RegBlog: Over-Regulation of Parthenotes Stifles Valuable Scientific Research - by Sean J. Kealy

A recent article in Scientific American questioned whether research on stem cell lines derived from unfertilized eggs was too tightly regulated by the federal government.  Now that technology allows the creation of stem cells without fertilization, there is no question that federal laws and guidelines are overly restrictive, causing a detrimental effect on valuable scientific inquiry.  

Since 1996, Congress has included the Dickey-Wicker Amendment in the annual federal budget.  This amendment was a conservative reaction to what some considered to be scientific research that showed little respect toward life.  

For example, speaking to the Senate in 1996, Robert Smith (R-NH) said, “Just because a private party wants to destroy life, why should Government force taxpayers to give their blessing to that act?  Let private parties use private money for their ethically challenged experiments.”  Similarly, Representative Jay Dickey (R-AR) said, also in 1996, that embroyonic research was “an attack on the sanctity of life,” and pointed out that several pro-life organizations supported the amendment. 

Please click here to read the complete article. 

Source: http://www.law.upenn.edu/blogs/regblog/2011/12/over-regulation-of-parthenotes-stifles-valuable-scientific-research.ht

International Stem Cell Comments on Recent SCIENTIFIC AMERICAN Article: “You Say Embryo, I Say Parthenote”

“We at International Stem Cell Corporation (ISCO.OB) are finding it increasingly gratifying that mainstream and highly respected publications like Scientific American are now beginning to take notice of the fact that our Parthenogenetic Stem cells have tremendous potential to accelerate disease cures, lower health care costs, and create jobs here in America -- all free from the bioethical issues that have long clouded the stem cell debate."

Like embryonic stem cells, our Parthenogenetic stem cells can be converted into almost any kind of cell that might ever be needed for therapy, but can also provide a solution to the two biggest issues that have surrounded embryonic stem cell research: 1) the ethics of destroying a fertilized embryo, which our process never does, and 2) the problem of immune rejection by the patient.  We hope you enjoy the attached article." 

Ken Aldrich, Founder and Co-Chairman, International Stem Cell Corporation

October 21^st, 2011

“You Say Embryo, I Say Parthenote”

Stem cells from unfertilized eggs may be too tightly regulated

By Julia Galef

Article: http://www.scientificamerican.com/article.cfm?id=you-say-embryo-i-say-parthenote

Source: Scientific America November 2011

International Stem Cell Corporation presents "The Promising Cells" Video

In this video presentation, see and hear an overview of International Stem Cell Corporation (ISCO.OB). ISCO has developed a process to derive stem cells similar to Embryonic Stem Cells without the need for fertilized embryos and with minimal exposure to non-human cells. These factors provide ISC a unique leadership role in the field of regenerative cell therapy. You'll hear directly from Executive Chairman, Kenneth Aldrich. Lifeline Cell Technology and Skin Care Products, revenue generating units of ISCO are also reviewed.

This presentation was produced by Big Sky Productions, INC (BGSI.OB), Co-Executive Producers Ellis Martin and Bob Lange. 

contact: bigskymedia@yahoo.com

International Stem Cell Corporation's Senior VP Jeffrey Janus Comments on "ACT Awarded Patent for Stem Cell Generation Technique"

"The granting of this patent is an excellent step forward in the search for new techniques to derive stem cells and treat diseases with stem cell therapy. As a licensee of this technology for several of our target stem cell applications, we at International Stem Cell Corporation are delighted that our scientists have yet another tool with which to work."

Jeffrey Janus, Senior VP, International Stem Cell

ACT Awarded Patent for Stem Cell Generation Technique

Original Article Source - Mass High Tech

Advanced Cell Technology Inc. has been given a patent for its nondestructive technique of obtaining human embryonic stem cell (hESC) lines. Called “single-blastomere” technology, the technique was referred to in a statement by ACT interim chairman and CEO Gary Rabin as “one of the most significant” among the Marlborough biotech’s more than 150 patents and patent applications.

“It will help us accelerate our progress on a number of fronts, including deriving embryonic stem cells which meet the regulatory standards of the European Medicines Agency and the US Food and Drug Administration, using the single-blastomere technology,” Rabin said, in the statement.

