Researchers to Study Adult Stem Cells in Patients With Heart Disease
CLEVELAND, OH November 10, 2005 -- Researchers at Case Western
Reserve University 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
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.
"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.
Source: DBusinessNews, Cleveland