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Senior Citizen Health & Medicine
Stem Cell Therapy Improves Heart, Lung Function in
Heart Attack Patients
Provacel significantly improved overall
condition at six months
 March 28, 2007 - Heart attack patients who received
a new intravenous adult stem cell therapy, Provacel, experienced a lower
number of adverse events, such as cardiac arrhythmias, and had
significant improvements in heart, lung and global function compared to
those who received a placebo, according to six-month Phase I study.
Among other findings, patients receiving Provacel
were 75 percent less likely to experience an arrhythmic adverse event
compared to those receiving placebo (9 % vs. 37%) and significantly more
patients who received Provacel experienced improvement in their overall
condition at six months as compared to those receiving placebo (42% vs.
11%).
Provacel is a preparation of adult stem cells
pre-formulated for intravenous delivery by the drug’s manufacture,
Osiris Therapeutics. Patients were administered an infusion of either
Provacel or placebo within 10 days of having a heart attack and are
being followed for 2 years. To prevent bias, neither the patient nor
the physician knows who received the stem cell treatment and who
received placebo.
The data was presented at the American College of
Cardiology’s Innovation in Intervention: i2Summit in New Orleans on
March 25. Ten cardiac centers across the country participated in the
53-patient, double-blind, placebo-controlled trial.
Principal investigator at Rush University Medical
Center cardiologist Dr. Gary Schaer, head of the Rush Cardiac
Catheterization Laboratory, says one reason the study results are so
promising is that these stem cells can be used without tissue typing and
do not trigger an immune response, and are available for every patient.
The mesenchymal stem cells (MSC) are found in the
adult bone marrow and have the potential to develop into mature heart
cells and new blood vessels. The MSC cells are derived from normal,
healthy adult volunteer bone marrow donors and are not derived from a
fetus, embryo or animal. Because they are in an early stage of
development, it is believed that they do not trigger an immune response
when placed in someone else’s body.
Similar to Blood Type O, these MSCs are being used
without tissue type matching to a specific patient.
A unique benefit of the stem cell product is that
it is given to patients through a standard IV line. Other therapies
require delivery to the site of the disease through catheterization or
open surgical procedures, but this one was very simple and easy for the
patient.
Schaer says the cells were grown in culture to very
high numbers, allowing a single donor's cells to treat thousands of
patients. “The cells have the ability to expand, or multiply, under
controlled conditions, and the expanded cells have the ability to
develop into different types of cells in the appropriate environment.
One donation can produce billions of MSCs. The cells can be stored for
years in a frozen state, ready to be used when they are needed.”
Adult stem cells are designed by nature to perform
tissue repair in a mature adult. It is believed that these cells can be
used in patients unrelated to the donor, without rejection, eliminating
the need for donor matching and recipient immune suppression. Once
transplanted, the cells promote healing of damaged or diseased tissues.
“Because of the participation by top tier sites
such as Rush University Medical Center, we were able to conduct a study
that was exceptionally well planned and executed” said C. Randal Mills
Ph.D., President and CEO of Osiris Therapeutics.
“We were confident in the safety profile given our
previous experience using the intravenous form of these stem cells to
treat other diseases in later stage clinical trials. However, we did
not expect to see the across-the-board clinical improvement observed in
patients at this early stage of testing.”
More about Provacel
Provacel™ is currently being evaluated
in clinical trials for the prevention of heart failure
resulting from acute myocardial infarction, or heart attack.
Provacel™ has been demonstrated in animal models to prevent
pathologic remodeling or scar formation in the area of the
heart. Animal studies have demonstrated the ability of the
product to return heart function to near normal levels in as
few as 2 months.
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About stem cells at the National Institutes of Health, click
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