our aim is to accomplish this goal by means of cross-fertilization of individuals with clinical, technical and basic science backgrounds.