NCT06944522 · BlueRock Therapeutics
A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease
(exPDite-2)
What this study is about
Study BRT-DA01-301 is a Phase 3 conducted at multiple hospitals, randomly assigned, sham surgery-controlled, where neither patients nor doctors know which treatment is given study to assess effectiveness and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).
View original scientific 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).
Interventions
BIOLOGICAL
bemdaneprocel
Investigational cell therapy comprising midbrain dopaminergic neuron progenitors derived from human embryonic stem cells
PROCEDURE
Sham surgery
Sham surgery will be performed on Day 0
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Scottsdale, Arizona
- Sun City, Arizona
- Little Rock, Arkansas
- Los Angeles, California
- Orange, California
- Palo Alto, California
- Aurora, Colorado
- Washington D.C., District of Columbia
- Jacksonville, Florida
- Miami, Florida
- Tampa, Florida
- Chicago, Illinois
And 18 more locations — see the full list below.
Collaborators
Bayer
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 4, 2026 · Source of record for eligibility and locations