Download A new study test the safety of adult stem cells for the treatment of

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Phone
Feb. 24, 2016
News Release
George Stamatis
216.844.3667
Department of Marketing and
Communications
3605 Warrensville Center Road
Cleveland, OH 44122
Stroke patients show higher rate of recovery from MultiStem® cell therapy studied
at University Hospitals Case Medical Center
Athersys reports data from stroke study at 2016 International Stroke Conference
CLEVELAND -- Data presented by the biotech company Athersys indicates that stroke
patients treated by an adult stem cell therapy called MultiStem® did significantly better
than others who received a placebo one year after treatment. The results are from a Phase
2 study involving clinical sites in the United States and the United Kingdom, including
University Hospitals Case Medical Center. The study examined the safety and
effectiveness of the new therapy developed for the treatment of ischemic stroke. The
data were presented Feb. 17 at the 2016 International Stroke Conference in Los Angeles.
Of the 65 patients treated with MultiStem®, 23.1 percent achieved a complete or near full
recovery from their stroke after one year. Only 8.2 percent of the 61 placebo patients
achieved that level of recovery. Patients who received the cell therapy within 36 hours
after the onset of stroke did even better, with 29 percent of those 31 patients achieving an
excellent outcome.
Cathy Sila, MD, Director of the Comprehensive Stroke Center at UH Case Medical
Center, and Professor of Neurology at Case Western Reserve University, was the
principal investigator of the study at UH Case Medical Center.
“These results are very promising and this therapy would be an important adjunct to acute
stroke care to reduce the amount of brain injury from which patients need to recover,”
said Dr. Sila. “But the results are still preliminary and need to be reproduced.”
Since MultiStem therapy seems to be effective when given at 24 to 36 hours after the
stroke, it means many more stroke victims would be eligible for treatment, she said.
“Current therapy for stroke is unfortunately very limited. There is only one drug, tPA,
that is FDA approved for acute ischemic stroke, and tPA needs to be administered within
hours of onset of a stroke,” said Dr. Sila. “Despite public education and the development
of stroke centers, only about 7 percent of all ischemic stroke patients nationwide receive
tPA therapy and less than 2 percent undergo catheter-based clot removal therapy. New
treatments are needed to reverse the effects of a stroke and promote recovery from stroke,
and they need to be effective in a wider time window to help more patients.”
Ischemic stroke is caused by blockage in an artery in or to the brain, that impedes blood
flow, and that can result in serious disability or even death.
MultiStem® is a proprietary medication made by the Cleveland-based biotech company
Athersys. The medication comes from a patented class of early adult stem cells called
Multipotent Adult Progenitor Cells or MAPCs that are obtained from bone marrow.
Hundreds of thousands to millions of doses can be made from the bone marrow cells of
one donor. The cells do not come from the patient, so can be made in advance, stored in
the hospital and be used off the shelf.
MultiStem® cells appear to reduce the local inflammatory response and protect neurons in
the brain, while modulating the body’s general immune response and inflammation which
leads to additional damage to the brain in the days immediately following the stroke. This
is an entirely new concept for how cell therapies may provide benefit following central
nervous system injury.
The Phase 2 study was double-blind (meaning both the patient and the doctors evaluating
the patients didn’t know which arm of the study the patient was in), randomized, and
placebo-controlled. The study was funded by Athersys.
A video with Dr. Sila and the first UH research participant in the MultiStem trial is
available at: http://www.youtube.com/watch?v=bRRTRa7ZEyY&feature=plcp
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About University Hospitals
Founded in May 1866, University Hospitals serves the needs of patients through an integrated network of
18 hospitals, more than 40 outpatient health centers and primary care physician offices in 15 counties
throughout Northeast Ohio. At the core of our $4 billion health system is University Hospitals Case
Medical Center, ranked among America’s best hospitals by U.S. News & World Report. The primary
affiliate of Case Western Reserve University School of Medicine, UH Case Medical Center is home to
some of the most prestigious clinical and research programs in the nation, including cancer, pediatrics,
women's health, orthopaedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive
health, transplantation and genetics. Its main campus includes UH Rainbow Babies & Children's Hospital,
ranked among the top children’s hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only
hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive
Cancer Center at Case Western Reserve University. UH is the second largest employer in Northeast Ohio
with 26,000 employees. For more information, go to www.UHhospitals.org.
About Athersys
Athersys is an international biotechnology company engaged in the discovery and development of
therapeutic product candidates designed to extend and enhance the quality of human life. The Company is
developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product,
initially for disease indications in the cardiovascular, neurological, inflammatory and immune disease
areas, and has several ongoing clinical trials evaluating this potential regenerative medicine product.
Athersys has forged strategic partnerships and collaborations with leading pharmaceutical and
biotechnology companies, as well as world-renowned research institutions to further develop its
platform and products. More information is available at www.athersys.com.