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