Our beginning
The National Center for Regenerative Medicine began as The Center for Stem Cell and Regenerative Medicine--a multi-institutional center comprised of investigators from Case Western Reserve University (CWRU), University Hospitals, the Cleveland Clinic, Athersys, Inc., and The Ohio State University. The creation of The Center followed the 30 year success of stem cell research in Northeast Ohio. Following the receipt of a Wright Center of Innovation grant in 2003, the National Center for Regenerative Medicine (NCRM) was officially launched on Case Western Reserve University's campus in 2004.
Funding our expansion
An additional $8 million was awarded in 2006 from the State of Ohio’s Biomedical Research and Commercialization Program—and, in June 2009, a $5 million award from Ohio’s Third Frontier Commission further validated NCRM’s ability to achieve its mission to utilize human stem cell and tissue engineering technologies to treat human disease. Subsequent projects supported spin-off companies such as Trailhead Biosystems and the Cleveland Cord Blood Center. Arnold Caplan’s discoveries in Mesenchymal Stem Cells benefited the NCRM immensely and led to the creation of several Cleveland area biotechnology companies.
Senator George Voinovich, with strong support of Ohio Congressman Ralph Regula, provided over $7.7M to the National Center for Regenerative Medicine in April 2007. A visit from Voinovich and Regula resulted in the construction of the Lerner Research Institute Department of Stem Cell Biology, the research cell therapy patient beds in the new Seidman Cancer Center, and the cell production facility in the Wolstein Research Building. A record of Senator Voinovich’s speech can be found in the Congressional Record, April 7, 2007, S4350-S4351.
Building on our successes
From its inception, the National Center for Regenerative Medicine (NCRM) has represented a new paradigm in biomedical research and therapy. Rather than relying solely on drugs or devices to manage disease, regenerative medicine focuses on using stem cells to repair and regenerate damaged tissues and organs. NCRM was founded to advance this approach through a comprehensive and coordinated “bench-to-bedside” model, integrating basic and clinical research with biomedical and tissue engineering programs; and to translate discoveries into therapies for patients.
Building on the exceptional track records of its investigators in stem cell science, tissue engineering, and early “first-in-the-nation” stem cell clinical trials, NCRM has long promoted research that moves efficiently from the laboratory to clinical and commercial application. Its work has been anchored in areas of established excellence at its affiliated institutions, including heart disease, adult stem cell transplantation, cancer, genetic disorders, and musculoskeletal and neurodegenerative diseases such as multiple sclerosis.
A defining milestone in NCRM’s early history was the launch of the world’s first five clinical trials using mesenchymal stem cells, led by investigators Hillard Lazarus, Omer Koc, and Jeffrey Cohen. These foundational efforts continue to shape NCRM’s mission today, as the center remains committed to advancing regenerative therapies that improve patient care and transform medicine.
Strategic partnerships
NCRM continues to advance research on mesenchymal stem cells (MSCs), which can support healing by reducing inflammation, fighting infection, and helping the body repair damaged tissue. Building upon the work of stem cell pioneer Dr. Arnold Caplan, the Bonfield Lab is developing MSC-based therapies for conditions such as steroid-resistant asthma and cystic fibrosis (CF).
This work led to the first-ever Phase I clinical trial using MSCs in people with CF at UH Rainbow Babies & Children’s Hospital. The trial showed the therapy was safe and has sparked broader collaborations across the CF research community. Building on this progress, NCRM and Dr. Tracey Bonfield are now preparing for a Phase II, multi-center global clinical trial focused on lung infections in CF patients.
NCRM also partners with UH, MetroHealth, and Cleveland Clinic to improve how MSC therapies are tested, manufactured, and delivered to patients. Beyond disease treatment, MSCs are being explored for their ability to help build and repair tissue, including through a large, multi-institutional research effort at CWRU focused on musculoskeletal regeneration.
The Cleveland Clinic is a key partner of the National Center for Regenerative Medicine (NCRM), collaborating on a wide range of research and clinical initiatives. In 2020, Dr. Timothy Chan came to Cleveland and founded the Global Center for Immunotherapy and Precision Immuno-Oncology (CITI), which works closely with NCRM to develop new CAR-T therapies and improve how these treatments are made.
Leading this effort, Dr. Jan Joseph Melenhorst has created next-generation CAR-T therapies targeting B7H3 and other cancer markers, with a new clinical trial now getting underway. Cleveland Clinic researchers have also partnered with NCRM on multiple clinical trials using mesenchymal stem cells to treat inflammatory diseases.
In addition, Dr. Chan’s team has built advanced immune-monitoring and genomics tools to support NCRM studies and strengthen trial data. Together, Dr. Chan and Dr. Melenhorst are expanding specialized manufacturing space for NCRM researchers, including new facilities for vaccines and nanoparticle-based therapies, with construction beginning in early 2025.
Since 2022, MetroHealth System has played a major role in advancing the National Center for Regenerative Medicine (NCRM), highlighted by the launch of a state-of-the-art manufacturing facility—the first in Northeast Ohio capable of producing gene and cell therapies. Led by Dr. William Tse, this program works closely with biotechnology partners to develop and deliver next-generation cellular treatments.
MetroHealth researchers have pioneered first-in-human therapies, including innovative CAR-T cells for rare blood cancers and engineered immune cells designed to better attack solid tumors. The team also develops improved gene-delivery tools to make these therapies stronger, longer-lasting, and more effective for patients.
Through its leadership in clinical trials, advanced manufacturing, and collaborative research; including gene and mesenchymal stem cell therapies. MetroHealth has become a vital resource for NCRM investigators. These efforts strengthen NCRM’s regional and national leadership in immune-oncology and regenerative medicine, helping bring promising discoveries from the lab to the clinic.