What this study is
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).
What's being tested
- bemdaneprocel
Intervention · BIOLOGICAL
Investigational cell therapy comprising midbrain dopaminergic neuron progenitors derived from human embryonic stem cells
- Sham surgery
Intervention · PROCEDURE
Sham surgery will be performed on Day 0
Study details
- 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
- Sponsor
- BlueRock Therapeutics
- Conditions
- Parkinsons Disease (PD)
- Enrolling
- 102 people
- Starts
- 2025-06-17
- Est. completion
- 2034-08
- Design
- Triple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 45 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (43)
43 openContact for every open site
- Patient Engagement · Contact1-877-380-3967clinicaltrials@bluerocktx.com
Mayo Clinic Scottsdale - Neurology
Scottsdale, Arizona, United States
RecruitingBanner Sun Health Research Institute
Sun City, Arizona, United States
RecruitingUniversity of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
RecruitingUCLA NeuroTranslational Research Center
Los Angeles, California, United States
RecruitingUCI Medical Center - Neurology
Orange, California, United States
RecruitingStanford Neuroscience Health Center
Palo Alto, California, United States
RecruitingUniversity of Colorado Hospital - Neurology Clinic
Aurora, Colorado, United States
RecruitingMedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
RecruitingMayo Clinic Jacksonville - Neurology
Jacksonville, Florida, United States
RecruitingUniversity of Miami Health System - Neurology
Miami, Florida, United States
RecruitingUSF Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States
RecruitingParkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital
Chicago, Illinois, United States
RecruitingRush University Medical Center - Neurology
Chicago, Illinois, United States
RecruitingUniversity of Kansas Medical Center
Kansas City, Kansas, United States
RecruitingUniversity of Louisville Hospital
Louisville, Kentucky, United States
RecruitingJohns Hopkins Hospital - Neurology
Baltimore, Maryland, United States
RecruitingTufts Medical Center - Neurology
Boston, Massachusetts, United States
RecruitingBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RecruitingMichigan Clinical Research Unit - Neurology
Ann Arbor, Michigan, United States
RecruitingUniversity of Michigan Clinical Research Unit - Neurology
Ann Arbor, Michigan, United States
RecruitingQuest Research Institute
Farmington Hills, Michigan, United States
RecruitingUBMD Neurology
Buffalo, New York, United States
RecruitingMount Sinai West - Neurology
New York, New York, United States
RecruitingNew York Presbyterian/Weill Cornell Medical Center
New York, New York, United States
RecruitingDuke Neurological Disorders Clinic
Durham, North Carolina, United States
RecruitingUniversity of Toledo Medical Center
Toledo, Ohio, United States
RecruitingOHSU Neurology Clinic, South Waterfront
Portland, Oregon, United States
RecruitingRhode Island Hospital - Neurology
Providence, Rhode Island, United States
RecruitingMedical University of South Carolina, Movement Disorders Dept.
Charleston, South Carolina, United States
RecruitingVanderbilt University Medical Center
Nashville, Tennessee, United States
RecruitingUTHealth Houston Neurosciences - Texas Medical Center
Houston, Texas, United States
RecruitingUniversity of Vermont Medical Center
Burlington, Vermont, United States
RecruitingVirginia Commonwealth University
Richmond, Virginia, United States
RecruitingEvergreenHealth - Research Department
Kirkland, Washington, United States
Recruiting
9 sites outside the US
NeuRA (Neuroscience Research Australia)
Randwick, New South Wales, Australia
RecruitingGold Coast Hospital & Health Service
Southport, Queensland, Australia
RecruitingPrincess Alexandra Hospital
Woolloongabba, Queensland, Australia
RecruitingMonash Medical Centre
Clayton, Victoria, Australia
RecruitingThe Alfred Hospital
Melbourne, Victoria, Australia
RecruitingThe Royal Melbourne Hospital
Parkville, Victoria, Australia
RecruitingThe University of British Columbia
Vancouver, British Columbia, Canada
RecruitingUniversity Health Network - Toronto Western Hospital
Toronto, Ontario, Canada
RecruitingCHUM - Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Recruiting
Study team
Sponsor
BlueRock Therapeutics
Study ID BRT-DA01-301
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.