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Testing bemdaneprocel for Parkinson’s

Researchers compare the study treatment bemdaneprocel with a comparison surgery designed for the trial, checking both its effects and safety.

Testing a treatment or activity · Study reference: NCT06944522

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

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Looking for volunteers

Start (reported actual date)
2025-06-17
Main measurements finished (planned)
2027-03
Study finished (planned)
2032-03

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 45 years to 75 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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 * 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 active infection (including but not limited to HIV, HCV, HBV, CMV, syphilis, or tuberculosis) or 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 * 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
Full study name & original research details

Official study 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

Short title used by the registry

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

Original description

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).

Further description from the registry

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 reported: Parkinsons Disease (PD)

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
bemdaneprocel; Sham surgery
Phases
PHASE3
Sponsor
BlueRock Therapeutics
Start date reported by registry
2025-06-17 (actual)

Registry updated: 2026-08-04 · Status last verified by the registry submitter: 2026-07

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Mayo Clinic Scottsdale - Neurology

Scottsdale, Arizona, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Banner Sun Health Research Institute

Sun City, Arizona, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

UCLA NeuroTranslational Research Center

Los Angeles, California, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

UCI Medical Center - Neurology

Orange, California, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Stanford Neuroscience Health Center

Palo Alto, California, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

University of Colorado Hospital - Neurology Clinic

Aurora, Colorado, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

MedStar Georgetown University Hospital

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

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Mayo Clinic Jacksonville - Neurology

Jacksonville, Florida, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

University of Miami Health System - Neurology

Miami, Florida, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

USF Parkinson's Disease and Movement Disorders Center

Tampa, Florida, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

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

Chicago, Illinois, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Rush University Medical Center - Neurology

Chicago, Illinois, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

University of Kansas Medical Center

Kansas City, Kansas, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

University of Louisville Hospital

Louisville, Kentucky, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Johns Hopkins Hospital - Neurology

Baltimore, Maryland, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Tufts Medical Center - Neurology

Boston, Massachusetts, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Michigan Clinical Research Unit - Neurology

Ann Arbor, Michigan, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

University of Michigan Clinical Research Unit - Neurology

Ann Arbor, Michigan, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Quest Research Institute

Farmington Hills, Michigan, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

UBMD Neurology

Buffalo, New York, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Mount Sinai West - Neurology

New York, New York, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

New York Presbyterian/Weill Cornell Medical Center

New York, New York, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Duke Neurological Disorders Clinic

Durham, North Carolina, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

University of Toledo Medical Center

Toledo, Ohio, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

OHSU Neurology Clinic, South Waterfront

Portland, Oregon, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Rhode Island Hospital - Neurology

Providence, Rhode Island, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Medical University of South Carolina, Movement Disorders Dept.

Charleston, South Carolina, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

UTHealth Houston Neurosciences - Texas Medical Center

Houston, Texas, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

University of Vermont Medical Center

Burlington, Vermont, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Virginia Commonwealth University

Richmond, Virginia, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

EvergreenHealth - Research Department

Kirkland, Washington, United States

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

NeuRA (Neuroscience Research Australia)

Randwick, New South Wales, Australia

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Gold Coast Hospital & Health Service

Southport, Queensland, Australia

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Monash Medical Centre

Clayton, Victoria, Australia

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

The Alfred Hospital

Melbourne, Victoria, Australia

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

The University of British Columbia

Vancouver, British Columbia, Canada

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

University Health Network - Toronto Western Hospital

Toronto, Ontario, Canada

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

CHUM - Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Recruiting

Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.