International Stem Cell (ISCO) entered into a strategic alliance with The Automation Partnership (TAP) to automate and scale up the production of stem cell-derived human corneal tissue. The collaboration has been formed to create instrumentation for ISCO, its partners, and its affiliates to produce development and commercial volumes of donor tissue for cornea transplantation. The organizations believe that this will reduce the use of animals and animal eyes in safety testing of drugs, chemicals, and consumer products.
Global efforts are under way to transition from the use of live animals and excised animal eyes, ISCO and TAP point out. For example, they note, Europe’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) estimates a need to spend €270 million, or about $333.76 million, and use 160,000 animals for eye-safety testing alone to catch up with the backlog of insufficiently tested agents. In the U.S. the NIH and EPA have launched a five-year program dedicated to finding new, nonanimal technologies for toxicity testing of chemical compounds, the organizations add.
ISCO has discovered and filed for patents on a cell culture process for the synthesis of standardized, human corneal tissue using stem cells. Histology, permeability, and optical testing has demonstrated compatibility with natural corneas. Efforts are ongoing to further characterize this tissue and to standardize and scale up its synthesis. Automation is necessary to produce sufficient, reproducible tissue for development and commercialization of the therapeutic and toxicity testing applications.
“Given the substantial unmet therapeutic and toxicology testing needs for human corneal tissue, ISCO has embarked on a focused effort to advance this technology with international investors, eye clinics, and development and commercialization partners,” says Brian Lundstrom, ISCO’s president.
ISCO’s core technology is based on parthenogenesis, which results in the creation of human pluripotent stem cells from unfertilized oocytes. ISCO says that it has created a parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages, and racial groups. ISCO also aims to create a stem cell bank called UniStemCell™.