Duke to Act as CRO for ISCO's Stem Cell Parkinson's Disease Trial
The master clinical research agreement – financial terms of which were not disclosed – will see Mark Stacy, Vice Dean for Clinical Research, Neurology at Duke University School of Medicine, lead the project as principal investigator.
He said that: “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.
"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."
Ruslan Semechkin, R&D VP at ISCO, said: "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."
New therapy?
ISCO’s approach is to transform pathenogenetic neural stem cells (hPNSC) into dopaminergic neurons that express neurotrophic factors like glial derived neurotrophic factor (GDNF) and brain-derived neurotrophic factor (BDNF).
These compounds can protect the nigrostriatal system - one of the four main dopaminergic pathway involved in controlling movement – against damage resulting from the development on Parkinson’s disease.
The idea is that these cells or at least the chemicals they produce could be used to develop treatments that replace current therapies that rely on dopamine replacement, which can only be used for a limited period.
According to data presented at the American Academy of Neurology (AAN) 65th Annual Meeting earlier this year primates implanted with the hPNSC cells had higher levels of dopamine than those in a comparator group that did not receive the grafts.
