Full Title
exPDite-2: A Phase 3 Study to Assess the Efficacy and Safety of Midbrain Dopaminergic Neuronal Cell Therapy (Bemdaneprocel) for Participants With Parkinson’s Disease (Advarra IRB)Purpose
Researchers want to see if bemdaneprocel improves symptoms in people with Parkinson’s disease (PD). PD symptoms are due to a loss of cells that make a chemical in your brain called dopamine.
Bemdaneprocel is a cell therapy composed of live brain cells that make dopamine. It is made in a laboratory from stem cells which are transformed into brain cells that can make dopamine. Bemdaneprocel is meant to replace the cells that have been lost from your brain.
If you take part in this study, you will be randomly assigned to one of two groups:
- If you are in Group A, you will have surgery to inject bemdaneprocel into each side of your brain.
- If you are in Group B, you will have sham surgery. The surgeon will make partial cuts and you will not receive bemdaneprocel injections.
Contact
For more information about this study or to see if you can join, please call Dr. Cameron Brennan’s office at 212-639-8268.
Protocol
25-320
Phase
Phase III (phase 3)
Investigator
Co-Investigators
Diseases
Locations
ClinicalTrials.gov ID
NCT06944522
ClinicalTrials.gov