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
