This proposal requests continuing support for the General Clinical Research Center (GCRC) at the University of Michigan Medical Center (UMMC). The UMMC GCRC supports ethical investigations in any discipline in both children and adults and it is the only GCRC in the state of Michigan. This GCRC is absolutely essential to many federally funded research programs at our institution because it is the only facility at our Medical Center with inpatient beds dedicated to clinical investigation. Our GCRC also functions as the major site and resource within our institution for training in clinical investigation. The last grant award period has seen substantial growth in productivity of our Center, as measured by steady yearly increases in the numbers of investigators participating in clinical research protocols, in the total federal direct grant support for center investigators, and in the number of published manuscripts resulting from GCRC supported studies. We have also expanded our training programs, and should have our maximum allotment of funded CAPs and MCAPs(6)by year's end. We anticipate that demand for our GCRC resources will continue to increase for the forseeable future, fueled in part by the ongoing expansion of our Medical Center. This expansion will include opening the next two years of well over 200,000 square feet of incremental laboratory space and a new Cancer and Geriatric Center. In addition to requesting continued support for existing programs, we are requesting support for establishment of a new Human Genetics Studies Core within the GCRC. This core will provide to investigators interested in molecular medicine and gene therapy a series of vital services that would not otherwise be available. These services include coordination of the ethical recruitment of patients for GCRC protocols involving genetic analyses or gene therapy, and the life long monitoring of patients enrolled in gene therapy trials. We are also seeking additional support for our FDA approved Human Applications Laboratory (HAL) which is designed to produce gene transfer vectors and to culture human cells for gene therapy. Our current facility is no longer sufficient to meet our investigators' needs and the HAL will therefore undergo a $1.5 million expansion at its current location within the GCRC to be completed by Spring of 1995. The UMMC will pay all costs required for this expansion. We are requesting additional resources only for technical help or the HAL, and for costs associated with services we would like the expanded HAL to provide. Support for the Human Genetic Studies Core and for the expanded HAL is the subject of a supplemental application that has been submitted concurrently with this renewal application. Continued support for our GCRC and the new initiatives requested will assure optimal and cost effective progress by our investigators in many exciting areas of clinical investigation.
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