Ohio's Center for Stem Cell and Regenerative Medicine said last week that it has received $5 million from the state's Third Frontier Commission to help it develop and eventually commercialize stem-cell inventions from its partner institutions.
The CSCRM will use the three-year grant, which was awarded under the Third Frontier's Research and Commercialization Program, to fund nine new research projects this year and at least eight in coming years, a CSCRM official said this week.
Each project will pair scientists from commercial entities in and out of state with CSCRM partners Case Western Reserve University, the Cleveland Clinic, University Hospitals, and private company Athersys. Ohio State University is also a CSCRM partner, but OSU researchers were not selected for funding under the latest award.
The state-based partners are expected to combine their resources to match each Third Frontier award, which will result in approximately $10 million for researching and developing stem-cell technology and regenerative medicine in Ohio, CSCRM said.
CSCRM's goal is to "rapidly translate cutting-edge stem cell and tissue engineering laboratory research into the clinic and commercial arenas to replace and repair diseased tissues and organs," according to its website.
To this end, it provides a "bench to bedside" approach to regenerative medicine, including programs for basic and clinical research, biomedical and tissue engineering, and for developing and administering new therapies. It supports some 40 core facilities located at CWRU, Cleveland Clinic, and the University Hospitals Case Medical Center campuses.
This is the third time the CSCRM has received cash from the state's Third Frontier program. The center launched in 2003 as a Wright Center of Innovation with a $19.4 million award from the state, which the center split evenly between buying capital equipment and supporting research projects. Its second state award, worth $8 million, came in 2006 from the Third Frontier's Biomedical Research and Commercialization Program.
Explaining Ohio's declining annual contribution to the program, Debra Grega, executive director of CSCRM, told BTW this week that "it's a state budgetary issue. If you look at economic trends in Ohio over the last 10 years, things have been decreasing, but the state has been preserving aspects of this program.
"The state legislature and leadership are looking for alternate ways of funding this," Grega added.
CSCRM will use the most recent grant to fund projects in three categories: commercial programs, emerging programs, and pilot programs. Commercial program projects are the most advanced from a commercial standpoint and "are expected to generate significant near-term value for sponsoring companies and Ohio," according to CSCRM.
Meantime, emerging programs have established proof of concept but need further refinement to advance toward potential commercialization; while pilot programs, which are considered very early-stage, are selected based on their significance to the field and their potential economic impact, CSCRM said.
The amount of funding for each commercial and emerging project will vary depending on its size and scope, Grega said. Pilot projects are to receive $50,000 per year over the course of three years, subject to satisfactory progress reports.
Each participating academic institution or corporate partner is expected to provide a cumulative one-to-one match on each funded project, though the percentage of each participant's contribution was not disclosed.
The following projects were selected for funding this year:
• Athersys, based in Cleveland, and Kenneth Cooke of UHCMC and CWRU, will further evaluate Athersys' adult stem-cell platform, MultiStem, for treating adverse immunological reactions triggered by cell-based cancer therapies. The project aims to advance the commercialization of MultiStem by running a Phase II clinical trial to evaluate the technology.
• Cleveland-based Juventas Therapeutics, a spin-out company founded by the Cleveland Clinic's Marc Penn, will develop its lead drug product, stromal cell derived factor 1, in a Phase I clinical trial for critical limb ischemia.
• Stan Gerson, director of CSCRM, is partnering with researchers from Lentigen, of Gaithersburg, Md., to develop a gene therapy approach to treating brain tumors.
• Jean Welter of CWRU and Adam Lambert of Oakwood Laboratories in Oakwood Village, Ohio, aim to develop a combination product comprising a drug and Oakwood's proprietary sustained-release technology to treat arthritic disease.
• Eben Alsberg of CWRU and Orthopediatrics of Warsaw, Ind., will use microspheres that release a specific amount of drug over a prolonged period of time to direct patients' cells to create cartilage.
• Bruce Trapp of Cleveland Clinic and Vertex Pharmaceuticals of Cambridge, Mass., will evaluate the potential of a cell from the adult human brain to treat a variety of neurodegenerative diseases and spinal cord injuries.
• Paul Tesar and Horst von Recum of CWRU will partner with the Cleveland Clinic's Jeremy Rich to establish a pluripotent stem-cell facility at CWRU and CC that will be the first of its kind in the state.
• Zhenghong Lee of UHCMC and Cleveland Clinic's Rich will develop a method to non-invasively image cancer stem cells using radiolabeled tracers.
• CWRU spinout Cell Targeting, based in Cleveland, 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.
Grega said negotiations dealing with intellectual property arising from the alliances are left up to the individual academic institution or research hospital as in sponsored research agreements.
"The IP rights reside with the investigator and their home institution," Grega said. "Those rights are worked out in research agreements between the company and academic institution. In general, the institution that has the greatest percentage effort in a project takes the lead, and often times industrial partners have a first right of refusal for licensing opportunities. That's all laid out by individual institution agreements."
Research teams interested in receiving funding are expected to submit a description of their project, its participating personnel, and top-line budget, Grega said.
Proposals are then reviewed by an executive committee comprising Grega, Gerson, Rich, and John Harrington, Athersys' executive vice president and chief scientific officer.
Initial recommendations by that committee are then reviewed by a research leadership council comprising eight CSCRM-affiliated senior investigators; as well as a commercialization council "that assesses it less on technical merit and more on its stage of development and commercial potential," Grega said.
"Generally there is a consensus," Grega added. "We know the dollar amount we can ask for from the state. Usually we have 70 to 80 percent agreement, and then we get the groups together to discuss the other 20 percent that we disagreed on."