International Stem Cell Corporation (OTCBB:ISCO), the first company to perfect a method of creating human "parthenogenetic" stem cells from unfertilized eggs, has received positive early results from animal trials designed to improve photorefractive keratectomy (PRK), a form of corrective laser eye surgery that offers an improved alternative to LASIK.
PRK is generally thought to be safer and produce better long-term results than LASIK, but has not been used as frequently because of patient discomfort following surgery and a longer healing time. By combining ISCO's human corneal cells with a proprietary surgical device developed by Paul H. Chen, M.D., who is conducting the trials, ISCO and Dr. Chen believe that cellular enhanced PRK can replace LASIK for many of the hundreds of thousands of patients who now use LASIK.
The first stage animal trials just completed demonstrated that ISCO's corneal cells manufactured by ISCO's subsidiary, Lifeline Cell Technology, encouraged corneal-defect healing in the animals. The trials are the first step toward gaining Food and Drug Administration (FDA) approval to test the efficacy of using ISCO's cells to improve healing after corneal surgery, and could result in the first FDA approved use of human cells produced by ISCO.
Jeffrey Janus, President of ISCO and CEO of Lifeline, noted that "The cells used in these trials are derived from donated human tissue processed using proprietary techniques devised by ISCO's subsidiary, Lifeline Cell Technology. However, ISCO's parthenogenic stem cells can also produce human corneal cells. Corneal cells derived from ISCO's parthenogenetic stem cells may provide a consistent and reliable source of corneal cells that could eliminate entirely the need for donated human tissues."
This work is being done in collaboration with Dr. Chen, who has developed the cell transfer technology. Dr. Chen is an eye surgeon at North County Laser Eye Associates, and he is on staff at Scripps Memorial La Jolla and Scripps Encinitas Hospitals.
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, CEO
760-940-6383
kaldrich@intlstemcell.com
or
Jeffrey Janus, President
760-940-6383
jjanus@intlstemcell.com
or
The Investor Relations Group
212-825-3210
Investor Relations:
Adam S. Holdsworth
aholdsworth@investorrelationsgroup.com
or
Media Relations:
Laura Colontrelle
lcolontrelle@investorrelationsgroup.com
Wednesday, May 27, 2009
Friday, May 22, 2009
Kenneth Aldrich, CEO of International Stem Cell Corporation, Addresses Some Questions Regarding Letter in Response to NIH Proposed Guidelines
In light of recent comments made by International Stem Cell in response to the NIH proposed Guidelines, I have been asked a lot of questions. Let me try to answer a few of the most common ones.
Q: Will the proposed guidelines hurt International Stem Cell unless they are revised?
A: No. They will be an inconvenience and perhaps force us to accept funding from foreign instead of US sources, but will not change the fundamental prospects of our company at all. We have been operating under the same kind of restrictions since the founding of our company and can continue to do so. NIH funding is of far more importance to academic researchers than to companies and a change specifically permitting Federal funding for Parthenogenesis research would enable more researchers in the US to use our cells. That would enable us perhaps to do more of our work here at home, but we truly are an international company and expect to be able to obtain the kind of funded research and researchers even if the proposed rules are not changed. However, we would greatly prefer to develop our technology with US based scientists in US universities if possible.
Q: Why then are you so opposed to the present proposed Guidelines?
A: The present proposals specifically exclude the use of Parthenogenesis (our technology) and SCNT (technology that we have licensed but do not currently use). Both of these are potentially very valuable sources of cells for the treatment of human diseases and can do things that can't be done with Embryonic stem cells or the iPS cells that are derived from genetically re-programmed human tissue. For example, parthenogenetic stem cells can be matched to the immune systems of millions of individuals, thus allowing the efficient creation of true stem cell banks for the population. Different stem cell technologies increase the potential for new medical breakthroughs and we believe that parthenogenesis is the strongest technology with the most medical potential. If the US government restricts the kind of technology it will support, whether because of politics or ignorance of the facts, it could deprive millions of people of the benefit of cures that might otherwise have been discovered.
Q: Why do you think the NIH has restricted its funding in these Guidelines?
