Date: Aug 14, 2009 Author: Deborah Miller Source: Cleveland.com (
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CLEVELAND -- George Reed, 73, still remembers the day his cardiologist told him there was nothing more he could do. Coronary bypass surgeries, stent procedures, defibrillators and pacemakers -- he'd been through it all.
A "no-option patient," the doctors called him. Another invasive procedure was out of the question. His heart, weakened by diffuse coronary artery disease, wouldn't be able to take it, his doctors said.
The Ashtabula policeman had one last hope: stem cell therapy.
The emerging field has long been hailed as the future of regenerative medicine. And over the past several years, the adult stem cell industry has quietly gained a strong foothold in the Northeast Ohio region.
STEM CELL COMPANIES IN NORTHEAST OHIO
Profile: Founded in Jan. 2004, developed stem cell technology to increase blood flow. Initial focus has been cardiovascular applications.
Clinical trials: 1 completed, 4 in various stages of implementation.
Venture capital funds raised/total grants received: $43 million.
Profile: Spun out of the Cleveland Clinic in July 2007, uses molecular factors that recruit stem cells and repair damaged areas after a heart attack.
Clinical trials: Anticipates starting its first clinical trial in 2010.
Venture capital funds raised: $8 million.
Total grants received: $1.8 million.
Cell Targeting Inc.
Profile: Incorporated in April 2005, uses molecular markers to direct cells.
Clinical trials: None.
Venture capital funds received: $1 million.
Total grants received: $1 million.
Invenio Therapeutics Inc.
Profile: Founded in June 2007, developing leukemia therapeutics.
Clinical trials: Initial trial anticipated in approximately 3 years.
Venture capital funds raised: $0.
Total grants received: $650,000.
Profile: Developing MultiStem, a stem cell product with the potential to reduce inflammation, protect damaged tissue and form new blood vessels.
Clinical trials: 2 ongoing, 1 anticipated.
Venture capital funds raised: $168.4 million.
Total grants received: $11.6 million.
The Center for Stem Cell and Regenerative Medicine was founded in 2003 with a $19.4 million award from the state of Ohio. Headquartered in a modest building on Case Western Reserve University's campus, the center is a "scientific matchmaker," bringing together researchers from CWRU, University Hospitals Case Medical Center, the Cleveland Clinic and Ohio State University, as well as area stem cell companies, to develop cell therapy treatments for a number of diseases.
Since its inception, CSCRM has received an additional $13 million from the state and spun out four for-profit, Cleveland-based start-ups: Arteriocyte Inc. in 2004, Cell Targeting Inc. in 2005 and Juventas Therapeutics Inc. and Invenio Therapeutics Inc. in 2007.
The four -- combined with biopharmaceutical company Athersys, one of the center's founding partners -- have raised over $235 million in venture capital and grant funding since the center opened.
Researchers at the center have conducted 51 clinical trials, treating over 250 patients with adult stem cells and over 60 patients with other cell therapies.
With little fanfare, Cleveland has become one of the leaders in the relatively young field of adult stem cell therapy.
"When we got started in 2003, stem cells were considered very esoteric and not very practical," says Debra Grega, Ph.D., CSCRM executive director. "Now that we've progressed into early stage clinical evaluations and actually are treating patients, we've gotten the attention of large pharmaceutical companies, which was absent until now."
As such therapies inch closer to receiving Food and Drug Administration approval, Grega and area stem cell company executives say Cleveland is competitive with research institutes in Boston and California.
CSCRM doesn't equal the Harvard Stem Cell Institute or the California Institute for Regenerative Medicine in size, Grega says, but the growth of the stem cell industry has the potential to transform Northeast Ohio's economy and boost the existing biomedical industry.
Top researchers and additional companies recruited to the region would develop new stem cell technologies and spin out companies, bringing in investment dollars and creating jobs, she says.
"We've been leaders in the country for adult stem cell [research] for 20 years -- that's where our strength has been," says Dr. Stanton Gerson, CSCRM director. "We're as good as anybody."
'A hidden gem'
What most people don't realize, Gerson says, is that Cleveland boasts a rich, though little publicized, history of adult stem cell research and development.
Cleveland scientists conducted the nation's first four adult stem cell clinical trials in 2003 and performed Ohio's first adult umbilical cord transplant in 1997, both at University Hospitals. The city is also home to the National Center for Regenerative Medicine, which was created in 2004 to translate laboratory research into clinical and commercial applications.
Though researchers and investors familiar with the adult stem cell industry recognize Cleveland as a national player, the area's prestige is not known outside that circle, and that may hamper recruitment efforts.
"Ultimately, you want to have a higher profile if you want to attract the highest level of talent," says Joe Wagner, the chief technical officer at Cell Targeting, Inc., which uses molecular markers to direct where cells go. "We need to make more of a presence. We've got a lot to be proud of here."
Wagner, along with other adult stem cell company leaders in the area, believe the industry will continue to grow organically in coming years. Investments from regional venture capital firms will drive the development of additional start-ups, they say. Once pharmaceutical companies enter the scene and partner with local stem cell companies, the burgeoning industry will see a spike in activity.
Pharmaceutical companies including Genzyme and Johnson & Johnson already have taken an interest in the stem cell industry and developed internal regenerative medicine platforms or departments within their companies, says Dr. Rahul Aras, Juventas Therapeutics president and CEO, who was recruited from New York roughly five years ago.
"As companies grow and as we continue to see more products, we'll be creating more jobs," Aras says. "It's already happening and will continue to happen. I'd like to think that it'll be an exponential process rather than linear."
To the region's credit, state and local governments recognized the stem cell industry's potential by providing financial support early on, company leaders say. The state has awarded Northeast Ohio over $32.4 million in research grants for adult stem cell research. The City of Beachwood recently purchased space that could potentially house a 7,000 square-foot "stem cell park" -- a corporate incubation center for start-up companies.
"Because of our region's strong presence in the biomedical field, we feel that Greater Cleveland has a leg up on developing stem cell technology," says Vince Adamus, CEO of Beachwood's Chamber of Commerce.
Despite the many resources in the Cleveland area, Cell Targeting's Wagner says that fighting the region's age-old reputation as "the old steel town in the Great Lakes with harsh winters" may prove to be a challenge.
"Cleveland's really got a lot going for it, but the nation isn't aware of it," Wagner said. "When I announced to my colleagues in Philly that I was moving to Cleveland, people mocked me for it."
"But it's a gem -- it's a hidden gem."
Therapy, then success
Almost a year after he started adult stem cell therapy treatment, George Reed still chokes back tears when he talks about his regained health -- made possible by the area's investment in research.
At his cardiologist's suggestion, he enrolled in a stem cell clinical trial at University Hospitals in downtown Cleveland. For a year, his doctors injected stem cells used to grow new blood vessels in areas of his heart that were not getting enough blood.
Reed's condition had progressively worsened to the point that he was forced to stop and catch his breath every few steps. Reed lived alone at the time. Simple household tasks left him exhausted. Picking up his mail was so laborious that he clambered into his pickup truck to drive to his mailbox.
After three months of the therapy, Reed noticed a significant improvement in his health. By the end of the clinical trial, he was able to walk two miles comfortably -- slowly, but always looking ahead, like Cleveland's adult stem cell industry.