International Stem Cell Corporation (OTCBB:ISCO), www.internationalstemcell.com, announced today the achievement of a major milestone in its efforts to establish a bank of immune-matched parthenogenetic stem cells in the United States by receiving the statutory approvals required to move forward with the next phase of its stem cell banking program.
An independent Stem Cell Research Oversight (SCRO) committee approved ISCO's program to obtain human oocytes (eggs) in California. The independent SCRO committee is responsible for reviewing the scientific rationale, ethics and compliance with State and Federal regulations and guidelines for studies involving human stem cells. This approval in combination with the earlier reported Institutional Review Board (IRB) clearance with regard to medical safety opens the way for ISCO's stem cell banking program to begin registering clinical investigators. ISCO's study is designed to produce new clinical-grade human parthenogenetic stem cell lines that can be immune matched to millions of individuals for use in the emerging field of regenerative medicine.
ISCO's breakthrough discoveries have resulted in unique stem cells carrying distinct advantages over other human pluripotent stem cells. ISCO uses unfertilized oocytes to create human "parthenogenetic" stem cells (hpSCs). 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.
Currently ISCO has a collection of ten hpSC lines that are shared with collaborators and used for research purposes. Although these ten stem cell lines conform to all relevant US standards, they were derived outside the United States. New cell lines created under this study will be ISCO's first hpSC to be produced in the United States. ISCO's scientists, leaders the field of creating therapeutic cells from hpSC, will work with these lines targeting new treatments for human diseases. The company will also share these cells with other scientists to further clinical research. ISCO intends to derive and store these cells at its Oceanside facilities, which are designed to create cells suitable for clinical use.
Simon Craw, PhD, says, "These approvals, combined with our technology, make the establishment of a bank of immune matched stem cells practical and allow for the possibility of cell-based therapy to be economic for millions of people. We believe we are one of the first commercial entities in the United States to have progressed to this point."
INTERNATIONAL STEM CELL CORPORATION