NCT06944522

A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: BlueRock Therapeutics · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled, double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).

Detailed description

The BRT-DA01-301 study is a Phase 3, multicenter, randomized, sham surgery-controlled, double-blind study involving approximately 102 participants with Parkinson's Disease (PD). Participants will be randomized in a 2:1 ratio to either receive bemdaneprocel or undergo sham surgery. The study includes an immunosuppression regimen and placebo equivalents to maintain blinding. The primary objective is to evaluate the efficacy of bemdaneprocel on motor symptoms in participants with PD. The secondary objective is to evaluate the effects of bemdaneprocel on Motor function, Quality of life, Non-motor symptoms of PD, Disease severity, and Use of PD medications or therapies compared with participants who undergo sham surgery. Participants will be followed for at least 18 months in the double-blind period and up to five years if they receive bemdaneprocel.

Conditions

• Parkinsons Disease (PD)

Interventions

Type	Name	Description
BIOLOGICAL	bemdaneprocel	Investigational cell therapy comprising midbrain dopaminergic neuron progenitors derived from human embryonic stem cells
PROCEDURE	Sham surgery	Sham surgery will be performed on Day 0

Timeline

• Start date: 2025-06-17
• Primary completion: 2027-03-01
• Completion: 2032-03-01
• First posted: 2025-04-25
• Last updated: 2026-04-01

Locations

37 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study