International Stem Cell Corp. reported some ground-breaking news recently, showcasing the progress the company has made towards clinical-grade, applied stem cell therapy, with the announcement that the R&D team has successfully created the first human, clinical-grade stem cell lines able to immune-match millions of people and thus sharply reduce rejection by the individual's immune system.
This revolutionary breakthrough is an extension of ISCO's established research-grade parthenogenetic stem cell (hpSC) technology, proprietarily engineered and designed from the ground up to align perfectly with FDA regulations, as well as the Good Tissue Practice (GTP) and Good Manufacturing Practice (GMP) standards they helped create to ensure quality control for the clinical space. These new lines have been validated as HLA coding region-homozygous (simple gene profile in the areas which code for immune rejection) by independent third party testing, a feature which not only gives them a distinct clinical advantage due to patient-specific immune matching capability (huge reduction in rejection by the host immune system), but also further clearly sets the technology apart from embryonic stem cells.
An immune type contained within the company's existing hpSC lines affords potential to immune-match some 70M people and is the most common type in the entire Caucasian populace. Development of clinical grade lines from this rock-solid foundation is now enabling ISCO to transcend previous limitations and initiate U.S. clinical trials. Think about the impact of ISCO being able to supply the global medical community with a nearly limitless supply of viable, FDA-compliant stem cells which have this immune-matching capability, the upside to patients alone is enough to make headlines.
CEO of ISCO and Co-Chairman of the Board, Andrey Semechkin, PhD, was boldly confident about the success rate of the new stem cell lines to immune-match millions (the core technology is proven after all) and underscored how the GMP compliance opens access to a massive network of clinical pipelines. Safe, feature-rich cell and tissue development from this incredible technology platform should tear down several walls in the clinical arena, as the promise of commercial therapies from pluripotent human stem cells (from unfertilized eggs) now appears well within striking distance.
Being able to generate such highly-functional therapeutic cells, as well as downstream cell-based therapeutic research and cosmetic products (for the company's Lifeline Cell Technology and Lifeline Skin Care subsidiaries), puts ISCO in an extremely favorable position as this milestone breaks. Something detailed by Exec. VP of ISCO, Simon Craw, PhD., who went on to elaborate how the significance of this platform technology's development cannot be underestimated, both for the life science/medical community and for shareholders as well. Dr. Craw called it a critical milestone for ISCO on the road to becoming a clinical stage company and reaffirmed how the development shores up ISCO's broader leadership position in the stem cell technology field.
This new immune-matching marvel will add to the company's already impressive Stem Cell Bank, which is emerging as the first ever collection framework of non-embryonic, histocompatible human stem cells for the life science industry's most advanced work. We have here, in this technology, a framework to test therapies and from which to engineer them, that stands to change the face of medicine itself. This is one of the final hurdles to clear before the biotech company ISCO goes supernova and it will be quite interesting to see how clinical development advances in the coming months.
The potential impact for severe degenerative diseases of the eye, nervous system, and liver, where this technology has already proven itself clinically, but was not viable due to an inability to provide comprehensive immune-matching, is immense and the entire area now opens up like a vast new frontier. ISCO is already geared up to pioneer that land and has set out to stake claim to a lucrative, untrammeled territory, whose mastery should translate directly into substantial shareholder growth over the long-term.
For more information on International Stem Cell Corp., visit InternationalStemCell.com
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