International Stem Cell Corporation (OTCBB:ISCOE) announces the
discovery of a novel, patent-pending technology to produce unlimited
numbers of liver cells (hepatocytes) that are free of contamination with
potentially dangerous undifferentiated cells. The technology is based on
the natural, physiological properties of the cellular environment, and
does not require any additional purification of the final product. The
starting materials for the production are pluripotent stem cells, either
ISCO's proprietary human parthenogenetic stem cells (hpSCs) or human
embryonic stem cells (hESCs).
The technology is described in a new article that will appear in Cell
Transplantation, the Regenerative Medicine Journal (currently the
article is available only in electronic form). The published data also
reinforce that hpSCs can provide the cellular material necessary for the
implementation of cell-based therapies.
Marie Csete, M.D., Ph.D., co-author of the paper, said, "Derivation of
differentiated cell products that are not contaminated with
undifferentiated cells solves a major technical roadblock in the
development of all pluripotent stem cell-based therapies because
undifferentiated stem cells with tumorigenic potential can persist
through long differentiation protocols. Therefore methods to generate
pure differentiated cells for transplantation are critical for creating
successful cell therapies. Furthermore, the elegant technology developed
by ISCO scientists to enforce critical steps in differentiation
illustrates the power and importance of basic engineering tools in stem
cell biology."
Nikolay Turovets, Ph.D., Director of Research and Therapeutic
Development at ISCO and co-author of the paper stated, "The technology
discovered by our research team is based on reproducing features of the
normal human embryonic microenvironment. The method uses a
differentiation device that incorporates a three-dimensional
extracellular matrix, combined with a porous membrane. Treatment of
undifferentiated cells above the membrane using differentiation-directed
proteins results in permitting the desired cells to migrate through the
membrane into the matrix, where they further differentiate into
functional hepatocytes."
Jeffrey Fair, M.D., liver transplant surgeon and Director of
Translational Research for the Cedars-Sinai Comprehensive Transplant
Center and Department of Surgery in Los Angeles, and co-author of the
paper said, "Derivatives of HLA-homozygous hpSCs are likely to be
significantly less susceptible to immune rejection after
transplantation, thus offering major advantages over other pluripotent
cell sources of hepatocytes. In the paper, we demonstrated that
hepatocytes derived from hpSCs in this differentiation system
demonstrate activities that are missing in a number of metabolic liver
diseases, such as expression of AAT and OTC genes. Thus, personalized
HLA-matching, as well as presence of the required activities make the
pure hepatocyte population derived from hpSCs an attractive development
candidate for cell therapy of metabolic liver diseases, urea cycle
disorders, AAT-deficiency or other liver diseases in which a single
hepatocyte product can ameliorate disease."
The approach used to derive a pure hepatocyte population is a technology
platform that may allow derivation of various cell populations from
different sources.
Andrey Semechkin, Ph.D., President and CEO of ISCO, and co-author of the
paper stated, "We have discovered technology that has a number of
features and advantages, and our plans are to expand the applications of
this platform to develop new products. This system is universal and does
not depend of the particularities of cell lines. As such it could be
successfully used with hpSCs, hESCs and, we believe, with induced
pluripotent stem cells (iPSs). Because isolation of undifferentiated
cells happens at the first step of the differentiation procedure, the
technology could be used to isolate other cell types, for example
pancreatic or heart cells. Also, because technology is based on a
natural process, cell separation is accomplished without any cell
damage, in contrast to physical purification methods such as FACS, or
magnetic sorting."
An electronic pre-copy-edited version of the paper entitled "Derivation
of high-purity definitive endoderm from human parthenogenetic stem cells
using an in vitro analog of the primitive streak" is available
at: http://www.ingentaconnect.com/content/cog/ct/pre-prints/ct0284agapova.
A color version of the paper will be available when the print
publication is issued. Prior to print publication, color figures can be
obtained upon request from Nikolay Turovets, PhD: nturovets@intlstemcell.com.
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic
applications of human parthenogenetic stem cells and the development and
commercialization of cell-based research and cosmetic products. ISCO's
core technology, parthenogenesis, results in the creation of pluripotent
human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical
issues associated with the use or destruction of viable human embryos.
ISCO scientists have created the first parthenogenic, homozygous stem
cell line that can be a source of therapeutic cells with minimal immune
rejection after transplantation into hundreds of millions of individuals
of differing genders, ages and racial background. This offers the
potential to create the first true stem cell bank, UniStemCell™. ISCO
also produces and markets specialized cells and growth media for
therapeutic research worldwide through its subsidiary Lifeline Cell
Technology, and cell-based skin care products through its subsidiary
Lifeline Skin Care. More information is available at www.internationalstemcell.com.
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Forward-looking Statements
Statements pertaining to anticipated developments, the potential
production and benefits of stem cell lines, the potential applications
and benefits of the new technology, and other opportunities for the
company and its subsidiaries, along with other statements about the
future expectations, beliefs, goals, plans, or prospects expressed by
management constitute forward-looking statements. Any statements that
are not historical fact (including, but not limited to statements that
contain words such as "will," "believes," "plans," "anticipates,"
"expects," "estimates,") should also be considered to be forward-looking
statements. Forward-looking statements involve risks and uncertainties,
including, without limitation, risks inherent in the development and/or
commercialization of potential products and new technologies, regulatory
approvals, need and ability to obtain future capital, application of
capital resources among competing uses, and maintenance of intellectual
property rights. Actual results may differ materially from the results
anticipated in these forward-looking statements and as such should be
evaluated together with the many uncertainties that affect the company's
business, particularly those mentioned in the cautionary statements
found in the company's Securities and Exchange Commission filings. The
company disclaims any intent or obligation to update forward-looking
statements.
International Stem Cell Corporation 760-940-6383 Kenneth C.
Aldrich Chairman kaldrich@intlstemcell.com or Nikolay
Turovets, Ph.D. Director of Research and Therapeutic Development nturovets@intlstemcell.com or: Lippert/Heilshorn
& Associates Don Markley (dmarkley@lhai.com) 310-691-7100
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