A: I believe there are several issues, but none of them apply for Parthenogenesis. The NIH does not want federal money spent to derive human embryos for research use only. This does not apply for Parthenogenesis, because Parthenogenesis requires unfertilized human eggs – not fertilized human embryos. We believe this places Parthenogenesis on higher ethical ground. In addition, all of our Parthenogenetic lines have been created by women who entered IVF clinics with the intent of undergoing in-vitro fertilization (IVF), not the intent of creating stem cell lines.
I can only speculate, but strongly suspect that an additional reason may be a fear that somehow these technologies will lead to the need for thousands of human eggs and that women donors will be abused or taken advantage of to obtain such eggs for research. Nothing could be farther from the truth. The reality is that Parthenogenetic stem cells are derived from the excess eggs that fertilization clinics will eventually throw away. The only relevant difference between how stem cells are created through Parthenogenesis and how embryonic stem cells are created is whether or not the eggs are fertilized before being used as a source of stem cells. That has no impact on the donor at all. She produces the same number of eggs in the same way and only the excess are used for research, all under the same kinds of consent regulations. In addition, Parthenogenesis is an efficient process and does not require large numbers of eggs to produce a stem cell line. In fact, because Parthenogenesis can create a single line from a single donor that can be immune-matched to millions of individuals from multiple racial groups, once a bank of these lines is created, the need to obtain more human eggs will be greatly diminished or eliminated.
I hope these comments will clear up some of the mystery.
Sincerely,
Kenneth Aldrich
Chairman & CEO
International Stem Cell Corporation (ISCO.OB)
760-940-6383 (corporate office)
310-454-3055 (direct line)
310-593-1180 (mobile)
kaldrich@intlstemcell.com
www.internationalstemcell.com
Q: Will the proposed guidelines hurt International Stem Cell unless they are revised?
A: No. They will be an inconvenience and perhaps force us to accept funding from foreign instead of US sources, but will not change the fundamental prospects of our company at all. We have been operating under the same kind of restrictions since the founding of our company and can continue to do so. NIH funding is of far more importance to academic researchers than to companies and a change specifically permitting Federal funding for Parthenogenesis research would enable more researchers in the US to use our cells. That would enable us perhaps to do more of our work here at home, but we truly are an international company and expect to be able to obtain the kind of funded research and researchers even if the proposed rules are not changed. However, we would greatly prefer to develop our technology with US based scientists in US universities if possible.
Q: Why then are you so opposed to the present proposed Guidelines?
A: The present proposals specifically exclude the use of Parthenogenesis (our technology) and SCNT (technology that we have licensed but do not currently use). Both of these are potentially very valuable sources of cells for the treatment of human diseases and can do things that can't be done with Embryonic stem cells or the iPS cells that are derived from genetically re-programmed human tissue. For example, parthenogenetic stem cells can be matched to the immune systems of millions of individuals, thus allowing the efficient creation of true stem cell banks for the population. Different stem cell technologies increase the potential for new medical breakthroughs and we believe that parthenogenesis is the strongest technology with the most medical potential. If the US government restricts the kind of technology it will support, whether because of politics or ignorance of the facts, it could deprive millions of people of the benefit of cures that might otherwise have been discovered.
Q: Why do you think the NIH has restricted its funding in these Guidelines?
A: I believe there are several issues, but none of them apply for Parthenogenesis. The NIH does not want federal money spent to derive human embryos for research use only. This does not apply for Parthenogenesis, because Parthenogenesis requires unfertilized human eggs – not fertilized human embryos. We believe this places Parthenogenesis on higher ethical ground. In addition, all of our Parthenogenetic lines have been created by women who entered IVF clinics with the intent of undergoing in-vitro fertilization (IVF), not the intent of creating stem cell lines.
I can only speculate, but strongly suspect that an additional reason may be a fear that somehow these technologies will lead to the need for thousands of human eggs and that women donors will be abused or taken advantage of to obtain such eggs for research. Nothing could be farther from the truth. The reality is that Parthenogenetic stem cells are derived from the excess eggs that fertilization clinics will eventually throw away. The only relevant difference between how stem cells are created through Parthenogenesis and how embryonic stem cells are created is whether or not the eggs are fertilized before being used as a source of stem cells. That has no impact on the donor at all. She produces the same number of eggs in the same way and only the excess are used for research, all under the same kinds of consent regulations. In addition, Parthenogenesis is an efficient process and does not require large numbers of eggs to produce a stem cell line. In fact, because Parthenogenesis can create a single line from a single donor that can be immune-matched to millions of individuals from multiple racial groups, once a bank of these lines is created, the need to obtain more human eggs will be greatly diminished or eliminated.
