Duke to Act as CRO for ISCO's Stem Cell Parkinson's Disease Trial

Related tags Clinical trials Stem cell Dopamine

Duke to Act as CRO for ISCO
Duke to Act as CRO for ISCO
Duke University will play contract research organisation (CRO) for clinical trials of a Parkinson’s disease treatment being developed by International Stem Cell Corp (ISCO).

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.

Related news

Show more

Related products

show more

Automated metadata management in clinical trials

Automated metadata management in clinical trials

Content provided by Formedix | 01-Aug-2023 | White Paper

When it comes to efficient clinical study build, content is king. Most importantly: metadata content. In this blog, we explore the role of metadata in...

Small Molecule development – getting it right

Small Molecule development – getting it right

Content provided by Lonza Small Molecules | 20-Jun-2023 | Insight Guide

Small Molecule drug development is something more and more ambitious emerging pharmaceutical companies are taking on from end to end. But this path can...

Validate clinical study data with Formedix CORE

Validate clinical study data with Formedix CORE

Content provided by Formedix | 19-Jun-2023 | White Paper

In April 2023 at the CDISC Europe Interchange, we launched Formedix CORE, the first free-to-use, downloadable application encompassing the CDISC Open Rules...

Related suppliers

Follow us


View more