International Stem Cell (ISCO) Announces Publication of Positive ISC-hpNSC Safety Data

October 5, 2016 8:37 AM EDT
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International Stem Cell Corporation (OTC: ISCO) announced that it has published the results of its preclinical safety studies. The data from a series of in vitro and in vivo preclinical studies show that the company's proprietary ISC-hpNSC® readily expandable neural stem cells are devoid of undifferentiated pluripotent stem cells and are safe for transplantation. The full manuscript titled, "Neural Stem Cell Tumorigenicity and Biodistribution Assessment for Phase I Clinical Trial in Parkinson’s Disease,” was published in the September 30 issue of Scientific Reports, a multidisciplinary journal from the publishers of Nature.

"The publication of the data in the peer-reviewed journal, Scientific Reports, is further support to the safety of ISCO’s Parkinson's disease studies. In the groundbreaking treatment, where human lives are involved, safety is of utmost importance, with no room for error,” said Russell Kern, Ph.D., ISCO's Executive Vice President and Chief Scientific Officer.

“The results from these safety studies show that the tumorigenic potential of the cGMP manufactured ISC-hpNSC® is negligible with no detectable undifferentiated pluripotent stem cells, providing additional assurance to their clinical translation,” commented Ibon Garitaonandia, Ph.D., ISCO’s Director of Translational Research.

One of the main concerns with stem cell treatment is that undifferentiated pluripotent stem cells have the potential to grow uncontrollably and cause tumors in the recipient’s body. This study not only validates the purity of the neural stem cells, but it also demonstrates that ISC-hpNSC® could be tolerated at very high doses in the brains of test animals, comparable to administering over two billion cells in humans. The safety studies were required by the US Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA) prior to conducting a Phase I clinical trial evaluating the safety and tolerability of human parthenogenetic stem cell derived neural stem cells ISC-hpNSC® for treating Parkinson’s disease (ClinicalTrials.gov Identifier NCT02452723).

The article and abstract can be found at:

http://www.nature.com/articles/srep34478



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