HepaLife(TM) Surpasses Significant Milestones in Development of
Artificial Liver Device
Monday, December 17, 2007; Posted: 09:15 AM
BOSTON, Dec 17, 2007 (BUSINESS WIRE) -- HPLF | charts | news |
PowerRating -- HepaLife Technologies, Inc. (OTCBB:HPLF) (FWB:HL1)
(WKN:500625) is pleased to announce details of a series of
significant achievements in the development of the first-of-its-
bioartificial liver device, allowing the Company to move closer to
initial in-vivo trials.
Key to the success of the Company's artificial liver device are
HepaLife's patented PICM-19 embryonic liver stem cells, which
scientists have demonstrated possess a number of unique
characteristics, making their liver-specific metabolic functionality
superior to other cells, including the world's most widely used human
liver cell line.
The unique functionality of the PICM-19 cells allow them to
successfully mimic the human liver's response in several important
ways, including their ability to express high levels of cytochrome P-
450 enzymes, a key liver-related function in the detoxification of
drugs and xenobiotics, and to favorably produce urea and successfully
remove ammonia, a highly toxic by-product which causes brain damage,
coma, and even death.
"Not only is HepaLife's PICM-19 cell line the only known embryonic
liver stem cell line of its kind with the ability to produce
substantial amount of urea, but it also uniquely differentiates into
hepatocytes (liver cells) or bile duct epithelium," states Mr. Frank
Menzler, President and CEO of HepaLife Technologies, Inc.
"Now, with the integration of the PICM-19 cell into our proprietary
bioreactor and perfusion system, the concept of the HepaLife
bioartificial liver is nearly complete. This year has been remarkable
and we continue to overachieve on our goals, both from a corporate
and scientific perspective, moving us closer to initial in-vivo
trials."
HepaLife's BioArtificial Liver
One of the main functions of the human liver is the detoxification of
ammonia, which is primarily done through the synthesis of urea.
Patients with acute liver failure or genetic liver diseases are often
unable to remove ammonia from the bloodstream, leading to brain
damage, coma, and death.
In previous tests, HepaLife's PICM-19 cells were able to successfully
synthesize 100% of the ammonia present, almost four times more than
HepG2-C3A, currently the world's most widely-used human liver cell
line. Most significantly, a large proportion of the ammonia was
specifically synthesized into urea by the PICM-19 cells. In
comparison, HepG2-C3A synthesized none of the ammonia into urea.
Notably, HepaLife's PICM-19 cell line is the only known embryonic
liver stem cell line of its kind with the ability to produce
substantial amounts of urea in an in-vitro system.
Results also demonstrated that the PICM-19 cells are able to express
high levels of cytochrome P-450 enzymes, a key liver related function
in the detoxification of drugs and xenobiotics. In contrast, HepG2-
C3A showed very low, or no detectable P-450 activity at all.
Incorporating the PICM-19 cell line, HepaLife is developing the first-
of-its-kind bioartificial liver. HepaLife's bioartificial liver,
currently under development, is designed to operate outside the
patient's body. The bioartificial liver is envisioned to mimic
important functions of the human liver by circulating the patient's
blood inside the device, where it is exposed to HepaLife's patented
PICM-19 liver stem cells, thus processing the patient's blood-plasma
by removing toxins, enhancing metabolic function, and ultimately
imitating the liver's natural function.
Intended for the treatment of liver failure, the HepaLife
bioartificial liver device consists of three basic components: (1) a
plasma filter, separating the patients blood into blood plasma and
blood cells; (2) the bioreactor, a unit filled with PICM-19 cells
which biologically mimic the liver's function; and (3), the HepaDrive
(TM), a perfusion system for pumping the patient's plasma through the
bioreactor while controlling gas supply and temperature for best
possible performance of the cells.
Long running in-vitro tests of the HepaLife bioartificial liver
showed that the system removed toxic ammonia, and successfully
produced significant amounts urea and liver specific protein, such as
albumin, over the entire duration of the study. Most importantly, the
production of urea and albumin increased over time, reaching peak
levels at termination of the two week study.
In observations of cell replication and growth, researchers confirmed
earlier findings where PICM-19 liver cells remained contact-
inhibited, an important indicator of normal cell growth, since cells
which lack contact-inhibition tend to become cancerous. In contrast
to cells which are not contact-inhibited, HepaLife's PICM-19 cells
did not develop tumors nor become cancerous inside the liver device
system, instead remaining non-tumorigenic.
In the same tests, HepaLife's PICM-19 liver stem cells successfully
differentiated into hepatocytes (liver cells) displaying normal
morphology, an indication of the cells' natural physical form and
structure.
In evaluating the chemical function and overall health of the PICM-19
liver cells inside HepaLife's bioartificial liver, researchers
analyzed levels of lactate and glucose -- indicators of metabolic
function -- alongside oxygen and carbon dioxide. In all cases, these
monitored levels remained favorably within targeted parameters
throughout the duration of the studies.
"The combination of the superior metabolic performance of our PICM-19
cell line along with our new bioreactor and perfusion system truly
sets us apart from anyone else. Each new step we take along the
development pathway brings us that much closer to creating the
world's first-of-its-
Menzler.
http://www.tradingm
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Cord Blood Registry
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The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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