RecruitingPhase 3NCT06944522

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

Sponsor

BlueRock Therapeutics

Enrollment

102 participants

Start Date

Jun 17, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinsons Disease (PD)

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).

Eligibility

Min Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cell transplant therapy called bemdaneprocel for people with Parkinson's disease. The treatment involves implanting specially grown dopamine-producing cells into the brain to replace those lost to the disease, with the hope of improving motor function long-term. **You may be eligible if...** - You are between 45 and 75 years old - You have an established Parkinson's disease diagnosis for at least 4 but fewer than 12 years - Your Parkinson's symptoms clearly improve with levodopa medication - You experience significant "off" time (periods when your medication isn't controlling symptoms) of at least 2.5 hours daily - You are currently on Parkinson's medications - You are vaccinated according to current guidelines for people with altered immune function **You may NOT be eligible if...** - You do not respond to levodopa treatment - You have had prior brain surgery for Parkinson's - You have certain other neurological or psychiatric conditions - You have a condition that would make brain surgery unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALbemdaneprocel

Investigational cell therapy comprising midbrain dopaminergic neuron progenitors derived from human embryonic stem cells

PROCEDURESham surgery

Sham surgery will be performed on Day 0

Locations(39)

Banner Sun Health Research Institute

Sun City, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

UCLA NeuroTranslational Research Center

Los Angeles, California, United States

UCI Medical Center - Neurology

Orange, California, United States

University of Colorado Hospital - Neurology Clinic

Aurora, Colorado, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

University of Miami Health System - Neurology

Miami, Florida, United States

USF Parkinson's Disease and Movement Disorders Center

Tampa, Florida, United States

Parkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Louisville Hospital

Louisville, Kentucky, United States

Johns Hopkins Hospital - Neurology

Baltimore, Maryland, United States

Tufts Medical Center - Neurology

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Michigan Clinical Research Unit - Neurology

Ann Arbor, Michigan, United States

University of Michigan Clinical Research Unit - Neurology

Ann Arbor, Michigan, United States

Quest Research Institute

Farmington Hills, Michigan, United States

UBMD Neurology

Buffalo, New York, United States

Mount Sinai West - Neurology

New York, New York, United States

New York Presbyterian/Weill Cornell Medical Center

New York, New York, United States

Duke Neurological Disorders Clinic

Durham, North Carolina, United States

University of Toledo Medical Center

Toledo, Ohio, United States

OHSU Neurology Clinic, South Waterfront

Portland, Oregon, United States

Rhode Island Hospital - Neurology

Providence, Rhode Island, United States

Medical University of South Carolina, Movement Disorders Dept.

Charleston, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UTHealth Houston Neurosciences - Texas Medical Center

Houston, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

Virginia Commonwealth University

Richmond, Virginia, United States

EvergreenHealth - Research Department

Kirkland, Washington, United States

NeuRA (Neuroscience Research Australia)

Randwick, New South Wales, Australia

Gold Coast Hospital & Health Service

Southport, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Monash Medical Centre

Clayton, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

The Royal Melbourne Hospital

Parkville, Victoria, Australia

The University of British Columbia

Vancouver, British Columbia, Canada

University Health Network - Toronto Western Hospital

Toronto, Ontario, Canada

CHUM - Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT06944522

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