Clinical Trials Network

The exPDite-2 study is a Phase 3 clinical trial investigating a new cell therapy called bemdaneprocel for people living with Parkinson's disease. The goal of the study is to determine whether this treatment can safely improve Parkinson's symptoms and quality of life.

Parkinson's disease occurs when dopamine-producing nerve cells in the brain gradually die. Bemdaneprocel is a laboratory-grown cell therapy designed to replace some of these lost dopamine-producing cells. Researchers hope that these new cells will survive in the brain and help restore dopamine production, which may improve movement and other symptoms of Parkinson's disease.

Approximately 102 participants will take part in this international study. Participants will be randomly assigned to either receive bemdaneprocel through brain surgery or undergo a sham (placebo) surgical procedure. Neither participants nor most study staff will know which treatment was received during the main study period.

Researchers will assess whether bemdaneprocel improves motor symptoms, daily functioning, quality of life, non-motor symptoms, and the need for Parkinson's medications. Participants will be followed closely for safety and effectiveness for at least 18 months, with longer-term follow-up available for those who receive the cell therapy.

This study represents one of the most advanced investigations of stem cell-derived therapies for Parkinson's disease and aims to determine whether replacing lost dopamine-producing cells can provide meaningful benefits for people living with the condition.

This Phase 1 clinical trial is investigating SER-252, an experimental treatment for people with Parkinson's disease who experience motor fluctuations, including periods when their medication wears off and symptoms return ("OFF" time). The primary goal of the study is to evaluate the safety and tolerability of SER-252 and understand how the treatment is processed by the body.

SER-252 is a new long-acting form of apomorphine, a medication that mimics the effects of dopamine in the brain. It has been designed to provide a sustained release of medication over time, with the aim of helping people manage OFF periods more effectively than currently available treatments. Researchers hope this approach may provide longer-lasting symptom control for people living with Parkinson's disease.

Approximately 40 participants will take part in the study. Participants will be randomly assigned to receive either a single dose of SER-252 or a placebo. The treatment is administered through a small device that delivers the medication under the skin. Different groups of participants will receive increasing dose levels of SER-252 so that researchers can carefully evaluate safety at each stage of the study. Neither participants nor most study staff will know which treatment has been administered.

Researchers will closely monitor participants for side effects, measure how long the medication remains in the body, and assess how the body responds to treatment. The study will also explore whether SER-252 shows early signs of improving Parkinson's symptoms and reducing OFF periods.

This study represents an important step in the development of a potential new long-acting treatment option for Parkinson's disease. The results will help determine whether SER-252 should progress to larger studies designed to evaluate its effectiveness in reducing motor fluctuations and improving quality of life.