HepaLife Technologies, Inc. (OTCBB:HPLF) (FWB:HL1) (WKN:500625),
Boston, Mass., developer of the first-of-its-kind artificial liver
device, has announced significant early results of new in-vitro studies
involving the company's patented PICM-19 liver stem cells, which
were placed inside its proprietary artificial liver device and were able
to favorably produce urea and successfully remove ammonia, a highly
toxic by-product which causes brain damage, coma, and even death.
"Today's results demonstrate that, while inside our
bioartificial liver device, HepaLife's PICM-19 cells are able to
produce substantial amounts of urea and remove toxic ammonia, while
remaining healthy, and replicating important liver-like functions,"
stated Frank Menzler, president and CEO of HepaLife. "This is a
significant achievement that marks a major milestone in the development
of our artificial liver device. "These new results have certainly
exceeded our early performance expectations of the HepaLife
bioartificial liver design. Our goal is to now further evaluate the
HepaLife bioartificial liver system in-vitro and in-vivo, and continue
to move closer to an application with the Food and Drug Administration
for our cell-based device."
According to researchers, the most vital component in an artificial
liver device is not the mechanical hardware, but rather, it is the
biological cells inside the device which are responsible for truly
replicating and performing the functions of the human liver, similar to
the functions mimicked by HepaLife's PICM-19 cells in today's
research outcomes. Research data from experiments of the PICM-19 cells
inside HepaLife's artificial liver device indicates 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 study
after two weeks. 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 are not contact-inhibited tend to become
cancerous. In contrast, HepaLife's PICM-19 cells inside its liver
device system did not develop tumors or become cancerous, but rather,
remained 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' physical form and
structure. In evaluating the chemical function and overall health of the
PICM-19 liver cells inside HepaLife's bioartificial liver system,
researchers analyzed levels of lactate and glucose -- indicators of
metabolic function -- alongside oxygen and carbon dioxide, respectively.
In all cases, these monitored levels remained favorably within targeted
parameters throughout the duration of the studies.
"These results suggest that HepaLife's bioartificial
liver system is an artificially created, "living biosystem" --
our goal from the early beginning -- with cells that behave as we have
long desired for our artificial liver device," concluded Menzler.
Intended for the treatment of liver failure, the HepaLife
Bioartificial Liver device consists of three basic components: (1) a
plasma filter, separating the patient's 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, 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.
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.
About Hepalife Technologies, Inc.
HepaLife Technologies, Inc. (OTCBB:HPLF) (FWB:HL1) (WKN:500625) is
a developer of cell-based medical technologies addressing prevalent
human health concerns.
Current cell-based technologies under development by HepaLife
include 1) the first-of-its-kind artificial liver device, 2) proprietary
in-vitro toxicology and pre-clinical drug testing platforms, and 3)
novel cell-culture based vaccine production methods for the manufacture
of vaccines against H5N1 avian influenza and other viruses.
For more information, visit http://www.hepalife.com or call
800/518-4879.
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