International Stem Cell Corporation (OTCBB:ISCO), www.internationalstemcell.com, has now enrolled the first U.S.-based donor in its program to establish a bank of clinical-grade human parthenogenetic stem cells (hpSCs) capable of being immune-matched to millions of patients.
Dr. Simon Craw, Vice President of ISCO with primary responsibility for building its UniStemCell Bank, said, "Enrolling our first donor is a key milestone towards our goal of creating a bank of clinical-grade pluripotent human stem cells with the ability to immune-match millions of patients. It is extremely exciting to start this new phase of development, and I look forward to making new clinical-grade hpSC lines available to medical researchers around the world."
ISCO maintains the world's largest collection of research-grade human parthenogenetic stem cell (hpSC) lines which it uses along with its partners and collaborators to investigate cellular therapies for a number of incurable human diseases.
ISCO previously announced it had successfully obtained the necessary regulatory approvals for obtaining human oocytes, including Institutional Review Board (IRB) approval and Stem Cell Research Oversight (SCRO) committee approval. Today's announcement marks the next phase of development as the Company is now positioned to begin producing new clinical-grade hpSC lines.
These new cell lines will be ISCO's first hpSCs to be produced in the United States in accordance with Good Manufacturing Practice (cGMP) specifications. The new cGMP hpSC lines will be uniquely valuable in therapeutic research and clinical development as cells or tissue derived from such cells can be used in human clinical trials.
ISCO's scientific discoveries have resulted in the development of a unique new type of pluripotent stem cells that possess a number of distinct advantages over other types of human pluripotent stem cells. ISCO uses unfertilized oocytes to create human "parthenogenetic" stem cells. Like human embryonic stem cells (hESCs), hpSCs are pluripotent, i.e. they have the capacity to become almost any cell type in the body, yet avoid ethical issues associated with use or destruction of viable human embryos. Unlike hESCs, hpSCs can be created in a form such that they can be immunologically matched to millions of individuals.
International Stem Cell Corporation