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Recruiting Phase 3

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

NCT06944522 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2025-06-17
Last updated
2026-11-02

Condition(s) studied

Parkinsons Disease (PD)

Investigational drug(s) / intervention(s)

bemdaneprocelSham surgery

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

Sham surgery: Sham surgery will be performed on Day 0

Study 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

Sex
ALL
Min age
45 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of clinically established PD as defined by the International Parkinson and Movement Disorders Society * Individual of any sex ≥45 to ≤75 years of age at informed consent * Robust and clear response to DA therapy as defined by MDS-UPDRS Part III * ≥4 and \<12 years from time of PD diagnosis at informed consent * Must demonstrate responsiveness to levodopa therapy * Receiving medical therapy for the treatment of PD symptoms * ≥2.5 hours of daily OFF-time * Vaccinated per current national guidelines or local practice for patients with altered immunocompetence Exclusion Criteria: * PD presenting with recurrent falls * Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease other than PD, including multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, or Lewy body dementia * Any current or relevant previous history of serious, severe, or unstable physical, neurological, or psychiatric illness that may interfere with study participation, participant's safety, or assessment of endpoints per investigator's judgment * History of gene therapy or cell therapy for a neurological or intercerebral condition * Prior treatment with intrajejunal or subcutaneous infusion therapies for PD * Prior surgical or radiation therapy to the brain, including deep brain stimulation (DBS) and lesion therapy, or prior history of intradural spinal cord surgery * Contraindication to surgery, general anesthesia, cell therapy, immunosuppression, or other required drugs, or anything that prevents use of PET or MRI * Any history or evidence of infection with HBV or HIV; any active infection with HCV, CMV, syphilis, or latent tuberculosis; and any condition that, in the opinion of the investigator could put the participant at significant risk from immunosuppression or impact the participant's ability to perform study assessments. Exceptions: Treated and resolved TB, syphilis and/or HCV are not exclusionary * Current or previously active malignant disease within the past 5 years * Chronic immunosuppressive therapy * Receipt of another investigational therapy within 5 half-lives of the active treatment * Pregnancy or breastfeeding * Unable to comply with study requirements for any reason

Primary outcome measure(s)

  • Change from baseline in PD diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day — From baseline to Week 78

Trial sites (43)

FacilityCityRegionStatus
Mayo Clinic Scottsdale - Neurology Scottsdale Arizona Recruiting
Banner Sun Health Research Institute Sun City Arizona Recruiting
University of Arkansas for Medical Sciences Little Rock Arkansas Recruiting
UCLA NeuroTranslational Research Center Los Angeles California Recruiting
UCI Medical Center - Neurology Orange California Recruiting
Stanford Neuroscience Health Center Palo Alto California Recruiting
University of Colorado Hospital - Neurology Clinic Aurora Colorado Recruiting
MedStar Georgetown University Hospital Washington D.C. District of Columbia Recruiting
Mayo Clinic Jacksonville - Neurology Jacksonville Florida Recruiting
University of Miami Health System - Neurology Miami Florida Recruiting
USF Parkinson's Disease and Movement Disorders Center Tampa Florida Recruiting
Parkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital Chicago Illinois Recruiting
Rush University Medical Center - Neurology Chicago Illinois Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
University of Louisville Hospital Louisville Kentucky Recruiting
Johns Hopkins Hospital - Neurology Baltimore Maryland Recruiting
Tufts Medical Center - Neurology Boston Massachusetts Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Michigan Clinical Research Unit - Neurology Ann Arbor Michigan Recruiting
University of Michigan Clinical Research Unit - Neurology Ann Arbor Michigan Recruiting
Quest Research Institute Farmington Hills Michigan Recruiting
UBMD Neurology Buffalo New York Recruiting
Mount Sinai West - Neurology New York New York Recruiting
New York Presbyterian/Weill Cornell Medical Center New York New York Recruiting
Duke Neurological Disorders Clinic Durham North Carolina Recruiting
University of Toledo Medical Center Toledo Ohio Recruiting
OHSU Neurology Clinic, South Waterfront Portland Oregon Recruiting
Rhode Island Hospital - Neurology Providence Rhode Island Recruiting
Medical University of South Carolina, Movement Disorders Dept. Charleston South Carolina Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
UTHealth Houston Neurosciences - Texas Medical Center Houston Texas Recruiting
University of Vermont Medical Center Burlington Vermont Recruiting
Virginia Commonwealth University Richmond Virginia Recruiting
EvergreenHealth - Research Department Kirkland Washington Recruiting
NeuRA (Neuroscience Research Australia) Randwick New South Wales Recruiting
Gold Coast Hospital & Health Service Southport Queensland Recruiting
Princess Alexandra Hospital Woolloongabba Queensland Recruiting
Monash Medical Centre Clayton Victoria Recruiting
The Alfred Hospital Melbourne Victoria Recruiting
The Royal Melbourne Hospital Parkville Victoria Recruiting

+ 3 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06944522 on ClinicalTrials.gov ↗ ← All trials in Australia