National Center for Regenerative Medicine dedicates new cell
production facility that will advance research from
the lab into the clinic
November 22, 2005
| For more information: George Stamatis 216-368-3635
 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.
The 3,000 sq. ft. production facility, located on the sixth floor of the
Wolstein Research Building, 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. 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.
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.
“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.
“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.
About the National Center for Regenerative Medicine
The National Center for Regenerative Medicine (NCRM) builds upon leading
research and clinical programs at its founding institutions—Case Western
Reserve University, The Cleveland Clinic Foundation, and University Hospitals
of Cleveland—in heart disease,
cancer, genetic disorders, and neurodegenerative diseases, coupled with a
25-year history of research on adult stem cells at these institutions. This
combination of outstanding clinical and research programs coupled with tested
and proven experience of using adult stem cell transplantation to treat patients
makes this center unique in the United States.
About The Cleveland Clinic Foundation
The Cleveland Clinic Foundation, located in Cleveland, Ohio, is a not-for-profit
multispecialty academic medical center that integrates clinical and hospital
care with research and education. The Cleveland Clinic was founded in 1921
by four renowned physicians with a vision of providing outstanding patient
care based upon the principles of cooperation, compassion and innovation.
U.S. News & World Report consistently
names The Cleveland Clinic as one of the nation’s best hospitals in
its annual “America's Best Hospitals” survey. Approximately 1,500
full-time salaried physicians at The Cleveland Clinic and Cleveland Clinic
Florida represent more than 100 medical specialties and subspecialties. In
2004, patients came for treatment from every state and 100 countries. The
Cleveland Clinic website address is www.clevelandclinic.org.
About University Hospitals of Cleveland
University Hospitals Health System (UHHS) is the region’s premier healthcare
delivery system, serving patients at more than 150 locations throughout northern
Ohio. Committed to advanced care and advanced caring, University Hospitals
Health System offers the region’s largest network of primary care physicians,
along with outpatient centers and hospitals. The System’s 947-bed, tertiary
medical center, University Hospitals of Cleveland (UHC), is an affiliate of
Case Western Reserve University. Together, they form the largest center for
biomedical research in the State of Ohio. Included in UHC are Rainbow Babies & Children’s
Hospital, among the nation’s best children’s hospitals; Ireland
Cancer Center, designated by the National Cancer Institute as a Comprehensive
Cancer Center (the nation’s highest designation); and MacDonald Women’s
Hospital, Ohio’s only hospital for women.
About Case Western Reserve University
Case is among the nation's leading research institutions. Founded in 1826
and shaped by the unique merger of the Case Institute of Technology and Western
Reserve University, Case is distinguished by its strengths in education, research,
service, and experiential learning. Located in Cleveland, Case offers nationally
recognized programs in the Arts and Sciences, Dental Medicine, Engineering,
Law, Management, Medicine, Nursing, and Social Work. http://www.case.edu.
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