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

Last updated: March 31, 2026
Sponsor: BlueRock Therapeutics
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Sham surgery

bemdaneprocel

Clinical Study ID

NCT06944522
BRT-DA01-301
  • Ages 45-75
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of clinically established PD as defined by the International Parkinson andMovement 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 withaltered immunocompetence

Exclusion

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, corticobasaldegeneration, 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, orother required drugs, or anything that prevents use of PET or MRI

  • Any active infection (including but not limited to HIV, HCV, HBV, CMV, syphilis, ortuberculosis) or condition that, in the opinion of the investigator could put theparticipant at significant risk from immunosuppression or impact the participant'sability 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 activetreatment

  • Pregnancy or breastfeeding

Study Design

Total Participants: 102
Treatment Group(s): 2
Primary Treatment: Sham surgery
Phase: 3
Study Start date:
June 17, 2025
Estimated Completion Date:
March 31, 2032

Study 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.

Connect with a study center

  • NeuRA (Neuroscience Research Australia)

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • NeuRA (Neuroscience Research Australia)

    Randwick 2208285, New South Wales 2155400 2031
    Australia

    Site Not Available

  • Gold Coast Hospital & Health Service

    Southport, Queensland 4215
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Gold Coast Hospital & Health Service

    Southport 2148928, Queensland 2152274 4215
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba 6943568, Queensland 2152274 4102
    Australia

    Site Not Available

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • The Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • Monash Medical Centre

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne 2158177, Victoria 2145234 3004
    Australia

    Site Not Available

  • The Royal Melbourne Hospital

    Parkville 2153770, Victoria 2145234 3050
    Australia

    Site Not Available

  • The University of British Columbia

    Vancouver, British Columbia V6T 1Z3
    Canada

    Active - Recruiting

  • University Health Network - Toronto Western Hospital

    Toronto, Ontario M5T 2S8
    Canada

    Active - Recruiting

  • University Health Network - Toronto Western Hospital

    Toronto 6167865, Ontario 6093943 M5T 2S8
    Canada

    Site Not Available

  • CHUM - Centre hospitalier de l'Université de Montréal

    Montreal, Quebec H2X 0C1
    Canada

    Active - Recruiting

  • CHUM - Centre hospitalier de l'Université de Montréal

    Montreal 6077243, Quebec 6115047 H2X 0C1
    Canada

    Site Not Available

  • Banner Sun Health Research Institute

    Sun City, Arizona 85351
    United States

    Active - Recruiting

  • Banner Sun Health Research Institute

    Sun City 5316201, Arizona 5551752 85351
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Site Not Available

  • UCLA NeuroTranslational Research Center

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • UCLA NeuroTranslational Research Center

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • University of Colorado Hospital - Neurology Clinic

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Colorado Hospital - Neurology Clinic

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia 20007
    United States

    Active - Recruiting

  • MedStar Georgetown University Hospital

    Washington D.C. 4140963, District of Columbia 4138106 20007
    United States

    Site Not Available

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • University of Miami Health System - Neurology

    Miami, Florida 33136
    United States

    Active - Recruiting

  • USF Parkinson's Disease and Movement Disorders Center

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton 4148411, Florida 4155751 33486
    United States

    Site Not Available

  • University of Miami Health System - Neurology

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • USF Parkinson's Disease and Movement Disorders Center

    Tampa 4174757, Florida 4155751 33613
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

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

    Chicago, Illinois 60611
    United States

    Active - Recruiting

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

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160-8500
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City 4273837, Kansas 4273857 66160-8500
    United States

    Site Not Available

  • University of Louisville Hospital

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • University of Louisville Hospital

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Site Not Available

  • Johns Hopkins Hospital - Neurology

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114-2696
    United States

    Site Not Available

  • Tufts Medical Center - Neurology

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Tufts Medical Center - Neurology

    Boston 4930956, Massachusetts 6254926 02111
    United States

    Active - Recruiting

  • Michigan Clinical Research Unit - Neurology

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of Michigan Clinical Research Unit - Neurology

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Michigan Clinical Research Unit - Neurology

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • University of Michigan Clinical Research Unit - Neurology

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • Quest Research Institute

    Farmington Hills 4992523, Michigan 5001836 48334
    United States

    Site Not Available

  • UBMD Neurology

    Buffalo, New York 14221
    United States

    Active - Recruiting

  • Mount Sinai West - Neurology

    New York, New York 10019
    United States

    Active - Recruiting

  • New York Presbyterian/Weill Cornell Medical Center

    New York, New York 10065
    United States

    Active - Recruiting

  • UBMD Neurology

    Buffalo 5110629, New York 5128638 14221
    United States

    Site Not Available

  • Mount Sinai West - Neurology

    New York 5128581, New York 5128638 10019
    United States

    Site Not Available

  • New York Presbyterian/Weill Cornell Medical Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • University of Toledo Medical Center

    Toledo, Ohio 43614
    United States

    Active - Recruiting

  • University of Toledo Medical Center

    Toledo 5174035, Ohio 5165418 43614
    United States

    Site Not Available

  • OHSU Neurology Clinic, South Waterfront

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Rhode Island Hospital - Neurology

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Rhode Island Hospital - Neurology

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Site Not Available

  • Medical University of South Carolina, Movement Disorders Dept.

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • UTHealth Houston Neurosciences - Texas Medical Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • UTHealth Houston Neurosciences - Texas Medical Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Active - Recruiting

  • University of Vermont Medical Center

    Burlington 5234372, Vermont 5242283 05401
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23284
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond 4781708, Virginia 6254928 23284
    United States

    Site Not Available

  • EvergreenHealth - Research Department

    Kirkland, Washington 98034
    United States

    Active - Recruiting

  • EvergreenHealth - Research Department

    Kirkland 5799841, Washington 5815135 98034
    United States

    Site Not Available

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