Cytori (NASDAQ:CYTX) completed enrollment in the first study to
investigate adipose derived stem and regenerative cells in chronic heart
disease. The trial, which has been named the PRECISE study, was carried
out at leading cardiology centers in Europe. It specifically enrolled
patients suffering from an advanced form of chronic heart disease, known
as chronic myocardial ischemia, for which there is no generally accepted
treatment.
The trial enrolled 27 patients and was designed as a double-blind,
randomized, placebo controlled, dose escalation study. It is unique in
that the patients’ own cells were extracted from adipose tissue and
processed for delivery at the point of care using Cytori’s Celution®
System. The cells were then injected back into the patients using the
NOGA® XP System (Biologics Delivery Systems, Cordis Corp., a Johnson and
Johnson company), which identifies and guides cells to damaged regions
of the heart.
The primary objectives of the study were to assess safety and
feasibility of Cytori’s Celution® System as part of a novel procedure
for chronic heart disease. The Company believes it will be able to fully
assess these primary objectives with the data obtained from 27 patients
(the protocol allowed for up to 36 patients). Further, the independent
data safety and monitoring board had not identified any safety concerns
relating to the Celution® output or the procedure. Six month results are
expected in the first half of 2010.
“This represents a significant development in the field of cardiac cell
therapy,” said Emerson Perin, M.D., Director of the New Interventional
Cardiovascular Technology and Director of the Stem Cell Center at the
Texas Heart Institute and co-principal investigator for PRECISE. “Should
the Celution® System output prove efficacious in this patient
population, this novel treatment could constitute a completely new
approach in obtaining stem cells that may be of therapeutic benefit to
the heart.”
“The advantage to Cytori’s approach to cardiac cell therapy is that the
Celution® System is the only technology that prepares a patient’s own
cells at the point of care during a single surgical procedure,” added
Professor Francisco Fernandez-Avilés, Professor of Medicine and Chair of
the Department of Cardiology at Hospital General Universitario Gregorio
Marañón and co-principal investigator. “A major attribute of the
Celution® output is that it is comprised of multiple cells types.
