Researchers at the Hadassah University Medical Organization in Jerusalem have produced, for the first time, under Good Manufacturing Practices (GMP) conditions, lines of human embryonic stem cells (hESCs) for transplantation that are free of animal components.
As the researchers explain: "Most of the reported hESC lines worldwide are not ideal for use in clinical trials. They were developed without adherence to Good Manufacturing Practices (GMPs), using animal-derived research-grade reagents, which may infect the cells with animal pathogens. Moreover, many cell lines were derived and cultured on animal feeder cells, which may contaminate the hESCs by nonhuman sialic acid Neu5Gc molecules, which can elicit immune rejection after transplantation."
Human embryonic stem cells can differentiate and mature into any cell type in the human body. This gives them the potential to serve as an infinite source of cells for transplantation to mitigate degenerative diseases such as diabetes, heart failure, and Parkinson's.
The new stem cell lines were produced from six-day-old embryos donated by couples who had completed their in vitro fertilization treatments. After reviewing the ethical procedures involved in the embryo donation and the production of the stem cells, both Israel's Ministry of Health and the United States National Institutes of Health (NIH) found them appropriate and granted ethical approval. The NIH approval allows researchers in the United States to use these new cell lines in studies funded by the federal government.
Prof. Benjamin Reubinoff, Director of the Sidney and Judy Swartz Human Embryonic Stem Cell Research Center, headed the study, which is highlighted in the June 20, 2012 issue of PLoS ONE, an international, peer-reviewed, open-access, online publication of the Public Library of Science. The cell lines have already been provided to two Israeli companies: Cell Cure Neurosciences Ltd.--to develop transplantation treatment for Age-Related Macular Degeneration--and Kadimastem Ltd. for diabetes. Hadasit, Hadassah's technology transfer company, commercialized the new technology by awarding licenses to the two companies and is overseeing the translational process.
The study was partially conducted by the Bereshit Consortium, a group of companies and academic institutions funded by Israel's Ministry of Industry, Trade and Labor to advance the development of stem cell transplantations.