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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06944522

Public ClinicalTrials.gov record NCT06944522. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 24, 2026, 9:47 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT06944522
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
BlueRock Therapeutics
Industry
Enrollment
102 participants

Conditions and interventions

Interventions

Biological · Procedure

Eligibility (public fields only)

Age range
45 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 16, 2025
Primary completion
Feb 28, 2027
Completion
Feb 29, 2032
Last update posted
Aug 3, 2026

2025 – 2032

United States locations

U.S. sites
34
U.S. states
23
U.S. cities
30
Facility City State ZIP Site status
Mayo Clinic Scottsdale - Neurology Scottsdale Arizona 85259 Recruiting
Banner Sun Health Research Institute Sun City Arizona 85351 Recruiting
University of Arkansas for Medical Sciences Little Rock Arkansas 72205 Recruiting
UCLA NeuroTranslational Research Center Los Angeles California 90095 Recruiting
UCI Medical Center - Neurology Orange California 92868 Recruiting
Stanford Neuroscience Health Center Palo Alto California 94304 Recruiting
University of Colorado Hospital - Neurology Clinic Aurora Colorado 80045 Recruiting
MedStar Georgetown University Hospital Washington D.C. District of Columbia 20007 Recruiting
Mayo Clinic Jacksonville - Neurology Jacksonville Florida 32224 Recruiting
University of Miami Health System - Neurology Miami Florida 33136 Recruiting
USF Parkinson's Disease and Movement Disorders Center Tampa Florida 33613 Recruiting
Parkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital Chicago Illinois 60611 Recruiting
Rush University Medical Center - Neurology Chicago Illinois 60612 Recruiting
University of Kansas Medical Center Kansas City Kansas 66160-8500 Recruiting
University of Louisville Hospital Louisville Kentucky 40202 Recruiting
Johns Hopkins Hospital - Neurology Baltimore Maryland 21287 Recruiting
Tufts Medical Center - Neurology Boston Massachusetts 02111 Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 Recruiting
Michigan Clinical Research Unit - Neurology Ann Arbor Michigan 48109 Recruiting
University of Michigan Clinical Research Unit - Neurology Ann Arbor Michigan 48109 Recruiting
Quest Research Institute Farmington Hills Michigan 48334 Recruiting
UBMD Neurology Buffalo New York 14221 Recruiting
Mount Sinai West - Neurology New York New York 10019 Recruiting
New York Presbyterian/Weill Cornell Medical Center New York New York 10065 Recruiting
Duke Neurological Disorders Clinic Durham North Carolina 27710 Recruiting
University of Toledo Medical Center Toledo Ohio 43614 Recruiting
OHSU Neurology Clinic, South Waterfront Portland Oregon 97239 Recruiting
Rhode Island Hospital - Neurology Providence Rhode Island 02903 Recruiting
Medical University of South Carolina, Movement Disorders Dept. Charleston South Carolina 29425 Recruiting
Vanderbilt University Medical Center Nashville Tennessee 37232 Recruiting
UTHealth Houston Neurosciences - Texas Medical Center Houston Texas 77030 Recruiting
University of Vermont Medical Center Burlington Vermont 05401 Recruiting
Virginia Commonwealth University Richmond Virginia 23284 Recruiting
EvergreenHealth - Research Department Kirkland Washington 98034 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06944522, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 3, 2026 · Synced Sep 24, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06944522 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →