A Phase 3 Study of Bemdaneprocel for People With Parkinson's Disease

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.

Who Can Join

To join this study, there are a few conditions. You must:

• Have Parkinson’s disease that was diagnosed within the last 4-12 years.
• Have not had prior gene therapy, cell therapy, brain surgery, or radiation therapy to the brain.
• Be able to undergo brain surgery.
• Be age 45-75.

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.