ACT (OTCBB: ACTC) said in a news release that its single-blastomere technique avoids embryo destruction by using a one-cell biopsy approach.

In January, the company pulled in a $25 million financing and was cleared by the FDA for its Investigational New Drug application to use hESCs in treating Dry Age-Related Macular Degeneration.

Rabin has been serving in his interim roles at ACT since mid-December, when William M. Caldwell IV, then chairman and CEO, died unexpectedly. Caldwell had held the CEO role of ACT since 2005 and the chairman post since 2006.

International Stem Cell Corporation: Note From The CEO Andrey Semechkin

"Since releasing our press release this morning announcing that ISCO.OB had successfully created enriched cell cultures that might be used to treat diabetes or liver disease, people have asked, 'What does that really mean?’

The simple answer is that it further proves ISCO’s Parthenogenetic stem cells can do the same things that can be done with embryonic stem cells, but without raising the ethical issues of using cells from fertilized embryos and with a real chance to solve one of the toughest problems in cell therapy—how do you keep the human body from rejecting a cell transplant before the transplant can treat the disease.

Scientists already know that they can treat liver disease and diabetes with human cells. The problems have been to find an ethical supply of cells in sufficient quantity and prevent the body from rejecting those cells. We think this is a major step toward the pathway and it enables ISCO to stand on the shoulders of 10 years of prior research to reach the next rung of the ladder to a cure for both of these life threatening diseases.

ISCO’s latest press release reflects a major step in the direction of treating diabetes and liver disease with its cells."

International Stem Cell's Scientists in Collaboration with World Leading Stem Cell Experts Extend Understanding of Human Parthenogenetic Stem Cells...

International Stem Cell's Scientists in Collaboration with World Leading Stem Cell Experts Extend Understanding of Human Parthenogenetic Stem Cells in Peer-Reviewed Publications International Stem Cell Corporation (OTCBB:ISCO), www.internationalstemcell.com, in collaboration with leading stem cell scientists, announces findings that human parthenogenetic stem cells (hpSC) and human embryonic stem cells (hESC) are similar in their undifferentiated state, and are capable of differentiating into neural lineages such as functional retinal pigment epithelial (RPE) cells that have potential to treat retinal diseases such as age-related macular degeneration. ISCO's CEO Andrey Semechkin, Ph.D., said: "These data are extremely important as they demonstrate that parthenogenetic stem cells have therapeutic potential like conventional embryonic stem cells; however, parthenogenetic stem cells have the additional benefit of superior immune-matching capabilities." This evidence is presented in a recently published paper entitled: "Equivalence of conventionally-derived and parthenote-derived human embryonic stem cells" published in PLoS ONE (Public Library of Science). Hans Keirstead, Ph.D., Professor of Anatomy and Neurobiology and Neurological Surgery at the University of California, Irvine and the senior author of the paper, said: "This work is the first wide-ranging comparison between these two important pluripotent stem cell types and demonstrates that human parthenogenetic stem cells are capable of differentiation along retinal lineages." According to Nikolay Turovets, Ph.D., ISCO's Director of Research and Therapeutic Development and co-author of the paper, "Derivation of RPE from hpSC is the next logical step on the way to developing patient-specific therapies to treat eye degenerative disorders. If studies using RPE derived from hESC demonstrate utility in treating such diseases, it may become necessary to address problems associated with immune rejection. RPE derived from hpSC can be better immune-matched to the patient, thus reducing the chance of immune rejection." This work forms part of ISCO's ophthalmology program developed in collaboration with the team of scientists at the University of California, Irvine led by Dr. H. Keirstead. One of the principal aims of the program is to create three-dimensional retinal tissue for transplantation that may be used to rescue the vision of individuals with retinitis pigmentosa, a group of inherited disorders characterized by progressive vision loss. ISCO has established collaborations with other leading stem cell researchers to exploit the unique qualities of hpSCs. In addition to the collaboration with Keirstead, ISCO scientists co-authored a publication with Jeanne Loring, Ph.D., the Director of the Center for Regenerative Medicine at The Scripps Research Institute in La Jolla, entitled "Dynamic changes in the copy number of pluripotency and cell proliferation genes in human ESCs and iPSCs during reprogramming and time in culture" published in Cell Stem Cell in January, 2011. Ruslan Semechkin, Ph.D., Vice President of ISCO and co-author on this paper, said: "We are excited about being involved in Dr. Loring's work, which compares molecular characteristics of hundreds of different human pluripotent cell lines." Dr. Loring added: "hpSCs are intriguing because they are pluripotent like hESCs, but have differences in imprinting, the process in embryonic development in which certain genes are inactivated. This makes hpSCs tremendously valuable for understanding the molecular basis of the imprinting process in humans." 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. To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0. FORWARD-LOOKING STATEMENTS Statements pertaining to anticipated technological developments and therapeutic applications, 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, 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 Jeffrey Janus, Senior VP 760-940-6383 jjanus@intlstemcell.com

