National Center For Regenerative Medicine Dedicates New Cell Production Facility That Will Advance Research From The Lab Into The Clinic
CLEVELAND, Nov. 21 /PRNewswire/ -- Case Western Reserve University, The Cleveland Clinic Foundation (CCF) and University Hospitals of Cleveland (UHC) -- founding partners in the National Center for Regenerative Medicine (NCRM) -- have doubled their capacity for moving adult stem cell research from the lab bench to the bedside for patient treatment with the opening of the new $2.1 million Cell Production Facility.
Funding for construction of the Cell Production Facility came from the Center for Stem Cell and Regenerative Medicine (CSCRM), a component member of the National Center for Regenerative Medicine. CSCRM has received $19.4 million from the State of Ohio's Wright Capital Fund and from the Biomedical Research and Technology Transfer Fund. The NCRM has received direct federal support of $4.5 million in efforts spearheaded by U.S. Rep. Ralph Regula (R-OH). A portion of this federal support assisted in the acquisition of equipment for the new facility.
Regula stated, "This new facility will increase the NCRM's ability to impact the lives of patients in need of the healing abilities of adult stem cell therapies. It is rewarding to see what can happen with the partnership of these three institutions, together with state and federal support."
The Cell Production Facility also is the first facility at Case, CCF or UHC open to researchers from all three institutions and available for use by commercial partners. Current commercial partners are Athersys, Inc., Arteriocyte, Inc., and RegenRx, Inc.
"Cleveland is a leader in adult stem cells and this state-of-the-art facility lets us make new discoveries in the treatment of patients with leukemia, anemia, congestive heart disease, and other terrible illnesses," said Stanton Gerson, M.D., the director of the NCRM and the Case Comprehensive Cancer Center and Ireland Cancer Center of University Hospitals of Cleveland.
The 3,000 sq. ft. production facility, located on the sixth floor of the Wolstein Research Building at Case, will allow Case, CCF and UHC researchers to conduct six experimental therapy patient clinical trials simultaneously. Previously, the three institutions could only accommodate half that capacity.
"This new production facility will provide Cleveland Clinic scientists and physicians with the ability to produce large numbers of adult stem cells for both clinical and laboratory-based experiments. There will be no need to reproduce the capabilities of this facility on our own campus in order to pursue our studies on regenerative medicine. It is an excellent use of State funds that will show great benefit to the region," said Paul E. DiCorleto, Ph.D., co-director of the NCRM and chairman of the Lerner Research Institute at the Cleveland Clinic.
The facility, which meets FDA guidelines for an early stage patient trials facility, is comprised of a suite of six clean culture rooms for the isolation, modification and expansion of adult stem cells for use in patient clinical trials. Each clean room has its own dedicated sterile hood for handling the cells, incubators, microscopes and other standard lab equipment. There is an outer laboratory space where the stem cells are carefully monitored and tested (quality control tested) to ensure they are the correct, functioning cells to be used in patients.
Up to 20 research associates and technicians, depending on the needs of the particular clinical trial, will work in the facility, which was designed by Hasenstab Architects Inc. of Akron, engineered by Karpinski Inc. of Cleveland and built by Erie Affiliates Inc.
The facility is currently being used for two clinical trials. The first is a gene therapy trial to protect the bone marrow of patients with advanced malignancies against the deleterious effects of chemotherapy. The second trial is testing a form of adult stem cells, mesenchymal stem cells (MSC), for their ability to reduce an immune reaction called graft versus host disease that sometimes occurs after bone marrow transplantation. Patients who received bone marrow transplants may experience some level of rejection in response to the donor's cells. Previous studies have shown the MSCs appear to be able to modulate this graft versus host response.
National Center for Regenerative MedicineCONTACT: George Stamatis of Case Western Reserve University, +1-216-368-3635, or george.stamatis@case.edu
Web site: http://www.cwru.edu/