ROME, Aug. 28, 2016 /PRNewswire/ -- EUROPEAN SOCIETY OF
CARDIOLOGY CONGRESS 2016 -- Study sponsor CardioCell LLC, a global
biotechnology company that uses allogeneic stem cells for
cardiovascular indications, announces data from its pre-clinical
study "Mesenchymal stem cells grown under chronic hypoxia improve
LV function and inhibit adverse remodeling in mice with chronic
ischemic cardiomyopathy" at a European Society of Cardiology (ESC)
Congress Poster Session. Co-Author Dr. Michael Lipinski, Interventional Cardiologist
at MedStar Washington Hospital Center, presents the study that was
designed in collaboration with Drs. Dror
Luger, Research Scientist at Washington Hospital Center and
Stephen Epstein, Director, Translational and Vascular Biology
Research at MedStar Heart and Vascular Institute, Chair of
CardioCell's Scientific Advisory Board and Member of CardioCell's
Heart Failure Advisory Board.
Pre-clinical results using a murine model prove the validity of
the hypothesis that intravenous (IV) injection of CardioCell's
ischemia-tolerant mesenchymal stem cells (itMSCs) exert beneficial
effects on cardiac function in ischemic cardiomyopathy. The results
suggest that excessive inflammation is an important cause of the
progressive cardiac dysfunction seen in the control group and that
itMSCs exert beneficial cardiac effects — at least, in part — by
their systemic anti-inflammatory effects.
"I believe this study could have transformational effects on the
treatment of heart failure (HF)," says Dr. Stephen Epstein, Director, Translational and
Vascular Biology Research at MedStar Heart and Vascular Institute.
"HF patients will almost certainly not be cured by a single
injection of stem cells. This demonstration that IV administration
of itMSCs grown under chronic hypoxia improves cardiac dysfunction
in HF suggests that IV itMSC administration will be an effective
and safe strategy for providing the repeated treatments that will
probably be necessary in patients with ischemic
cardiomyopathy."
Here is a summary of the methodology and results:
- Methodology: CD1 male mice underwent acute myocardial
infarction with 45 minutes of left anterior descending artery
ischemia. Echocardiography was performed 4 weeks later (considered
the "baseline" study) and animals were randomized into 2 groups
based on left ventricular ejection fraction (LVEF) to ensure even
distribution of LVEF between the groups. Mice then received either
control saline tail-vein injection (n=16) or injection of
2x106 human itMSCs grown chronically at 5% O2 (n=16).
Echocardiography was repeated 1 week and 3 weeks following
injection. Data are presented as Mean ± SEM.
- Results: At baseline, there were no differences between
the groups in regards to any echocardiographic parameters. However,
mice that received a single itMSC IV injection demonstrated a
significant improvement in LVEF at 1 week and had progressive
improvement in LVEF at 3 weeks. The itMSC group demonstrated no
change in LV end diastolic volume at 3 weeks; in marked contrast,
the control group demonstrated an increase in LV end diastolic
volume. Importantly, mice that received itMSC injection
demonstrated a significant reduction in LV end systolic volume and
a significant increase in LVEF. These improvements in LV function
were associated with immunomodulatory effects: Flow cytometry
demonstrated that IV itMSC treatment significantly reduced both
splenic neutrophils (5.6±1.9% vs. 9.9±2.5% for control,
p<0.0001) and immature myeloid cells (2.6±0.7 vs. 4.9±1.3 for
control, p<0.0001). The increase in lymphocyte populations
correlated with improvements in LV dimensions and function.
- Authors: Michael J.
Lipinski, Dror Luger,
Peter C. Westman, Sergey Sikora, Ron
Waksman and Stephen E.
Epstein.
The hypothesis of this study was designed to determine whether
systemic effects of IV itMSC delivery improves myocardial
function. It was previously thought that large numbers of stem
cells must be delivered to the myocardium to exert beneficial
effects on the heart. The study results show that IV itMSC
injection significantly improves LV function and adverse LV
remodeling in mice with chronic ischemic cardiomyopathy. The
beneficial effects on LV function were associated with
itMSC-induced anti-inflammatory effects.
Only CardioCell's chronic HF therapies feature itMSCs, which are
exclusively licensed from CardioCell's parent company Stemedica.
Unlike MSCs grown under normoxic conditions, Stemedica's
bone-marrow-derived, allogeneic itMSCs are grown under hypoxic
conditions. In vivo experiments demonstrate cells that are
exposed to hypoxic conditions show greater homing and engraftment
than cells grown under normoxic conditions. Compared to MSCs
manufactured under normal oxygen condition, itMSCs secrete higher
levels of growth factors and other important proteins associated
with neoangiogenesis and healing.
About CardioCell LLC
Founded in San Diego, California, in 2013, CardioCell LLC
is a global biotechnology company that explores therapeutic
applications of unique, patented, ischemia-tolerant mesenchymal
stem cells manufactured under cGMP conditions. CardioCell is a
subsidiary of Stemedica Cell Technologies Inc., a global
biotechnology company that manufactures adult allogeneic stem
cells. The company's technology is based on more than 30 years of
research and clinical experience conducted by scientists and
physicians in the United States,
Europe and the former Soviet Union. CardioCell therapies offer a
unique, proprietary technology based on the expansion of cells in
constant hypoxia. The company has an exclusive, worldwide license
from Stemedica to explore therapeutic indications for unmet
cardiovascular needs, such as acute myocardial infarction, chronic
heart failure and peripheral artery disease. For more information,
visit www.stemcardiocell.com.
About Stemedica Cell Technologies Inc.
Stemedica Cell
Technologies Inc. is a global biopharmaceutical company that
manufactures best-in-class allogeneic adult stem cells and stem
cell factors. The company is a government licensed manufacturer of
cGMP, clinical-grade stem cells currently used in US-based clinical
trials for acute myocardial infarction, chronic heart failure,
cutaneous photoaging, ischemic stroke, Alzheimer's disease and
traumatic brain injury. Stemedica's products are also used on a
worldwide basis by research institutions and hospitals for
pre-clinical and clinical (human) trials. Stemedica is currently
developing additional clinical trials for other medical indications
using adult, allogeneic stems cell under the auspices of the FDA
and other international regulatory institutions. The company is
headquartered in San Diego,
California, and can be found online at
www.stemedica.com.
All media inquiries:
Kimberly
Stoddard
The Townsend Team
+1 415.806.5793
kimberly@townsendteam.com
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SOURCE CardioCell LLC