By Deborah Brown | The Saginaw News
April 18, 2010, 6:30AM

SAGINAW — A research study for stem cell therapy in heart attack
patients is breaking new ground in the Great Lakes Bay Region.
A Phase II clinical trial, conducted by the Michigan Stem &
Regenerative Medicine Program of the Michigan CardioVascular
Institute and Covenant Health Care, is evaluating stem cell therapy
with its goal of reducing inflammation and promoting regeneration.
Dr. Safwan Kassas, an interventional cardiologist with MCVI, has
successfully infused two patients, William C. Smith, 60, of Bay City, in
December, and Brenda Sigmund, 62, of Caro, in January.
“Stem cells represent a promising cardiac research avenue, given their
potential to preserve heart function in at-risk patients,” Kassas said.
“Cardiologists today are unable to reverse cardiac deterioration
following a severe heart attack.”
 

Kathleen Mostek, director of research and regenerative medicine for
MCVI, 1015 S. Washington in Saginaw, said the stem cells were taken
from five volunteers, grown in a lab and stored in a bank in a freezer.
“This protocol is adult stem cells, they are the same for everyone in
the world, with no rejection,” Mostek said.
The Prochymal investigational therapy was developed by Osiris
Therapeutics Inc., of Columbia, Md., and contains mesenchymal stem
cells taken from the bone marrow of healthy, screened adult volunteer
donors, Mostek said.
 

Studies have shown this formulation to be universally compatible,
similar to type O blood, the universal donor.
“If stem cells can effectively prevent or repair heart muscle damage,
there is potential to meaningfully reduce long-term complications such
as repeat heart attacks and heart failure,” Kassas said.
The stems cells are delivered intravenously in combination with
standard care.
 

“They are designed to provide therapeutic benefit by controlling
inflammation, promoting tissue regeneration and preventing scar
formation,” Mostek said.
 

The double-blind, placedo-controlled stem cell study is being
conducted in the U.S. and Canada and will enroll about 220 patients.
To be eligible for the trial, patients must have experienced their first
heart attack within seven days.
 

A heart attack occurs when blood flow is suddenly and completely
blocked. Phase I of the trial involved 53 patients and found adverse
effects were lowered, with improved heart function and irregular
heartbeat reduced when comparing patients treated with Prochymal to
the placebo group, Mostek said.
 

The American Heart Association states 18 percent of men and 35
percent of women will have a repeat heart attack within six years of a
recognized heart attack, significantly weakening heart muscle.
Infused patients are closely monitored with follow-ups occurring every
three months, Mostek said.
 

“The results won’t be complete until the last patient has completed
their last visit,” she added, “about two-and-a-half to three years.&rdquo
In addition to this cardiac research study, Prochymal has been the
subject of Phase III clinical trials for acute and steroid-refractory graft
versus host disease, or a rejection by the body’s immune system, and
also for Crohn’s disease.