Miller School Doctors Conduct First-Of-Its-
Stem Cells to Treat Heart Failure
4/17/2008
In the continuation of a cutting-edge series of clinical trials
researching the use of stem cells to treat heart disease, Miller
School of Medicine physicians and scientists announced on Wednesday
that for the first time a patient underwent a procedure that could
hold the key to repairing damaged heart tissue, a potential life-
saver for the millions of people suffering from heart failure.
The study's leader, Joshua M. Hare, M.D., F.A.C.C., the Miller
School's chief of the Cardiovascular Division and director of the
Interdisciplinary Stem Cell Institute, said following the patient's
triple bypass surgery Monday, mesenchymal stem cells, or a placebo,
were injected directly in the patient's heart.
The stem cells are taken from the patient's bone marrow and cultured
at a UM laboratory. It is the first study funded by the National
Institutes of Health Specialized Center for Cell Therapy.
"The implication for this kind of therapy are enormous when you
consider that nearly five million Americans suffer from heart
failure, and 500,000 new cases are diagnosed each year," said
Hare. "We are very optimistic because we have experimental data that
show very clearly the cells we are using do have the ability to turn
into new heart muscle cells."
The groundbreaking Phase I/II clinical trial is a double-blind,
placebo-controlled study, where patients will be randomized to either
receive stem cells or the placebo.
"Everything went well and the patient is doing well," Si M. Pham,
M.D., surgical director of heart and lung transplantation, said of
Rodolfo Hernandez, the 56-year-old man who was given the injection
after bypass surgery at Jackson Memorial Hospital on Monday.
The Miami patient is the first of 45 people to participate in the NIH-
funded study being conducted at the UM Health System (UM Hospital and
affiliates, the Miami VA Medical Center and Jackson Memorial) and the
Johns Hopkins University. The enrolled participants will be divided
into three groups of 15 and one group will receive the placebo. Of
the remaining groups, one will receive a low-dose of their own
mesynchymal stem cells and the other, a high dose of the cells.
To qualify for the study, a patient must have had a heart attack that
resulted in damage to the heart and reduced pumping strength in the
left ventricle, the main pumping chamber of the heart, and be
undergoing heart bypass surgery.
Hare described Hernandez as a "typical individual who would benefit
from this kind of therapy."
"He had suffered a previous heart attack and required bypass surgery
for blocked vessels in his heart. This was an opportunity for us to
treat his scar, in addition to giving him new blood flow to his heart
to prevent the condition from getting worse," Hare said. "This is the
kind of patient who develops symptoms of congestive heart failure and
who also is at risk for a condition called cardiac sudden death where
people suddenly drop dead in the course of their daily activities
because of the scar in their heart."
There is much more follow-up to do but Hare envisions a bright future
where the groundbreaking procedure could, for some very ill patients,
negate the need for a heart transplant. "We really foresee the
possibility – again it is just a possibility and we have a lot of
work ahead of us –that we can replace injured heart tissue with
normal heart tissue and, if that turns out to be the case, then we
would be able to treat patients who would otherwise need a heart
transplant," Hare said.
A major goal of the study is to also develop a safety profile, look
at efficacy, and if successful, seek approval to move on to Phase
III, a much larger study. In the current phase, patients will be
followed for 18 months and will receive several examinations with a
sophisticated MRI scanner able to produce images that will show if
the injected cells resulted in the growth of new heart muscle.
At the April 16 news conference, Miller School Dean Pascal J.
Goldschmidt, M.D., praised Hare and his team and the strong
partnership between UM and Jackson. The Dean said rigorously
monitored stem cell research was being undertaken in various areas of
the Miller School, including at the Diabetes Research Institute, with
an eye to bringing more breakthrough therapies to patients.
"What Dr. Hare and his team have done is bring the work that was done
in laboratories to treat patients directly and that is phenomenal and
an extremely important step in the right direction," Goldschmidt
said. The research now "is in the area of heart failure and heart
disease but it's opening the doors for multiple other opportunities.
For this trial, under the direction of Ian McNiece, Ph.D., professor
of medicine and director of experimental and clinical cell-based
therapies at the Interdisciplinary Stem Cell Institute, the
mesenchymal cells were extracted from the patient's bone marrow,
purified and amplified.
In a previous multicenter study, Hare infused donor mesenchymal cells
into people who had recently had heart attacks. Those cells were
given intravenously and the trials showed the cell patients had lower
rates of side effects such as cardiac arrhythmias. They also showed
significantly improved heart, lung, and global function, compared
with patients not given the stem cells.
In the current heart failure study, Hare said lab tests have shown
that by injecting the cells directly in the injured area of the
heart, "they will stay in the injured area and work to heal the
injured area" by transforming into the kind of cells the patient
needs – such as new heart muscle cells.
Asked about risks, Hare said there is potential for inflammation and
heart muscle damage but the study has shown the cells interact
favorably with the immune system.
"One of the exciting things about this cell-based field, a lot of
times we anticipate risks and find the opposite, that a risk we were
worried about is actually treated by the cells."
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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