International Stem Cell Corp., a biotechnology company focused on the therapeutic applications of human parthenogenetic stem cells (hpSC), this morning announced the safety and encouraging efficacy of its stem cell therapy in rodent and non-human primate models of Parkinson’s disease.
“This pilot study represents a first essential step in bringing cell-based therapies for Parkinson’s disease to clinical trials,” stated co-author of the study Evan Y. Snyder, MD, PhD, Director of Stem Cells and Regenerative Biology Program at Sanford Burnham Medical Research Institute.
Designed to demonstrate the viability, fate, and functional efficacy of the stem cell derived neural cells after implantation to the brain, these placebo-controlled studies involved highly pure populations of neuronal cells that were differentiated from hpSCs according to the protocol developed by ISCO and recently published in the Nature Publishing Group’s Scientific Reports.
The studies employ MPTP-lesioned African Green monkeys and 6-OHDA-lesioned rats, the principle models used to study Parkinson’s disease. The duration of the primate study was four months and the rodent study six months. In the non-human primate model, behavioral endpoints were assessed with parkinsonian scores. These scores, based on a standardized rating scale, were recorded by observers blinded to whether the primates were in the treatment or control group. Observations were done twice per day, five days per week. In the rodent model, behavioral improvement was assessed using the cylinder test, amphetamine, and apomorphine induced rotation tests. Cell engraftment, viability, and phenotype of the implanted cells were determined histologically at the end of the studies. Tumorigenicity and safety of the therapy was assessed at the end of both the rodent and primate studies by gross necropsy and brain histology.
Following the implantation of the neuronal cells, all monkeys in the treatment group had higher levels of dopamine in the brain compared with the control group. Additionally, the rats in the treatment group showed gradual improvements in motor symptoms consistent with cells survival, engraftment, and dopamine release. No adverse events, including dyskinesia, deformations, tumors, or overgrowth, were observed in the rat or monkey treatment groups. These exciting results provide solid evidence that hpSC-derived neuronal cells can be safe and have a disease modifying effect. Although preliminary, these results further support the belief that ISCO’s approach to Parkinson’s disease treatment is highly promising.
“These results are pivotal for our pre-clinical Parkinson’s program showing, as they do, that the hpSC-derived neuronal cells can potentially ameliorate the behavioral symptoms without triggering dyskinesias. This data forms the foundation of our discussions with the FDA as we move towards our IND in 2013,” said Dr. Ruslan Semechkin, Principal Investigator of this study, head of R&D for International Stem Cell Corporation and Member of the American Academy of Neurology.
According to today’s press release, these results will be presented and discussed at the 65th American Academy of Neurology Annual Meeting, one of the world’s most important annual events for neurologists and neuroscience professionals and the largest such international meeting of its kind with more than 12,000 attendees at last year’s meeting.
Location: San Diego Convention Center, 111 W Harbor Dr., San Diego, CA 92101
Session: Movement Disorders; Parkinson’s Disease Therapeutics
Date and time: March 20th, 2012 at 3:30 PM PDT
For more information on ISCO’s hpSC technology and the Parkinson’s disease study, visit www.internationalstemcell.com
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