I hope these comments will clear up some of the mystery.
Sincerely,
Kenneth Aldrich
Chairman & CEO
International Stem Cell Corporation (ISCO.OB)
760-940-6383 (corporate office)
310-454-3055 (direct line)
310-593-1180 (mobile)
kaldrich@intlstemcell.com
www.internationalstemcell.com
Tuesday, May 19, 2009
International Stem Cell Corporation Provides Comments on National Institutes of Health's Proposed Stem Cell Research Guidelines
International Stem Cell Corporation (OTCBB:ISCO) (www.intlstemcell.com), the company which pioneered the creation of human stem cells from unfertilized eggs (called "parthenogenetic stem cells"), provides the following comments regarding draft stem cell research guidelines issued by the National Institutes of Health (NIH) on April 17, 2009.
ISCO is surprised and disappointed that NIH draft guidelines favor federal financing for the study of embryonic stem cells, including those derived from surplus viable human embryos created for reproductive purposes and stored at fertility clinics, while denying government funds for the study of similar stem cells derived using other methods. These methods include parthenogenesis, which does not require the use or destruction of viable human embryos.
The important issues ISCO hopes the NIH will consider from a scientific, ethical, and competitive perspective prior to finalizing its human stem cell research guidelines include the following:
The draft guidelines effectively turn upside down an important ethical issue. The current proposal approves government funding for the study of stem cells derived from the destruction of viable human embryos while prohibiting funding for parthenogenesis, which does not destroy viable human embryos. In fact, the research use of ISCO's parthenogenetic stem cells has been approved by three independent Embryonic Stem Cell Research Oversight committees in the U.S. and by the California Institute for Regenerative Medicine. Parthenogenetic stem cells have also been approved for use in Germany, where the restrictions on embryonic stem cell research were even stronger than they were in the U.S. under the Bush administration.
Restricting U.S. funding to limited types of stem cells will limit opportunities for U.S. researchers and potentially lead to lost jobs and higher costs for American health care. Parthenogenetic stem cells are unique models for the study of immune rejection and DNA expression patterns. Another technology called "SCNT," excluded under the NIH draft guidelines and not pursued by ISCO, may also create stem cell lines useful in the study genetic diseases such as Parkinson's disease. U.S. companies developing parthenogenesis and SCNT technologies are receiving funding offers from the governments of Korea, India, and China. Without access to federal funding here in the U.S., technologies could migrate to other countries. When disease cures are ultimately developed and sought by the U.S. population, those cost-savings technologies and jobs will be located outside the U.S.
Fears exist that the study of certain types of stem cells will lead to women being exploited for their eggs, this fear is not applicable to parthenogenesis. A relatively small number of parthenogenetic stem cell lines stored in an "immune-matched parthenogenetic stem cell bank" could become a valuable resource from which therapeutic cells could be derived to treat large segments of the population. This level of efficiency is simply not available with any other source of stem cells. As a result, the total number of eggs ultimately needed to treat the population might be far fewer than if embryonic stem cells derived from fertility clinics were the only option available.
The proposed guidelines would create a de-facto monopoly on the economic benefits of stem cell research for two organizations that control most of the current patents for embryonic stem cells. At present, no one can produce cells from embryonic stem cells for human therapy in the U.S. without a license from one of these two organizations. Denying government funds for the study of similar cells derived using other methods limits competition in the licensing of patents. This will likely result in cures that are more expensive, take much longer to create, and/or be produced outside the U.S.
"Given the Obama Administration's commitment to the pursuit of objective scientific advances vs. rigid adherence to fixed political ideologies, we find the proposed NIH stem cell research guidelines vexing and all too narrowly focused," says International Stem Cell Corporation Chairman and CEO Kenneth Aldrich. "We believe these guidelines offer a strong opportunity to better educate the public about alternative stem cell research methods that exist beyond embryonic stem cells and hope that, upon further investigation and consideration, the NIH guidelines will be revised to take these worthy alternative methods into account. We appreciate this opportunity to make our comments public, make ourselves available to the Institute for consultation on issues relating to stem cell research, and look forward to a rigorous review process prior to the finalization of the Institute's guidelines."
