Newswise — Last week, the Food and Drug Administration (FDA) cleared the way for the first human trials of human embryonic stem cell research, authorizing Geron Corporation to test whether cells are safe for use in spinal injury patients.
"The FDA's decision to approve human clinical trials of stem cells is wonderful news for the medical and scientific communities, as it is a significant acknowledgement that the FDA is growing more comfortable with stem cell use," says Kenneth C. Aldrich, Chairman, CEO, and Co-Founder of International Stem Cell Corporation (ISCO), a California-based biotechnology company focused on developing therapeutic and research products. "That said, the Geron approval is only half the story. Simply put: not all stem cells are created equal, and there are any number of controversies and issues that continue to swirl around stem cell research."
Apart from Geron, ISCO owns the only other source of pluripotent stem cells suitable for transplants today, one that has distinct competitive advantages. First, ISCO's stem cell lines can be generated without the use of fertilized embryos: through a patented procedure known as parthenogenesis, an unfertilized human egg, or oocyte, can be chemically induced to form a tiny cluster of cells from which a stem cell line can be created, thereby solving the ethical problem surrounding the use of fertilized human embryos. Second, ISCO stem cell lines also address immune rejection issues: the company's stem cell lines can match the immune systems of several hundred million people and ISCO is in the early stages of creating a "bank" of stem cells that can be matched to huge population segments.
Recently, the company reported that by using its proprietary technique, cells from a single donor could be matched to general genetic patterns, known as "human leukocyte antigens" (HLAs), of hundreds of millions of patients. Since a single line of these cells may eliminate immune rejection issues in large segments of the population, parthenogenetic stem cells could be enormously valuable as a treatment of choice for diseases including diabetes, liver disease, heart disease, and macular degeneration. Based on this technology, the company has initiated an ambitious program for developing the world's first human stem cell bank to serve the need for stem cell-based treatments in the general population.
As chance would have it, ISCO has used the same research lab (Hans Kierstead's lab at UC Irvine) for their work in Macular Degeneration that Geron used to produce the cells for its trials and have demonstrated in that laboratory that their cells can also be differentiated into human cells suitable for transplant.
"ISCO's stem cell lines behave just like embryonic stem cells but with the added advantages of solving certain moral dilemmas and addressing patient immune rejection issues," says Mr. Aldrich. "The FDA's approval of Geron clinical trials marks an enormous step forward for the field of stem cell research and clears the way toward ISCO to hopefully begin human trials by the end of the year."
For those covering this news, International Stem Cell Corporation makes available company Chairman, CEO, and Co-Founder Kenneth C. Aldrich to discuss a variety of topics including:
"¢ Why is embryonic stem cell research such a controversial practice?"¢ What are the scientific and medical industry implications of the FDA's recent approval of Geron Corporation clinical trials?"¢ What is parthenogenesis, and why might this process be preferred to embryonic stem cell research?"¢ How does parthenogenesis solve ethical and immune rejection issues surrounding stem cell research?"¢ What are "human leukocyte antigens" and how do they relate to immune rejection issues?"¢ What are potential scientific and medical applications for stem cell research?
Expert Biography " Kenneth C. Aldrich, Chairman, CEO, and Co-Founder, International Stem Cell CorporationKenneth C. Aldrich has been active in venture capital investing and private equity since 1975. He is Co-founder and Chairman of International Stem Cell Corporation (ISCO), and an active member of Tech Coast Angels. Throughout his career, he has provided early-stage funding and management for a variety of biomedical and technology start-ups, including WaveTec Vision Systems, an ophthalmic device company (as a Director and co-founder), Neurion Pharmaceuticals, Inc., a drug discovery and evaluation company (as a Director and co-founder), and Orfid Corporation, a developer of organic transistors (as a founder and financial advisor). He is also a director of Green Dot Corporation, the world's largest issuer of prepaid debit cards. Mr. Aldrich holds degrees, with honors, from both Harvard University and Harvard Law School.
About International Stem Cell CorporationInternational Stem Cell Corporation (ISCO) 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 also have created the first Parthenogenetic homozygous stem cell line (phSC-Hhom-4) that can be a source of therapeutic cells that will not be immune rejected after transplantation into 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.
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