Testing bemdaneprocel against a placebo for parkinsons disease (PD)
Official title: A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease
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
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
Canadian Sites (3)
The University of British Columbia
Vancouver, British Columbia, Canada
University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada
CHUM - Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for20 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +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
- −Any active infection (including but not limited to HIV, HCV, HBV, CMV, syphilis, or tuberculosis) or condition that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → could put the participant at significant risk from immunosuppression or impact the participant's ability to perform study assessments
- −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 endpointsEndpointThe specific thing a study measures to answer its question.Read more → per investigator's judgment
- −History of gene therapy or cell therapy
- −Prior treatment with intrajejunal or subcutaneous infusion therapies for PD
- −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
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: bemdaneprocel, ShamSham procedureA procedure made to feel like the real one, without the active step.Read more → surgery.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a sham procedureSham procedureA procedure made to feel like the real one, without the active step.Read more → — one made to feel like the real thing but without the active step.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 45 years to 75 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 102 people.
The study is currently expected to finish around March 2032.
The main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 78.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → in PD diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day — measured over From baseline to Week 78.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06944522 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About bemdaneprocelBiological
Investigational cell therapy comprising midbrain dopaminergic neuron progenitors derived from human embryonic stem cells
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About Sham surgeryProcedure
Sham surgery will be performed on Day 0
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 45 years to 75 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study includes a shamSham procedureA procedure made to feel like the real one, without the active step.Read more → comparison — a procedure made to feel like the real one, without the active step.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 45 years to 75 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 78.
The study as a whole is currently expected to finish around 2032-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 102 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 8 locations, including: Vancouver, British Columbia, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Ann Arbor, Michigan, United States; Farmington Hills, Michigan, United States; Buffalo, New York, United States, and 2 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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).
Other Sites (7)
Michigan Clinical Research Unit - Neurology
Ann Arbor, Michigan, United States
University of Michigan Clinical Research Unit - Neurology
Ann Arbor, Michigan, United States
Quest Research Institute
Farmington Hills, Michigan, United States
UBMD Neurology
Buffalo, New York, United States
Mount Sinai West - Neurology
New York, New York, United States
New York Presbyterian/Weill Cornell Medical Center
New York, New York, United States
EvergreenHealth - Research Department
Kirkland, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.