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-   -   International Stem Cell Presents Preclinical Parkinson's Disease Data (https://www.neurotalk.org/parkinson-s-disease/212362-international-stem-cell-preclinical-parkinsons-disease-data.html)

Tupelo3 11-18-2014 01:20 PM

International Stem Cell Presents Preclinical Parkinson's Disease Data
 
The preclinical data will form the basis for the Company's regulatory submission for its Phase 1 study in Parkinson's disease. The Company plans to submit materials before the end of 2014 for regulatory approval to begin its first stem cell clinical trial in Parkinson's disease and anticipates the study to begin in the first quarter of 2015.

"We are very pleased with the long-term safety and efficacy data of human parthenogenetic neural stem cells, having seen no adverse reactions, no evidence of teratoma formation and no ectopic tissue in our GLP and non-GLP animal studies," said Ruslan Semechkin, Ph.D. "There is a large unmet medical need for new treatments that may halt or reverse the progression of Parkinson's disease and we believe our human neural stem cells may fill this need for the millions of people with this disease."

The data presented are from both safety studies, where human parthenogenetic neural stem cells (hpNSC) were transplanted into the brains of healthy animals, and proof-of-principle studies where the cells were transplanted into animals with induced Parkinson's disease symptoms. The studies show that hpNSC migrated to the injured brain area, increased dopamine levels, protected and recovered neurons and improved the motor function. Additionally, at the conclusion of the twelve months non-human primate safety study, no evidence of teratoma formation or ectopic tissue was found in any animals that received the human cell transplants.

http://www.internationalstemcell.com...zID=1468&G=583

badboy99 11-19-2014 10:17 AM

http://www.internationalstemcell.com/

Where is the trial info?


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