International Stem Cell Corporation (OTCBB:ISCO), www.internationalstemcell.com,
announced today the achievement of a major milestone in its efforts to
establish a bank of immune-matched parthenogenetic stem cells in the
United States by receiving the statutory approvals required to move
forward with the next phase of its stem cell banking program.
An independent Stem Cell Research Oversight (SCRO) committee approved
ISCO's program to obtain human oocytes (eggs) in California. The
independent SCRO committee is responsible for reviewing the scientific
rationale, ethics and compliance with State and Federal regulations and
guidelines for studies involving human stem cells. This approval in
combination with the earlier reported Institutional Review Board (IRB)
clearance with regard to medical safety opens the way for ISCO's stem
cell banking program to begin registering clinical investigators. ISCO's
study is designed to produce new clinical-grade human parthenogenetic
stem cell lines that can be immune matched to millions of individuals
for use in the emerging field of regenerative medicine.
ISCO's breakthrough discoveries have resulted in unique stem cells
carrying distinct advantages over other human pluripotent stem cells.
ISCO uses unfertilized oocytes to create human "parthenogenetic" stem
cells (hpSCs). Like human embryonic stem cells (hESCs), hpSCs are
pluripotent, i.e. they have the capacity to become almost any cell type
in the body, yet avoid ethical issues associated with use or destruction
of viable human embryos. Unlike hESCs, hpSCs can be created in a form
such that they can be immunologically matched to millions of individuals.
Currently ISCO has a collection of ten hpSC lines that are shared with
collaborators and used for research purposes. Although these ten stem
cell lines conform to all relevant US standards, they were derived
outside the United States. New cell lines created under this study will
be ISCO's first hpSC to be produced in the United States. ISCO's
scientists, leaders the field of creating therapeutic cells from hpSC,
will work with these lines targeting new treatments for human diseases.
The company will also share these cells with other scientists to further
clinical research. ISCO intends to derive and store these cells at its
Oceanside facilities, which are designed to create cells suitable for
clinical use.
Simon Craw, PhD, says, "These approvals, combined with our technology,
make the establishment of a bank of immune matched stem cells practical
and allow for the possibility of cell-based therapy to be economic for
millions of people. We believe we are one of the first commercial
entities in the United States to have progressed to this point."
ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):
International Stem Cell Corporation is a California-based biotechnology
company 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 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 sexes, ages and
racial groups. This offers the potential to create the first true stem
cell bank, UniStemCell™, while avoiding the ethical issue of using
fertilized eggs. 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 ISCO's
website, www.internationalstemcell.com
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FORWARD-LOOKING STATEMENTS
Statements pertaining to anticipated technological developments and
therapeutic applications, the potential benefits of collaborations, 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," "should,"
"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 therapies, uncertainty in the results of
clinical trials or 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 these forward-looking statements.
Key Words: Stem Cells, Biotechnology, Parthenogenesis
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Simon
Craw, PhD, Vice President
760-940-6383
sc@intlstemcell.com |
