Recruiting

Phase 3

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

Sponsor:

BlueRock Therapeutics

Code:

NCT06944522

Conditions

Parkinsons Disease (PD)

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

bemdaneprocel

Sham surgery

Study Details

Brief 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).

Conditions

Parkinsons Disease (PD)

Study ID

NCT06944522

Start date

Jun 17, 2025

Status verified date

Jul, 2026

Completion date

Mar, 2032

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

102 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group A

Bemdaneprocel will be administered on Day 0

sham comparator: Group B

Sham surgery will be performed on Day 0

Interventions

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

Primary outcome measure

Change from baseline in PD diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day [ Time Frame: From baseline to Week 78 ]

Central Contacts and Locations

Central contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Locations

Mayo Clinic Scottsdale - Neurology

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Banner Sun Health Research Institute

Recruiting

Sun City, Arizona, United States, 85351

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

UCLA NeuroTranslational Research Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

UCI Medical Center - Neurology

Recruiting

Orange, California, United States, 92868

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Stanford Neuroscience Health Center

Recruiting

Palo Alto, California, United States, 94304

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

University of Colorado Hospital - Neurology Clinic

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

MedStar Georgetown University Hospital

Recruiting

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

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Mayo Clinic Jacksonville - Neurology

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

University of Miami Health System - Neurology

Recruiting

Miami, Florida, United States, 33136

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

USF Parkinson's Disease and Movement Disorders Center

Recruiting

Tampa, Florida, United States, 33613

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

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

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Rush University Medical Center - Neurology

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160-8500

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

University of Louisville Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Johns Hopkins Hospital - Neurology

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Tufts Medical Center - Neurology

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Michigan Clinical Research Unit - Neurology

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

University of Michigan Clinical Research Unit - Neurology

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Quest Research Institute

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

UBMD Neurology

Recruiting

Buffalo, New York, United States, 14221

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Mount Sinai West - Neurology

Recruiting

New York, New York, United States, 10019

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

New York Presbyterian/Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Duke Neurological Disorders Clinic

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

University of Toledo Medical Center

Recruiting

Toledo, Ohio, United States, 43614

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

OHSU Neurology Clinic, South Waterfront

Recruiting

Portland, Oregon, United States, 97239

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Rhode Island Hospital - Neurology

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Medical University of South Carolina, Movement Disorders Dept.

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

UTHealth Houston Neurosciences - Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23284

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

EvergreenHealth - Research Department

Recruiting

Kirkland, Washington, United States, 98034

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

The University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6T 1Z3

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

University Health Network - Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

CHUM - Centre hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Contacts

Patient Engagement

1-877-380-3967 clinicaltrials@bluerocktx.com

More Information

Sponsor

BlueRock Therapeutics

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Keywords

exPDite-2
Cell Therapy
Cellular Therapy
Dopaminergic Neuronal Cell Therapy
Parkinsons Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BlueRock Therapeutics on 2026-08-04.