ISCO Enters into an Agreement with Cytograft Tissue Engineering to Develop a Therapeutic Medium for Cytograft's Living Vascular Grafts

Living Laboratory Grown Blood Vessels from the Patient's Own Cells

International Stem Cell Corporation (OTCBB:ISCO) (www.intlstemcell.com), the first company to perfect a method of creating human "parthenogenetic" stem cells, which are derived from unfertilized human eggs, is working with tissue engineers at Cytograft Tissue Engineering, (Novato, CA), to design a custom cell culture medium to cultivate living human vascular grafts; grafts which are expected to be used in future human clinical trials.

Cytograft's living human product, called Lifeline™ (trade-name not associated with Lifeline Cell Technology), is a promising technology that will be used as a coronary graft for coronary bypass procedures, as a peripheral graft to prevent lower limb amputations and as a living tissue shunt for hemodialysis patients.

The new medium will be developed and produced by scientists at ISCO's wholly-owned subsidiary, Lifeline Cell Technology®, a producer of human cells and media products.

"It is an honor that Cytograft chose Lifeline Cell Technology's team to develop their medium. Their process of growing human vascular grafts promises to be a vast improvement over synthetic materials. Since the grafts are grown using the patient's own cells, they will minimize the chance of immune rejection, infection and disease transmission," said Jeffrey Janus, CEO of Lifeline Cell Technology.

According to Todd McAllister PhD, CEO of Cytograft, "The team at Lifeline Cell Technologies is uniquely qualified to develop and design custom media formulations for our application. They clearly have one of the best scientific teams in the field, and, importantly, have a service based business model that has been flexible and responsive to our specific requirements."

International Stem Cell Corporation (ISCO.OB) is a California biotechnology company focused on developing therapeutic and research products. ISCO's technology, Parthenogenesis, results in the creation of pluripotent human stem cell lines from unfertilized human eggs. These "parthenogenetic" stem cells can be a source of therapeutic cells that will minimize immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. Lifeline Cell Technology develops and manufactures human cell culture products for research into human disease and toxicology. These products consist of human cells and low-serum or serum-free media to grow the cells.

For more news and information on International Stem Cell Corporation please visit www.IRGnews.com/coi/ISCO where you can find the CEO's video, a fact sheet on the company, investor presentations, and more.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):
International Stem Cell Corporation is a California biotechnology company focused on developing therapeutic and research products. ISCO's technology, Parthenogenesis, results in the creation of pluripotent human stem cell lines from unfertilized human eggs. ISCO scientists have created the first Parthenogenetic homozygous stem cell line (phSC-Hhom-4) that can be a source of therapeutic cells that will minimize immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. These advancements offer the potential to create the first true "Stem Cell Bank" and address ethical issues by eliminating the need to use or destroy fertilized embryos. ISCO also produces and markets specialized cells and growth media worldwide for therapeutic research through its subsidiary Lifeline Cell Technology. For more information, visit the ISCO website at: www.internationalstemcell.com.
To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.


FORWARD-LOOKING STATEMENTS:
Statements pertaining to anticipated future financial and/or operating results, future growth in research, technology, clinical development and potential joint venture and other opportunities for the company and its subsidiary, 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, 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, CEO760-940-6383kaldrich@intlstemcell.com
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Jeffrey Janus, President760-940-6383jjanus@intlstemcell.com
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The Investor Relations Group212-825-3210Investor Relations:Adam S. Holdsworthaholdsworth@investorrelationsgroup.com
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Media Relations:Laura Colontrellelcolontrelle@investorrelationsgroup.com