International Stem Cell Corp., a California-based biotechnology company developing novel stem cell-based therapies, announced this morning that it has entered into a master clinical research agreement with Duke University to conduct clinical trials research in Parkinson’s disease using ISCO’s innovative neural stem cell product.
Mark Stacy, M.D., Vice Dean for Clinical Research, Neurology at Duke University School of Medicine and an internationally recognized leader in the field of Movement Disorders, including Parkinson’s disease, will be the study’s primary investigator. The research will be coordinated by the Duke Clinical Research Institute (DCRI), the world’s largest academic clinical research organization, which is internationally recognized for conducting groundbreaking clinical trials.
“We are pleased to have the opportunity to conduct the clinical trials related to ISCO’s investigational stem cell therapy in Parkinson’s disease patients,” stated Stacy. “Duke has an exceptional clinical trials team and we look forward to characterizing and understanding the safety and efficacy profile of this agent in the clinical trials setting.”
“We’re tremendously excited to be working with such a world-class clinical research organization as Duke University,” commented Dr. Ruslan Semechkin, Vice President of Research and Development at International Stem Cell Corporation. “Dr. Stacy and his team have made numerous significant contributions in the field of Parkinson’s disease research which together with Duke’s extensive clinical expertise in cell therapy clinical trials and the extensive patient population, gives us an outstanding opportunity to evaluate our revolutionary stem cell therapy.”
Stacy has extensive clinical trials experience, primarily involving neuro-protective and neuro-regenerative therapies and developing biomarkers for early diagnosis in Parkinson’s disease. He has published more than 100 peer-reviewed scientific papers in the field and has served as an advisor to a number of companies. He has participated in more than 100 clinical trials.
ISCO’s Parkinson’s disease program uses human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company’s proprietary histocompatible human pluripotent stem cells. The hPNSC are self-renewing mulitpotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to (1) differentiate into dopaminergic neurons and (2) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain-derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new and revolutionary opportunity for the treatment of Parkinson’s disease, especially in cases where current dopamine-replacement approaches fail to adequately control the symptoms.
For more information, visit www.internationalstemcell.com
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