Hey its phase II. Not really useful for us but progress.
http://www.ourmidland.com/prweb/article_155305c4-d5a1-5e2b-9783-f818dfd816c0.html
A new national study looking at the safety and effectiveness of
medication developed from adult stem cells for the treatment of ischemic
stroke has opened at University Hospitals (UH) Case Medical Center. The
Phase 2 study will use a cell therapy product called MultiStem®
developed by the Cleveland-based biotechnology company Athersys.
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 from a
patented class of early adult stem cells called Multipotent Adult
Progenitor Cells or MAPCs that are obtained from the 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.
Cathy Sila, M.D., principal investigator of the study,
Director of the Stroke and Cerebrovascular Center at UH Case Medical
Center, and Professor of Neurology at Case Western Reserve University,
said that the objectives of the study are to determine the highest
well-tolerated and safest single dose of MultiStem in patients with
ischemic stroke and to determine the efficacy of MultiStem on functional
outcome in ischemic stroke patients.
“Current therapy for stroke
is unfortunately very limited. There is only one drug, tPA, that is
approved for use in patients with acute ischemic stroke, and tPA needs
to be administered within hours of the onset of the stroke,” said Dr.
Sila. “Despite public education and the development of Stroke Centers,
only about 4 percent of all ischemic stroke patients presenting to the
hospital within 24 hours of their symptoms are eligible for tPA therapy.
We need to develop new drugs and biologic treatments to effectively
treat ischemic stroke and the damage resulting from the stroke in a
wider time window so more patients can be eligible for treatment.”
“Unlike
conventional drugs, we believe that MultiStem therapy provides benefit
in multiple ways when administered after an acute ischemic stroke,” said
Dr. Robert W. Mays, Head of Neuroscience at Athersys. “From our
preclinical work, 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 CNS injury, and we are very excited by the
potential of MultiStem therapy to treat stroke,” said Dr. Mays.
“We’re
trying to improve the functional outcome after a stroke,” said Dr.
Sila. If MultiStem therapy ultimately proves to be effective when given
at 24-36 hours after the stroke, it could mean that the majority of
stroke victims would be eligible for treatment.”
The national
study will involve approximately 25 sites with the goal of enrolling 140
patients. It will be double-blind (meaning both the patient and the
doctors evaluating the patients won’t know which arm of the study the
patient is in), randomized, placebo-controlled. The study is funded by
Athersys.
Athersys has advanced four MultiStem programs to
clinical stage, including for the treatment of acute myocardial
infarction, ischemic stroke, inflammatory bowel disease (partnered with
Pfizer Inc.), and to reduce the incidence of severe graft vs. host
disease following hematopoietic stem cell transplant.
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
Hope this thing gets approved. Well, I hope it works.
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