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 i s to accomplish this goal by means of cross-fertilization of individuals with clinical, technical and basic science backgrounds.
