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
Phase IIa clinical trial "Safety and Efficacy of Intravenous
Infusion of Ischemia-Tolerant Allogeneic Mesenchymal Stem Cells in
Patients With Non-ischemic Cardiomyopathy" at the European Society
of Cardiology (ESC) Congress. Dr. Javed Butler – one of the study's
protocol designers, as well as Chief of the Cardiology Division and
Co-Director of the Heart Institute at Stony Brook University –
presents a "Hot Line" Late-Breaking Science Session illustrating
statistically significant improvement in 6-minute walk test,
quality-of-life scores as assessed by Kansas City Cardiomyopathy
Questionnaire (KCCQ) and favorable immune modulatory benefits. This
represents the first clinical trial to study the effects of
intravenous (IV) administration of ischemia-tolerant mesenchymal
stem cells (itMSCs) in patients with chronic heart failure
(HF).
"The study's premise was that the stem cell benefits may be
related to their paracrine properties," says Dr. Javed Butler, Chief of the Cardiology Division
and Co-Director of the Heart Institute at Stony Brook University.
"We hypothesized that these benefits should also be retained with
IV administration, and, theoretically, enhanced in HF patients who
do not have any evidence of myocardial scarring. The results
support that IV administration is a safe and viable strategy that
has the potential to offer significant health benefits."
Results Validate Safety and Potential Benefits of IV itMSC
Administration
The study protocol tests safety and capacity
of CardioCell's itMSCs to exert beneficial effects via IV
administration. The methodology demonstrates that the systemic
effects of intravenously delivered itMSCs can be measured and is
associated with improved patient outcomes. Results show that an IV
injection strategy is safe and well-tolerated. There are no major
differences in any of the safety endpoints, including clinical
events like all-cause mortality, all-cause hospitalization and
adverse events, and there are no alterations in pulmonary function,
liver function or arrhythmias. In addition, IV itMSC injections
exhibit improvements in several clinical-efficacy endpoint
measurements, including statistically significant improvement in
6-minute walk test (P=0.02); KCCQ Clinical Summary score (P=0.02)
and trend to improvement in KCCQ Functional Status score (P=0.06).
The study also demonstrates that intravenously administered itMSCs
suppress inflammation, which is noteworthy because inflammation is
believed to importantly contribute to HF progression. There was a
statistically significant reduction in natural killer (NK) cells,
the magnitude of which correlated with the magnitude of improvement
in left ventricular ejection fraction (LVEF). Overall, there was no
difference in cardiac structure and function. In an exploratory
data analysis before the 90-day crossover, there was a
statistically significant improvement in the left ventricular end
systolic and diastolic volumes in the itMSC-treated groups, whereas
this was not seen in the placebo-treated group.
IV itMSC Administration Opens New Possibilities for Future
Stem Cell Therapies
It was previously assumed that large
amounts of stem cells must be delivered directly to the myocardium
to improve patient outcomes. However, this delivery mechanism –
either via catheter or by surgery – is not practical for such
chronic conditions as HF, where multiple treatments may be needed.
The results of this study suggest that IV itMSC administration
could potentially provide a more practical alternative that offers
health benefits.
"It is exciting to be part of the first IV stem cell
administration study that showed a significant functional
improvement for HF patients," says Dr. Mihai Gheorghiade, a
protocol co-designer of this study and Director of Experimental
Therapeutics at the Center for Cardiovascular Innovation at
Northwestern University Feinberg School
of Medicine, Co-chair of CardioCell's Heart Failure Advisory Board
and Member of CardioCell's Scientific Advisory Board. "Importantly,
itMSCs improved well-being of the patients that have already been
on evidence-based HF therapy. This is very innovative and marks a
new beginning in HF management, especially in light of negative
results of many drug-intervention trials."
Clinical Trial Offers Implications for Further
Study
This study indicates that IV itMSC administration may
lead to improvement in patient well-being and exerts associated
anti-inflammatory effects. Current data suggests that paracrine
signaling is mostly responsible for these signs of improvements,
which suggests an IV delivery method is viable. Further, IV
administration is more practical than local administration.
"Based on these promising clinical-trial findings, CardioCell is
excited to be developing larger studies based on IV delivery of our
itMSCs for heart failure indications, including both non-ischemic
and ischemic cardiomyopathy," says Sergey Sikora, CEO of CardioCell
and co-author of the study. "We are very encouraged by the degree
of statistically significant improvement in patient health status,
and we look forward to exploring whether multiple IV treatments
will lead to further improvement, including cardiac function."
About the Phase IIa Clinical Trial
The single-blind,
placebo-controlled, crossover study – conducted at Emory University, Northwestern
University, Stony Brook University and the University of Pennsylvania – delivered itMSCs via
IV infusion to 22 enrolled patients with non-ischemic
cardiomyopathy and LVEF ≤40%. The study randomized patients into a
treatment group and a control group with a 1:1 randomization
scheme. CardioCell's treatment and the placebo were administered
intravenously. Progress was tracked at the baseline, at 90 days and
at 180 days and was measured by the KCCQ, 6-minute walk, NYHA and
cardiac MRI. At 90 days after the first injection, the control
group received CardioCell's treatment, and the original treatment
group received the placebo solution. At Duke
University's cardiac imaging core laboratory, the MRI images
were analyzed by Dr. Raymond Kim,
founder and co-director of the Duke Cardiovascular Magnetic
Resonance Center. Study authors include Javed Butler M.D., MPH, MBA; Stephen E. Epstein M.D.; Stephen J. Greene M.D.; Arshed A. Quyyumi M.D.;
Sergey Sikora Ph.D.; Raymond J. Kim
M.D., Ph.D.; Allen S. Anderson
M.D.; Jane E. Wilcox M.D.;
Nikolai I. Tankovich M.D.;
Michael J. Lipinski M.D.;
Kenneth B. Margulies M.D.;
Robert T. Cole M.D.; Hal A. Skopicki M.D., Ph.D.; and Mihai Gheorghiade M.D.
About itMSCs
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 chronic 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