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, CEO
kaldrich@intlstemcell.com
760-940-6383
or
Jeffrey Janus, President
jjanus@intlstemcell.com
760-940-6383
or
The Investor Relations Group
212-825-3210
Investor Relations:
Adam S. Holdsworth
aholdsworth@investorrelationsgroup.com
or
Media Relations:
Laura Colontrelle
lcolontrelle@investorrelationsgroup.com
ISCO is surprised and disappointed that NIH draft guidelines favor federal financing for the study of embryonic stem cells, including those derived from surplus viable human embryos created for reproductive purposes and stored at fertility clinics, while denying government funds for the study of similar stem cells derived using other methods. These methods include parthenogenesis, which does not require the use or destruction of viable human embryos.
The important issues ISCO hopes the NIH will consider from a scientific, ethical, and competitive perspective prior to finalizing its human stem cell research guidelines include the following:
The draft guidelines effectively turn upside down an important ethical issue. The current proposal approves government funding for the study of stem cells derived from the destruction of viable human embryos while prohibiting funding for parthenogenesis, which does not destroy viable human embryos. In fact, the research use of ISCO's parthenogenetic stem cells has been approved by three independent Embryonic Stem Cell Research Oversight committees in the U.S. and by the California Institute for Regenerative Medicine. Parthenogenetic stem cells have also been approved for use in Germany, where the restrictions on embryonic stem cell research were even stronger than they were in the U.S. under the Bush administration.
Restricting U.S. funding to limited types of stem cells will limit opportunities for U.S. researchers and potentially lead to lost jobs and higher costs for American health care. Parthenogenetic stem cells are unique models for the study of immune rejection and DNA expression patterns. Another technology called "SCNT," excluded under the NIH draft guidelines and not pursued by ISCO, may also create stem cell lines useful in the study genetic diseases such as Parkinson's disease. U.S. companies developing parthenogenesis and SCNT technologies are receiving funding offers from the governments of Korea, India, and China. Without access to federal funding here in the U.S., technologies could migrate to other countries. When disease cures are ultimately developed and sought by the U.S. population, those cost-savings technologies and jobs will be located outside the U.S.
Fears exist that the study of certain types of stem cells will lead to women being exploited for their eggs, this fear is not applicable to parthenogenesis. A relatively small number of parthenogenetic stem cell lines stored in an "immune-matched parthenogenetic stem cell bank" could become a valuable resource from which therapeutic cells could be derived to treat large segments of the population. This level of efficiency is simply not available with any other source of stem cells. As a result, the total number of eggs ultimately needed to treat the population might be far fewer than if embryonic stem cells derived from fertility clinics were the only option available.
The proposed guidelines would create a de-facto monopoly on the economic benefits of stem cell research for two organizations that control most of the current patents for embryonic stem cells. At present, no one can produce cells from embryonic stem cells for human therapy in the U.S. without a license from one of these two organizations. Denying government funds for the study of similar cells derived using other methods limits competition in the licensing of patents. This will likely result in cures that are more expensive, take much longer to create, and/or be produced outside the U.S.
"Given the Obama Administration's commitment to the pursuit of objective scientific advances vs. rigid adherence to fixed political ideologies, we find the proposed NIH stem cell research guidelines vexing and all too narrowly focused," says International Stem Cell Corporation Chairman and CEO Kenneth Aldrich. "We believe these guidelines offer a strong opportunity to better educate the public about alternative stem cell research methods that exist beyond embryonic stem cells and hope that, upon further investigation and consideration, the NIH guidelines will be revised to take these worthy alternative methods into account. We appreciate this opportunity to make our comments public, make ourselves available to the Institute for consultation on issues relating to stem cell research, and look forward to a rigorous review process prior to the finalization of the Institute's guidelines."
