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.

Kenneth C. Aldrich
Chairman, CEO, and Co-Founder
International Stem Cell Corporation

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