International Stem Cell Corp., a biotechnology company specializing in the therapeutic applications of human parthenogenetic stem cells (hpSCs), has achieved a critical milestone towards the clinical development of its non-embryonic stem cell therapy.
Through much dedication and hard work, the company's research and development team has created the world's first human clinical-grade stem cell lines that can be immune-match to millions of individuals. ISCO's existing research-grade parthenogenetic stem cell lines, one of which may be an immune-match to approximately 70 million people, are being used in pre-clinical development. ISCO is now in a position to conduct clinical trials in the United States.
"We've been working diligently for three years to perfect this technology, which was first developed by our scientific founder, Dr. Elena Revazova in Moscow, and I'm excited to report that we have been able to derive new stem cell lines in the United States under the US and California regulatory frameworks. I'm optimistic that the new parthenogenetic stem cell lines, by providing a potentially unlimited supply of cells and tissue for transplantation, will be of great benefit to the medical community and patients world-wide," stated Dr. Semechkin, CEO and Co-Chairman of the Board.
Created using ISCO's proprietary technology, the new stem cell lines represent the first of a new generation of clinical-grade human parthenogenetic stem cell (hpSC) lines created in the United States under US regulatory oversight and designed to meet FDA regulations. The US Food and Drug Administration developed Good Tissue Practice (GTP) and Good Manufacturing Practice (GMP) standards to ensure the safety of products developed for clinical use. Conforming to GMP is necessary to conduct clinical development programs.
Independent third-party testing has confirmed the new lines to be "homozygous" in the HLA coding regions. This means that they have a simple genetic profile in the critical areas of the DNA that code for immune rejection; a distinct clinical advantage over embryonic stem cells. The company anticipates the new lines to immune-match millions of individuals. They will be added to ISCO's existing bank and provide a platform from which to develop cells and tissue for clinical use.
"The importance of this breakthrough cannot be overstated," emphasized Dr. Craw, Executive Vice President of ISCO. "Expanding our collection is not only important for our therapeutic programs, but also further establishes our leadership position in human stem cell technology. Achieving this critical milestone moves us along the path to make the transition into a clinical stage company."
To learn more about ISCO and its superior stem cell technology, visit InternationalStemCell.com
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