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, CEO
kaldrich@intlstemcell.com
760-940-6383
or
Jeffrey Janus, President
jjanus@intlstemcell.com
760-940-6383
or
The Investor Relations Group
212-825-3210
Investor Relations:
Adam S. Holdsworth
aholdsworth@investorrelationsgroup.com
or
Media Relations:
Laura Colontrelle
lcolontrelle@investorrelationsgroup.com
Friday, May 8, 2009
International Stem Cell Corporation's Letter to the NIH
International Stem Cell Corporation respectfully requests that the NIH grant to researchers using stem cells created through parthenogenesis the same access to Federal funding as is provided for embryonic stem cells.
The fundamental basis for our request is that, although parthenogenetic stem cells are derived from unfertilized human eggs, not human embryos, the currently proposed Guidelines are likely to be interpreted to prohibit funding for such lines, even though the donation procedures otherwise meet all the requirements being imposed on embryonic stem cells.
Both types of cell lines are derived from human eggs obtained in the normal process of in-vitro fertilization. The difference is that making embryonic stem cells requires the creation (by fertilization) and subsequent destruction of viable human embryos, while parthenogenesis requires only unfertilized eggs from which no viable embryo is ever created or destroyed.
If parthenogenesis is denied funding, the source of stem cell lines that raises the fewest ethical issues (parthenogenesis) would be denied funding while the source that raises the most (embryonic stem cells) would receive Federal funding. Of possibly greater importance is the fact that while the stem cell industry is still in its infancy, with none of the hopes for embryonic, iPS or any other cell types yet verified in the clinic, the arbitrary exclusion from funding of an alternate technology that might offer new solutions could result in wasted opportunities to save human lives.
Both types of cell lines are obtained from eggs donated by women who have already made the decision to seek in-vitro fertilization. The primary motives of the donors are the same, and the consent procedures and donor protections are also the same. No public purpose is served by excluding parthenogenic stem cell lines from federal funding simply because the donated eggs were not fertilized in the process of creating stem cells.
Based on these distinctions, we propose that so long as the primary motivation of the donors is the same and the same ethical and informed consent standards are applied, whether or not excess eggs from IVF clinics are fertilized or not fertilized should not affect whether they may be used for federally sponsored research.
We suggest that the following factors also be considered in determining the final form of the Guidelines:
· The fear that viable human embryos are being created solely for research purposes or that women are being exploited for their eggs simply does not apply to parthenogenesis. First, as mentioned above, parthenogenesis does not lead to the creation of viable human embryos. No potential human life is destroyed. Second, the existing parthenogenetic stem cell lines were created from eggs donated by women with the primary intent of participating in IVF, and the same standard can and should be maintained for future lines. Whether excess eggs are fertilized or unfertilized does not pose any additional risk to the donors. In fact, every woman who has ever donated eggs to our company that led to the creation of parthenogenetic stem cell lines has had a successful pregnancy.
· Parthenogenesis may actually reduce the number of donations required because it allows for the creation of single lines of pluripotent stem cells that can be immune-matched (similar to how bone marrow is matched between donors and recipients) to large population groups. In other words, once a stem cell bank of perhaps 50 to 100 parthenogenetic stem cell lines is established, the need to continuously seek more eggs to match a population group may be greatly reduced or eliminated. The resulting immune-matched stem cell bank would become a valuable medical resource for regenerative medicine that is not available from any other source of cells. As a result, the total number of unfertilized eggs needed to create such a stem cell bank may be far fewer than the number of viable human embryos needed under the currently proposed Guidelines.
· The proposed Guidelines could create an unintended de-facto monopoly on the economic benefits of stem cell research. Today, a small number of organizations and companies control most of the current patents for embryonic cells. If cells subject to those patents are the only cells that can receive Federal funding, there will be no competition in the licensing of patents and no incentive for lower cost licensing of those rights. This could easily increase the cost of cures to the patient or repress innovation. Allowing alternative methods of creating stem cells, so long as they comply with the ethical rules of informed consent and utilize only appropriate donors, could avoid those problems.
