A preclinical study involving
the injection of adipose-derived stem cells (ADSCs) into the myocardium
(heart muscle tissue) of infarcted rats, was recently completed at the
Jordan University of Science and Technology in Irbid, Jordan by medical and
veterinary doctors from that institution and the University of Jordan in
Amman, Jordan.
The study, led by Mahmoud Abu-Abeeleh, MD, Assistant Professor of
Cardiac Surgery, University of Jordan School of Medicine, Amman-Jordan,
showed evidence of regeneration of cardiomyocytes (heart cells) subsequent
to injection of ADSCs following heart attack, or acute myocardial
infarction (AMI). The study consisted of 99 nude rats* randomized into one
of six treatment arms (including a control group receiving
injection-vehicle containing cell media only). ADSCs for the treatment
groups were obtained from humans using the TGI 100 Cell Isolation System
for collection of endothelial progenitor cells (bone-marrow derived cells)
and stem cells from adipose (fat) tissue. Bioheart has secured an
exclusive, worldwide license to, upon commercial approval, sell or lease
the more advanced TGI 1200 System, manufactured by Tissue Genesis, Inc. for
the treatment of AMI.
Upon histological analysis, the control group animals showed a tendency
toward granular tissue formation (scar formation), active phagocytosis
(removal of pathogens or dead cells), variable angiogenesis (new blood
vessel formation) when evaluated at 10 days, early fibrosis (fibrous
connective tissue formation) when evaluated at 30 days and, in some cases,
established fibrosis when evaluated at 60 days. The treatment arms,
however, showed a tendency toward cardiomyocyte regeneration, prominent
angiogenesis (growth of new blood vessels) when evaluated at 10 days, and
reduction in the infarction size when evaluated at 60 days. In some of the
treated animals, minimal scarring area was observed when compared to the
control group, with as much as a 90 percent reduction in myocardial scar
size versus the average scar size of the control group.
Nude rats lack an immune system, which allows for the use of human
cells in preclinical studies.
These results are indicative of cardiomyocyte regeneration and suggest
that the injection of ADSCs after AMI may have the potential to help the
infarcted heart return to normal function.
"The study data suggest that injection of adipose-derived stem cells
decreased the amount of damage from myocardial infarction by assisting in
the formation of functional myocardial cells," said Dr. Abu-Abeeleh. "This
is a significant and encouraging finding, which adds to the growing body of
investigational evidence of using adipose-derived stem cells in the
treatment of heart attacks and warrants further study of Bioheart's Acute
Cell Therapy."
Fat tissue is an abundant and readily available source of endothelial
progenitor and adult stem cells and is easily extractable from a patient
using mildly invasive techniques.
The advanced TGI 1200 System is a compact, fully automated cell
isolation system for the rapid processing of patient-derived fat tissue to
separate, isolate and produce large yields of endothelial progenitor cells
and stem cells. Tissue Genesis, Inc., is currently seeking certification to
apply the CE Mark for commercial sale and distribution of the TGI 1200 as a
tissue processing system within the European Union. The study, sponsored by
Bioheart, Inc., was organized by the Philadelphia BioMed Product
Development Centre, an indirect wholly owned subsidiary affiliated with a
member of Bioheart's Board of Directors. Study objectives included
assessment of the distribution and phenotype of the transplanted ADSCs and
complete macroscopic exam and histopathology of selected tissues in a total
of six differentiated study groups of approximately 15 subjects each.
A proposed pathway for seeking regulatory approval of Bioheart Acute
Cell Therapy using the TGI 1200 System has been developed and additional
preclinical studies involving pigs, testing for the safety and efficacy of
the therapy, commenced in the first quarter of 2007 at Indiana University.
"We are very proud of our pre-clinical work with adipose-derived stem
cells," said Howard J. Leonhardt, Bioheart CEO and Chief Technology
Officer. "We hope that this and other pre-clinical studies will allow us to
obtain IND approval for the start of a human clinical trial involving these
cells for use in patients soon after they have a heart attack."
