Cleveland – The Ohio Third Frontier Commission unanimously awarded Case Western Reserve University’s National Center for Regenerative Medicine (NCRM), $2.4 million for its OH-Alive Innovator Platform: A Process and Manufacturing Platform for Cell Therapy. These funds must be matched by NCRM and its collaborators so this represents a total investment of $4.8 million. The OH-Aliveplatform will help advance Ohio as one of the leading regions for stem cell therapy in the country by establishing a facility that will provide expertise in determining optimized conditions for producing stem cells for therapeutic purposes. Ohio’s continued investment in cell therapy will be used to purchase state-of-the-art and customized equipment along with the formation of a team of skilled personnel tasked with intellectual property retention, regulatory submissions to the FDA, and commercial development for startups.
These services will be made available to basic researchers and biotechnology companies in Ohio and nationally who wish to translate their adult and pluripotent stem cell research from the bench to the patient in the pursuit of treating human disease and illness.
“This is the sixth award from the State of Ohio to NCRM, which, through its members, has received over $400,000 million in external funding since its inception in 2003,” said Stanton L. Gerson, MD, Director, Case Comprehensive Cancer Center and National Center for Regenerative Medicine, Case Western Reserve University School of Medicine. “This award brings together companies developing novel manufacturing systems to culture cells with NCRM investigators at Case Western Reserve University, the Cleveland Clinic Foundation and University Hospitals, who are developing cell therapy treatments for a wide variety of diseases. The center hopes this platform will accelerate movement of discoveries in the lab to clinical trials. There is no other facility like it in the country,” said Gerson.
Cell therapy is the medical application of living cell material used to provide novel, replacement cellular material to regenerate, restore, or rejuvenate the human body. In order for any cell therapy to be successful, cells must be expanded in culture under controlled conditions so that the environment mimics what they would see in our bodies. It is not straightforward to define the optimal culture conditions nor is it trivial to control what the cells will do. Yet, these technical barriers are being breached as we learn more about stem cell states and how cell differentiation is controlled.
”The OH-Alive platform establishment is an outstanding example of synergism between multiple institutions and commercial partnerships. Our assembly of the needed technologies and competencies was immediately recognized as valuable and many people, institutions and corporations joined the effort,” said Jan Jensen, PhD, Eddie J Brandon Chair of Diabetes Research at the Cleveland Clinic, and
Technical Director of OH-Alive. “We already have a strong local presence in future cell therapy in Cleveland, represented by the NCRM, leading national hospitals, and companies such as Athersys. OH-Alive will strengthen this further, extending our reach throughout the State collaborating with academic institutions and companies from Cincinnati to Cleveland.”
OH-Alive’s infrastructure for cell culture optimization and manufacturing will come from collaboration with BioSpherix’s Xvivo system which will provide a GMP-compliant space to work in and TECAN building customized robotic equipment for liquid handling to test specific culture conditions to grow and change the cells in.
“We were very proud to hear the National Academy of Sciences validate OH-Alive at the OTF commission meeting yesterday by stating that OH-Alive is unique in the United States. This review board representing scientific leadership in our nation also remarked that this platform represented the largest possible generator of company spin-off, product value enhancement, and ability to foster long-lasting economic impact for the State of Ohio, “says Michael Gilkey, MBA, MS, Director, OH-Alive and Marketing and Operations Manager, NCRM.
The grant was awarded to Case Western Reserve University in collaboration with Athersys, BioEnterprise, BioOhio, BioSpherix, Cleveland Clinic, TECAN, Renovo Neural, and NanoFiber Solutions.
The National Center for Regenerative Medicine, (NCRM) is a multi-institutional center composed of over 100 investigators from Case Western Reserve University, University Hospitals Case Medical Center, the Cleveland Clinic, Athersys, Inc., and The Ohio State University. Building on the 30-year history of adult stem cell research in northeast Ohio, NCRM was created in 2003 with a $19.4 million award from the Third Frontier Program. Since its inception, NCRM has effectively identified and developed appropriate stem cell therapeutics into clinical therapies and commercial biomedical opportunities. Visit www.ncrm.us/ncrm.
Founded in 1843, Case Western Reserve University School of Medicine is the largest medical research institution in Ohio and is among the nation's top medical schools for research funding from the National Institutes of Health. The School of Medicine is recognized throughout the international medical community for outstanding achievements in teaching. The School's innovative and pioneering Western Reserve2 curriculum interweaves four themes--research and scholarship, clinical mastery, leadership, and civic professionalism--to prepare students for the practice of evidence-based medicine in the rapidly changing health care environment of the 21st century. Nine Nobel Laureates have been affiliated with the School of Medicine.
Annually, the School of Medicine trains more than 800 MD and MD/PhD students and ranks in the top 25 among U.S. research-oriented medical schools as designated by U.S. News & World Report's "Guide to Graduate Education."
The School of Medicine is affiliated with University Hospitals Cleveland Medical Center, MetroHealth Medical Center, the Louis Stokes Cleveland Department of Veterans Affairs Medical Center, and the Cleveland Clinic, with which it established the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in 2002. case.edu/medicine.