· Blocking access to Federal funding for alternative methods of stem cell research could limit research opportunities for NIH-based scientists and also drive research and jobs overseas. Due to their unique characteristics, parthenogenetic stem cells offer a valuable research model to study immune response, cell differentiation and epigenetic processes such as imprinting, methylation, reprogramming and maternal effects. Under the proposed Guidelines, this research model would not be available to NIH-funded researchers in the U.S. U.S. companies now developing parthenogenesis technology are already receiving offers from various foreign countries such as Korea, India, and China to provide funding and move research to those countries. Without access to federal dollars, there will be no practical imperative to prevent U.S. companies from locating overseas. If disease cures are then developed outside the U.S., the potential profits and jobs will go elsewhere and the cures developed could come back to the U.S. at a much higher price.
We appreciate this opportunity to make our comments public, make ourselves available to the Institute for consultation on issues relating to stem cell research, and look forward to a rigorous review process prior to the finalization of the Institute’s guidelines.
Sincerely,
Kenneth C. Aldrich
Chairman, CEO, and Co-Founder
International Stem Cell Corporation
The fundamental basis for our request is that, although parthenogenetic stem cells are derived from unfertilized human eggs, not human embryos, the currently proposed Guidelines are likely to be interpreted to prohibit funding for such lines, even though the donation procedures otherwise meet all the requirements being imposed on embryonic stem cells.
Both types of cell lines are derived from human eggs obtained in the normal process of in-vitro fertilization. The difference is that making embryonic stem cells requires the creation (by fertilization) and subsequent destruction of viable human embryos, while parthenogenesis requires only unfertilized eggs from which no viable embryo is ever created or destroyed.
If parthenogenesis is denied funding, the source of stem cell lines that raises the fewest ethical issues (parthenogenesis) would be denied funding while the source that raises the most (embryonic stem cells) would receive Federal funding. Of possibly greater importance is the fact that while the stem cell industry is still in its infancy, with none of the hopes for embryonic, iPS or any other cell types yet verified in the clinic, the arbitrary exclusion from funding of an alternate technology that might offer new solutions could result in wasted opportunities to save human lives.
Both types of cell lines are obtained from eggs donated by women who have already made the decision to seek in-vitro fertilization. The primary motives of the donors are the same, and the consent procedures and donor protections are also the same. No public purpose is served by excluding parthenogenic stem cell lines from federal funding simply because the donated eggs were not fertilized in the process of creating stem cells.
Based on these distinctions, we propose that so long as the primary motivation of the donors is the same and the same ethical and informed consent standards are applied, whether or not excess eggs from IVF clinics are fertilized or not fertilized should not affect whether they may be used for federally sponsored research.
We suggest that the following factors also be considered in determining the final form of the Guidelines:
· The fear that viable human embryos are being created solely for research purposes or that women are being exploited for their eggs simply does not apply to parthenogenesis. First, as mentioned above, parthenogenesis does not lead to the creation of viable human embryos. No potential human life is destroyed. Second, the existing parthenogenetic stem cell lines were created from eggs donated by women with the primary intent of participating in IVF, and the same standard can and should be maintained for future lines. Whether excess eggs are fertilized or unfertilized does not pose any additional risk to the donors. In fact, every woman who has ever donated eggs to our company that led to the creation of parthenogenetic stem cell lines has had a successful pregnancy.
· Parthenogenesis may actually reduce the number of donations required because it allows for the creation of single lines of pluripotent stem cells that can be immune-matched (similar to how bone marrow is matched between donors and recipients) to large population groups. In other words, once a stem cell bank of perhaps 50 to 100 parthenogenetic stem cell lines is established, the need to continuously seek more eggs to match a population group may be greatly reduced or eliminated. The resulting immune-matched stem cell bank would become a valuable medical resource for regenerative medicine that is not available from any other source of cells. As a result, the total number of unfertilized eggs needed to create such a stem cell bank may be far fewer than the number of viable human embryos needed under the currently proposed Guidelines.
· The proposed Guidelines could create an unintended de-facto monopoly on the economic benefits of stem cell research. Today, a small number of organizations and companies control most of the current patents for embryonic cells. If cells subject to those patents are the only cells that can receive Federal funding, there will be no competition in the licensing of patents and no incentive for lower cost licensing of those rights. This could easily increase the cost of cures to the patient or repress innovation. Allowing alternative methods of creating stem cells, so long as they comply with the ethical rules of informed consent and utilize only appropriate donors, could avoid those problems.
