Feds give researchers OK for safety test of adult stem cells
in patients with heart disease
November 14, 2005
| For more information: George Stamatis 216-368-3635
Researchers at Case Western Reserve University School of Medicine and University
Hospitals of Cleveland announced today that the Food and Drug Administration
(FDA) has approved plans to begin a study to evaluate the safety of using
adult stem cells from bone marrow to treat chronic ischemia, a serious form
of heart disease.
The FDA has approved a Phase I study designed to test the safety of the
procedure. It will involve injecting bone marrow stem cells at varying doses
into the coronary arteries of patients suffering chronic ischemic coronary
artery disease, a condition in which one or more of the primary arteries supplying
blood flow to the heart are clogged. The study will include patients who are
not candidates for angioplasty, stent placement or coronary artery bypass
grafting (CABG).
Dale Adler, M.D., vice chair of medicine at Case and UHC, will lead this
study. The Harvard Clinical Research Institute (HCRI) has been contracted
to help run the trial and will establish an independent data and safety monitoring
board to ensure patient safety and data integrity.
“This is a first step in a long process to determine if this method
can someday be used to help patients with this heart condition,” said
Adler.
The trial is one of three ongoing studies in the United States to use bone
marrow stem cells to treat chronic ischemia. The procedure will include harvesting
stem cells from a patient’s bone marrow, capturing the stem cells, and
then infusing the stem cells through a coronary artery so that new blood vessels
will grow (neovasculogenesis). The hope is the new blood vessels will replace
or supplement those blood vessels that fail to adequately supply oxygenated
blood to heart tissue. The method was developed by Mary Laughlin, M.D., a
hematologist, and Vincent Pompili, M.D., a cardiologist, both of Case, UHC
and the National Center for Regenerative Medicine which has the mission of
bringing stem cell research from the laboratory into development for the treatment
of patients.
“Traditionally, physicians have been able to prevent heart attack
or alleviate its after-effects, but they have not figured out how to initiate
the sort of blood vessel repair that remains a key to survival,” says
Dr. Laughlin. “Now there is a promise of achieving that repair by infusing
highly selected marrow stem cells.”
Upon acceptance in the study, patients with blocked or damaged heart vessels
will be assigned to one of three groups, each made up of three to four patients
who will receive a preset dose of stem cell therapy. They will have stem cells
drawn from their own bone marrow. These cells will then be enriched in the
laboratory and injected into the patients at the site of their ischemia.
The Phase I study is being conducted at University Hospitals of Cleveland
with support from the National Institutes of Health, Case Western Reserve
University, and Cleveland-based Arteriocyte.
Blocked or damaged blood vessels are a major cause of illness and death
around the world. Atherosclerosis, for example, can lead to congestive heart
failure and heart attacks. About 5 million people in the United States have
heart failure and the number is growing. Each year, another 550,000 people
are diagnosed for the first time. It contributes to or causes about 300,000
deaths each year. About 1 percent of the U.S. population over the age of 65
is diagnosed with congestive heart failure each year. Existing therapies include
drugs, gene therapy, and vascular interventions for relief of arterial obstructions.
In 2003, approximately 750,000 coronary artery bypass graft (CABG) surgeries
were performed worldwide and approximately 1.8 million balloon angioplasty
procedures were performed. While these interventional therapies are now the
standard of care, there are still a significant number of people for whom
these methods do not work, or who have blockage throughout their bodies.
Arteriocyte is supporting this Phase I study through first installment of
a combined Phase I/II “fast track” Small Business Technology Transfer
Award grant from the National Heart, Lung, and Blood Institute (NHLBI). The
grant is part of an NIH program designed to help the transfer of innovative
technologies from an academic setting to the commercial sector and rapidly
translate research discoveries made in the laboratory into therapy for patients.
Arteriocyte was formed on the basis of the research of Drs. Laughlin and Pompili,
and a colleague Dr. Steven Haynesworth from Case’s College of Arts and
Sciences.
About Case Western Reserve University
Case is among the nation's leading research institutions. Founded in 1826
and shaped by the unique merger of the Case Institute of Technology and Western
Reserve University, Case is distinguished by its strengths in education, research,
service, and experiential learning. Located in Cleveland, Case offers nationally
recognized programs in the Arts and Sciences, Dental Medicine, Engineering,
Law, Management, Medicine, Nursing, and Social Work. http://www.case.edu.
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