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，操纵细胞的方法或设备，以促进细胞的某些结果，这些结果对许多疾病的新型细胞疗法的发展具有实际意义。虽然新疗法的潜力很大，但在精心设计的临床研究方案中已经进展到评估阶段的新细胞疗法的数量非常少。研究实验室必须专注于基本原理和有限的概念验证实验，而不是临床规模的活动，由于可用的资金来源和发现实验室的使命。基础研究人员需要额外的资源将验证的假设转化为临床应用。具体而言，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的设施。在目前的申请中，我们寻求这样一个资源的资金，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，以促进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。转化细胞治疗实验室将在任何给定的时间进行3-4个研究项目。这些项目将得到共享资源核心的支持，这些资源核心是根据最初的三个研究项目选择的。这些包括：流式细胞术资源核心，组织制造资源核心和开发资源核心。CHCT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，并在整个HMS中提高细胞治疗的知名度。 我们的目标是通过具有临床，技术和基础科学背景的个人的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.