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"This funding provides CSCRM the support it needs to continue to aggressively move new technologies from academic labs towards commercial development," said Stan Gerson, Director of the Center for Stem Cell & Regenerative Medicine. "We have linked corporate partners to our major projects and have been gratified by the development of a stem cell biotechnology commercial landscape in our region. Our goal is to rapidly move stem cell research from the lab to patients through clinical trials, using our strong background in preclinical models."

The continued research efforts will result in efficient clinical applications and commercialization of stem cells to benefit patients throughout Ohio. To date, such efforts have brought in $170 million in new commercial development and investment in Ohio.

"This grant continues to build distinctive and broad reach capabilities that are making Ohio a leader in the development and clinical use of cellular therapies," said Baiju R. Shah, President and CEO of BioEnterprise. "Ohioans benefit both through the resulting company development and jobs as well as by having access to leading-edge clinical therapies at our region's clinical institutions."

The use of stem cells has focused on leukemia and myeloma treatments with recent applications in cardiovascular disease. Current healthcare is limited to the use of drugs or devices to treat disease and injury. CSCRM, located in Northeast Ohio but collaborating state wide, is uniquely positioned to rapidly implement new stem cell technologies in the commercial and therapeutic arenas.

"I can see stem cells replacing drugs to improve many diseases," said Dr. Gerson. "Stem cells can replace injured cells, improve the function of many organs in the body and provide specific new functions to treat many diseases."

The Third Frontier funding will support the following commercial, emerging and pilot programs:

Commercial programs

The commercial projects are expected to generate significant near term value for the sponsoring companies and the State of Ohio.

• Athersys and Kenneth Cooke (UHCMC and CWRU) will further evaluate MultiStem(R) to cure immunological reactions to cell related therapies for cancer. The goal of this project is to advance the commercialization of MultiStem(R) cell therapy by running a FDA approved Phase II clinical trial to evaluate the performance of the cells.

• Juventas Therapeutics, spin out company from Marc Penn (CC), will develop its lead drug product, stromal cell derived factor 1 (SDF-1), through a Phase I clinical trial for critical limb ischemia.

Emerging programs

With further refinement of already established proof of concept, the following programs could mature into significant opportunities for CSCRM and the region.

• Dr. Gerson is partnering with Lentigen, Inc, of Gaithersburg, MD to develop a gene therapy approach to treating brain tumors.

• Jean Welter (CWRU) and Adam Lambert (Oakwood Laboratories) are teaming up to develop a combination product comprised of a drug and Oakwood's proprietary sustained release technology to treat arthritic disease.

• Eben Alsberg (CWRU) and Orthopediatrics of Warsaw, IN will use microspheres tuned to release a specific amount of drug over a prolonged period of time to tell the patient's cells to create cartilage.

• Bruce Trapp (CC) and Vertex Pharmaceuticals of Cambridge, MA have identified a cell in the adult human brain and will evaluate its potential to treat a variety of neurodegenerative diseases and spinal cord injury.

Pilot programs

The pilot projects represent early stage, cutting edge scientific projects that were developed in the Center. While these projects are at an early stage, they were selected based upon their significance to the field and their potential economic impact if successfully matured. Funding for the three projects will be accompanied by a subset of eight new pilot projects determined through review by CSCRM oversight committees.

• Paul Tesar (CWRU), Horst von Recum (CWRU) and Jeremy Rich (CC) will establish a Pluripotent Stem Cell Facility within CWRU and CC which will be the first of its kind in the State of Ohio. 

• Cell Targeting will apply its cell "painting" technology to direct umbilical cord blood stem cells to specific locations in the body to increase cell dosage and improve engraftment.

• Zhenghong Lee (UHCMC) and Jeremy Rich (CC) will collaborate to develop a method to non-invasively image cancer stem cells through the development of radiolabeled tracers.

The CSCRM Administration, led by Debra Grega and Michael Gilkey, is responsible for coordinating, accounting and reporting on all of these projects, continuing and creating education programs on stem cells and regenerative medicine for middle school through graduate level students, executing a biennial international stem cell conference (MSC 2009), interfacing and cultivating new commercial interactions, developing new research collaborations within the State as well as internationally, and representing the Center in scientific conferences and public events.

About the Center for Stem Cell & Regenerative Medicine

The Center for Stem Cell and Regenerative Medicine 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 Ohio State University. Building on the 30 year history of adult stem cell research in northeast Ohio, the Center was created in 2003 with a $19.4 million award from the State of Ohio as a Wright Center of Innovation. An additional $8 million award in 2006 from the State of Ohio's Biomedical Research and Commercialization Program further validated the Center's ability to achieve its mission to utilize human stem cell and tissue engineering technologies to treat human disease. In 2009, $5 million was awarded by the Ohio Third Frontier Program to continue the commercialization of new stem cell and related technologies. Since its inception, CSCRM has effectively identified and developed appropriate stem cell therapeutics into clinical therapies and commercial biomedical opportunities based on preclinical work at Case Western Reserve University and the Cleveland Clinic; clinical validation studies at University Hospitals and Cleveland Clinic; commercial translation of new technologies by Oakwood Laboratories, Orthopediatrics and Cell Targeting; and new commercially sponsored clinical trials in Ohio by Athersys and Juventas Therapeutics. http://www.thestemcellcenter.org.

About Case Western Reserve University School of Medicine

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. Eleven Nobel Laureates have been affiliated with the school.

Annually, the School of Medicine trains more than 770 M.D. and M.D./Ph.D. students and ranks in the top 25 among U.S. research-oriented medical schools as designated by U.S. News and World Report "Guide to Graduate Education."

The School of Medicine's primary affiliate is University Hospitals Case Medical Center and is additionally affiliated with 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. http://casemed.case.edu.

SOURCE Case Western Reserve University