Tuesday, October 11, 2011

International Stem Cell Corporation's Ken Aldrich Comments on Recent News about SCNT - Somatic Cell Nuclear Transfer

Last week's newspapers carried the news of what was widely described as a significant “breakthrough” in stem cell science: the first successful human use of a technology known as Somatic Cell Nuclear Transfer (also referred to as SCNT).  This is essentially a variation on a process that was used some years ago to create a cloned sheep named Dolly.  Cloning has since been used commercially in various animal applications.

What is strange about the flurry of publicity about this discovery, however, is the almost total lack of commentary about a method of creating stem cells that has been available to researchers for almost half a decade, holds the same kind of promise as embryonic stem cells for providing cells for the treatment of almost any kind of degenerative disease, is free of ethical issues (including issues with egg donation), and can potentially make immune matched cells available to any patient anywhere in the world, on demand, at a far lower cost.

I am talking about human stem cells derived from a process called, “Parthenogenesis”, developed and first announced in 2007 by a company called International Stem Cell Corporation, whose discoveries were first published in the peer reviewed journal, Cloning and Stem Cells, edited by the scientist who first created “Dolly”, the first cloned animal. 

I realize that I could be accused of bias because I am one of the founders of International Stem Cell, but, in fact, our company also owns license rights to some of the key intellectual property that is required to create cells through SCNT technology and our scientists are very familiar with its promise and its limitations. As a result, International Stem Cell will benefit from the development of either technology, but it is important that the public and the scientific community be fully aware of all alternatives in the field of regenerative medicine, not just the ones that capture public imagination at any particular time.

For that reason, I would like to comment on Parthenogenesis and compare it to SCNT technology and the other options available today. The technology known as "Parthenogenesis" begins with human eggs that are created and used every day throughout the world for in-vitro fertilization (IVF). What is not generally known is that the IVF process can often result in the creation of far more unfertilized eggs than will ever be needed for fertility purposes. It is possible, with informed consent from the IVF patient, to hold back some unfertilized eggs for creation of parthenogenetic stem cells, all at no additional risk to the donor. 

Instead of wasting those eggs, what International Stem Cell does, with the full consent of the donors, is to save those eggs from the trash bin, induce them through a simple, but patented, process to create the small cluster of cells from which a stem cell line can be created that can be used for scientific research and the eventual treatment of patients with such diseases as Parkinson’s, Macular Degeneration, Liver Disease, Diabetes, and possibly many others.

What are critical to understand in thinking about Parthenogenetic stem cells are six things:
Like embryonic stem cells and SCNT cells, these cells can be converted into almost any cell in the human body and thus have enormous potential for human therapy.

Unlike embryonic stem cells, the human eggs used to create parthenogenetic stem cells are never fertilized and cannot become a human being. No viable embryo is ever harmed or destroyed.

Unlike SCNT cells, parthenogenetic stem cells require no genetic manipulation or insertion of foreign DNA.

No donor is every subjected to any additional physical risk beyond what she has already agreed to as part of the IVF procedure in which she elected to participate. In fact, all egg donors voluntarily participate through a very transparent, peer-reviewed, and medically supervised process.  Protocols are approved by Independent Review Boards (IRBs) to protect the safety of donors and by an independent Stem Cell Research Oversight (SCRO) committee to insure compliance with state laws and research ethics, regulations established by the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections, in addition to state-level requirements.

The cell lines that are produced from this method, unlike cell lines from embryonic stem cells or from SCNT, can potentially be matched to millions of people in the same way that an organ transplant is matched between donor and patient. In fact, by some estimates, as few as 100 parthenogenetic stem cell lines could provide immune-matched cells to over 50 percent of the world’s population, and could accelerate disease therapies and treatments for severe chronic conditions, including diabetes, spinal cord injuries, liver diseases, blinding diseases such as macular degeneration, and neural diseases such as Parkinson’s and Alzheimer’s.

The possibility of immune-matching to millions of persons can vastly reduce the potential costs relative to SCNT or embryonic stem cell technology, which create stem cell lines that can match only a few persons.

In summary, what we find particularly exciting about Parthenogenesis is that it addresses all the major issues of stem cell therapy. It is free from the traditional bioethical issues that have clouded federal policies towards stem cell research because parthenotes are derived from unfertilized eggs and cannot develop into human beings.  Parthenogenesis is not cloning, and it does not involve the creation or destruction of a viable human life.  Also, the creation of a parthenogenetic stem cell bank will not require a large number of human eggs and many individual donors, as has been a fear surrounding other stem cell approaches.  Parthenogenesis is at once effective and efficient, and one line of parthenogenetic stem cells can be used to create treatments for millions of persons.  This is not a situation where one line must be made for each patient treated.

To learn more about Parthenogenesis, visit www.internationalstemcell.com, or click on ISCO.OB at any financial web site for information about our company.

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