"The results of these Bioheart preclinical studies affirm our belief
that the adipose-derived cells isolated from adipose tissue by the TGI
System have the potential to assist in the treatment of a variety of
medical conditions, including heart attacks," said Anton C. Krucky,
President and CEO, Tissue Genesis, Inc. "We are excited to be associated
with the foundational work of Bioheart in this area of potential heart
treatment."
ABOUT ACUTE MYOCARDIAL INFARCTION
Acute myocardial infarction (heart attack), results from the sudden
deprivation of circulating blood to the myocardium (heart). This results
from the clogging of an artery, potentially due to a build-up of
cholesterol in the inner wall of blood vessels that distribute blood to the
heart muscle, or thrombosis (clot). This can lead to a part of the heart
muscle becoming permanently damaged, resulting in some death of myocardial
tissue (necrosis). Each year, more than one million people in the United
States suffer a heart attack.
ABOUT BIOHEART, INC.
Bioheart, Inc. (Nasdaq: BHRT) is committed to delivering intelligent
devices and biologics that help monitor, diagnose and treat heart failure
and cardiovascular diseases. Its goals are to improve a patient's quality
of life and reduce health care costs and hospitalizations. Specific to
biotechnology, Bioheart is focused on the discovery, development and,
subject to regulatory approval, commercialization of autologous cell
therapies for the treatment of chronic and acute heart damage. Its lead
product candidate, MyoCell(R), is an innovative clinical muscle-derived
stem cell therapy designed to populate regions of scar tissue within a
patient's heart with new living cells for the purpose of improving cardiac
function in chronic heart failure patients. The Company's pipeline includes
multiple product candidates for the treatment of heart damage, including
Bioheart Acute Cell Therapy, an autologous, adipose tissue-derived stem
cell treatment for acute heart damage, and MyoCell(R) SDF-1, a therapy
utilizing autologous cells that are genetically modified to express
additional potentially therapeutic growth proteins. For more information on
Bioheart, visit bioheartinc.
ABOUT TISSUE GENESIS, INC.
Tissue Genesis, Inc. (tissuegenesis) is a leader in adipose
(fat) derived regenerative medicine solutions to address a wide range of
therapeutic needs including vascular, cardiovascular, and other
regenerative medical applications. The company expects its technology,
expertise and products to isolate autologous adipose-derived regenerative
cells at the point of care for immediate patient needs. Through its
business partners, such as Bioheart, the company is extending the
development and application of its technology and platform products to
reach worldwide markets in the potential wide use of cell therapy.
Forward Looking Statements:
Except for historical matters contained herein, statements made in this
press release are forward-looking and are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. Without
limiting the generality of the foregoing, words such as "may", "will",
"to", "plan", "expect", "believe", "anticipate", "intend", "could",
"would", "estimate", or "continue" or the negative other variations thereof
or comparable terminology are intended to identify forward-looking
statements.
Investors and others are cautioned that a variety of factors, including
certain risks, may affect our business and cause actual results to differ
materially from those set forth in the forward-looking statements. These
risk factors include, without limitation, (i) our ability to secure
additional financing; (ii) the timely success and completion of our
clinical trials; (iii) the occurrence of any unacceptable side effects
during or after preclinical and clinical testing of our product candidates;
(iv) regulatory approval of our product candidates;(v) our dependence on
the success of our lead product candidate; (vi) our inability to predict
the extent of our future losses or if or when we will become profitable;
(vii) our ability to protect our intellectual property rights; (viii) our
inability to predict the extent of our future losses or if or when we will
become profitable; and (viii) intense competition. The company is also
subject to the risks and uncertainties described in its filings with the
Securities and Exchange Commission, including the section titled "Risk
Factors" in its Annual Report on Form 10-K for the year ended December 31,
2007, as amended by Amendment No. 1 on Form 10-K/A and its quarterly report
on Form 10-Q for the quarters ended March 31, 2008 and June 30, 2008.
Bioheart, Inc.
bioheartinc
Bioheart Reports Promising Results From Preclinical Study Of Adipose Derived Acute Cell Therapy
02
07
2015