Study Shows Advanced Heart Failure Patients Improve Significantly With Stem Cell Therapy

NEW YORK, June 6 /PRNewswire/ -- Patients with advanced heart failure
significantly improved after receiving stem cell therapy, according to results
of a small clinical trial presented as late-breaking news at the annual
meeting of the International Society for Minimally Invasive Cardiothoracic
Surgery (ISMICS). The study showed, 30 days after receiving the stem cells by
injection into their hearts, patients improved an average of 41 percent in
their hearts' pumping efficiency and the distance they could walk nonstop
increased by 72 percent in a standard test widely used to assess heart
patients. After 90 days, the heart-pumping improvements were sustained and
patients further improved the distance they could walk in the standard test,
by an additional 16 percent compared to 30 days and doubled compared to
baseline.
  The study is the first to use human fetal-derived stem cell therapy in
patients with heart failure. The surgical procedure was performed by Drs.
Federico Benetti(1), Luis Geffner(1), Yuliy Baltaytis(2) and Teodoro
Maldonado(3) at Luis Vernaza Hospital in Guayaquil, Ecuador. Advanced heart
failure is an incurable and usually fatal condition; other than heart
transplantation, current medical treatments cannot reverse the course of the
disease, and only slow its progression or help control its symptoms.
  "This is the first-ever study to use human fetal-derived stem cell therapy
in patients with heart failure and, though from a small group of patients, the
results are very compelling and demand additional research," said Valavanur
Subramanian, MD, Chairman of the Department of Cardiothoracic Surgery, Lenox
Hill Hospital, New York City and the study's senior investigator. "It was
especially gratifying to see these patients, many of whom couldn't walk more
than a short distance without losing their breath, improve their ability to
perform physical activities that are a part of everyday living," he said.

  Study and Findings
  In the study, 10 patients with advanced-stage heart failure underwent open
chest surgery during which human fetal-derived stem cells were injected into
their hearts. Before and 30 and 90 days after the procedure, patients were
assessed for the severity of their heart failure (stage 1-4), based on
standard New York Heart Association (NYHA) criteria; their hearts' "ejection
fraction," the portion of blood pumped out of a filled ventricle as a result
of a heartbeat and a measure of heart pumping efficiency, measured by
echocardiography; their performance on the standard "six-minute walk test," a
widely used clinical measure of functional capacity and endurance which
predicts mortality in patients with heart failure; and their performance on a
standard treadmill exercise tolerance test.
  One patient had to drop out of the study as she had a stroke 3 days after
the surgery and was unable to perform the 30-day follow-up tests, and another
non-compliant patient who failed follow-up was excluded from analysis.
  The study showed the eight analyzed study patients demonstrated
significant improvements at 30 and 90 days vs. baseline measures:
  -- An increase of 72.5 percent at 30 days and an additional 16.8 percent
  at 90 days in the distance completed while performing the six-minute
  walk test (275.0m to 553.8m)
  -- Treadmill exercise tolerance test increase from 2.5 METs at baseline to
  5.6 METs at 90 days (no 30-day follow-up was performed)
  -- 42.9 percent improvement in NYHA class (32.1 percent at 30 days and
  further 15.8 percent at 90 days, from 3.5 to 2.0)
  -- 41 percent increase in ejection fraction (26.6 percent to 37.5 percent
  at 30 days and sustained at 90 days)

  "These results suggest a potential for changing the trajectory of heart
failure," said Barnett Suskind, CEO of the Institute for Regenerative
Medicine, which provided the unrestricted grant for the study. "We are
committed to supporting and performing stem cell research to move to
therapeutic applications. We will follow these patients to obtain additional,
longer-term data, as well as perform variations of the procedure in new
patients as part of an extension of this study. In addition, we are currently
evaluating stem cell therapy in a variety of other disease conditions, and we
will begin additional studies in diabetes, neurological disorders, spinal cord
injuries and other conditions over the next year."
  This was the first reported study involving human fetal-derived stem cells
in heart failure patients. Researchers have reported on the use of adult stem
cells from the patients themselves (autologous) to treat heart failure. Fetal-
derived stem cells also have been used to treat other conditions, including
blood and immune system disorders, spinal cord injuries, stroke and other
neurological and eye disorders, and diabetes. Fetal-derived stem cells are
thought to be able to develop into a wider range of specialized cells than are
adult stem cells.
  The stem cells used in the study were provided by the Institute for
Regenerative Medicine and prepared from fetal tissues from legally consenting,
non-compensated donors outside the U.S. who underwent terminated ectopic
pregnancies, elective abortions or spontaneous miscarriages. Prior to use, the
cells were screened for viral, bacterial and fungal pathogens, similar to but
more rigorous than screening tests used for human blood and organs. Each
patient received 60-80 million cells.

  About Heart Failure
  Sometimes referred to as congestive heart failure, heart failure (HF) is a
complex clinical syndrome that can result from any structural or functional
heart disorder that impairs the ability of the heart's ventricle to fill with
or eject blood. In about two-thirds of patients, HF results from coronary
artery disease; the remainder have what is called non-ischemic cardiomyopathy,
the cause of which may be known (e.g., due to hypertension, valvular disease,
or heart infection) or unknown (e.g., idiopathic dilated cardiomyopathy). A
relatively common disorder, HF is estimated to affect nearly five million
people in the U.S., and each year accounts for approximately 550,000 new
patients and 970,000 hospitalizations, and directly causes 53,000 deaths and
contributes to 265,000 deaths.  The one-year mortality rate of patients in
NYHA Class 3 to 4 - the classification at baseline of patients in this study -
is nearly 40 percent.  The cost of medical treatment for HF has been projected
to be 27.9 billion dollars in the U.S. in 2005.
  Cardiac transplantation is currently the only established surgical
treatment for refractory end-stage HF, but it is available to fewer than 2,500
patients in the U.S. each year. Other standard treatments of HF are limited to
measures that only slow its progression or manage its symptoms, and include
various pharmacological therapies and surgical interventions.

  About the Institute for Regenerative Medicine
  Based in Barbados, the Institute for Regenerative Medicine (IRM) offers
stem cell treatment to patients with conditions ranging from diabetes and
heart disease to digestive diseases and nervous system disorders. Opened in
September 2004, IRM is one of the first facilities in the world to offer human
fetal-derived stem cell therapy. IRM medical professionals provide
individually tailored treatments based on a patient's medical history and
status, and will coordinate with a patient's physician to integrate treatment.
  IRM is dedicated to providing stem cell therapy for disease states
resulting from tissue damage and/or the effects of aging. IRM's stem cell
therapy is based on its novel research combined with findings from more than
30 years of clinical research and experience of the Institute for Problems of
Cryobiology and Cryomedicine, as well as other research documented in the
medical literature. Under the guidance of its scientific consulting board and
chief scientists, IRM is committed to developing new stem cell technologies
for the delivery of stem cell therapy for disease management.

  Footnotes
  (1.) From the Benetti Foundation, Rosario, Argentina.
  (2.) From the Institute for Regenerative Medicine, St. John, Barbados.
  (3.) From Luis Vernaza Hospital, Guayaquil, Ecuador.

SOURCE Institute for Regenerative Medicine

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