· Blocking access to Federal funding for alternative methods of stem cell research could limit research opportunities for NIH-based scientists and also drive research and jobs overseas. Due to their unique characteristics, parthenogenetic stem cells offer a valuable research model to study immune response, cell differentiation and epigenetic processes such as imprinting, methylation, reprogramming and maternal effects. Under the proposed Guidelines, this research model would not be available to NIH-funded researchers in the U.S. U.S. companies now developing parthenogenesis technology are already receiving offers from various foreign countries such as Korea, India, and China to provide funding and move research to those countries. Without access to federal dollars, there will be no practical imperative to prevent U.S. companies from locating overseas. If disease cures are then developed outside the U.S., the potential profits and jobs will go elsewhere and the cures developed could come back to the U.S. at a much higher price.
We appreciate this opportunity to make our comments public, make ourselves available to the Institute for consultation on issues relating to stem cell research, and look forward to a rigorous review process prior to the finalization of the Institute’s guidelines.
Sincerely,
Kenneth C. Aldrich
Chairman, CEO, and Co-Founder
International Stem Cell Corporation
Thursday, May 7, 2009
Attend Live Webcast on May 12th "Beyond Embryonic Stem Cells" with Kenneth Aldrich, CEO of International Stem Cell Corporation
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Kenneth Aldrich, International Stem Cell Corporation's CEO and Chairman, to Present Webcast at the Stem Cell Summit, May 12, 2009.
The Stem Cell Summit will host numerous state and country webcast presentations showcasing their research and investment in this burgeoning field, along with displays by leading companies and institutions all contributing to this growth.
Title: Beyond Embryonic Stem Cells
Presenter: Kenneth Aldrich, ISCO CEO & Chairman
Date: Tuesday, May 12, 2009
Scheduled Time: 9:00 – 9:45 a.m. Pacific Time
Link to register for the free webcast: http://www.brighttalk.com/webcasts/3928/attend.
With the announcement of a pending change in federal rules governing stem cell research, embryonic stem cells have dominated the news in recent days. However, there are other methods of producing pluripotent stem cells that provide exciting alternatives and opportunities to advance human therapy that go beyond what is likely from embryonic stem cells. These include Parthenogenic Stems Cells (made without the use or destruction of human embryos) that may offer a solution to the problem of immune rejection; Induced Pluripotent Stem Cells made from skin or other tissue, including possibly tissue from the patient; and Somatic Cell Nuclear Transfer, which has been largely forgotten, but offers very interesting possibilities. This presentation will discuss these various methods and their advantages and disadvantages as compared to each other and embryonic stem cells. To register (by setting up a free account) for the webcast please click on the following link:
http://www.brighttalk.com/webcasts/3928/attend.
The webcast is free for registered participants and can be viewed live or later on-demand.
Kenneth Aldrich, International Stem Cell Corporation's CEO and Chairman, to Present Webcast at the Stem Cell Summit, May 12, 2009.
The Stem Cell Summit will host numerous state and country webcast presentations showcasing their research and investment in this burgeoning field, along with displays by leading companies and institutions all contributing to this growth.
Title: Beyond Embryonic Stem Cells
Presenter: Kenneth Aldrich, ISCO CEO & Chairman
Date: Tuesday, May 12, 2009
Scheduled Time: 9:00 – 9:45 a.m. Pacific Time
Link to register for the free webcast: http://www.brighttalk.com/webcasts/3928/attend.
With the announcement of a pending change in federal rules governing stem cell research, embryonic stem cells have dominated the news in recent days. However, there are other methods of producing pluripotent stem cells that provide exciting alternatives and opportunities to advance human therapy that go beyond what is likely from embryonic stem cells. These include Parthenogenic Stems Cells (made without the use or destruction of human embryos) that may offer a solution to the problem of immune rejection; Induced Pluripotent Stem Cells made from skin or other tissue, including possibly tissue from the patient; and Somatic Cell Nuclear Transfer, which has been largely forgotten, but offers very interesting possibilities. This presentation will discuss these various methods and their advantages and disadvantages as compared to each other and embryonic stem cells. To register (by setting up a free account) for the webcast please click on the following link:
http://www.brighttalk.com/webcasts/3928/attend.
The webcast is free for registered participants and can be viewed live or later on-demand.
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