Parkinsons Disease (PD)Phase 3exPDite-2NCT06944522
A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease
A Phase 3 study testing bemdaneprocel in people with Parkinsons Disease (PD), run by BlueRock Therapeutics at 43 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinsons Disease (PD)
- What is being tested?
- bemdaneprocel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 43 sitesin 3 countries
- Study dates
- 17 Jun 2025to Aug 2034
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
43 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
43 sites in 3 countries
United States34 sites, 34 recruiting
- Recruiting
Michigan Clinical Research Unit - Neurology
Ann Arbor, Michigan, 48109
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
University of Michigan Clinical Research Unit - Neurology
Ann Arbor, Michigan, 48109
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
University of Colorado Hospital - Neurology Clinic
Aurora, Colorado, 80045
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Johns Hopkins Hospital - Neurology
Baltimore, Maryland, 21287
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Tufts Medical Center - Neurology
Boston, Massachusetts, 02111
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
UBMD Neurology
Buffalo, New York, 14221
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Medical University of South Carolina, Movement Disorders Dept.
Charleston, South Carolina, 29425
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Parkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital
Chicago, Illinois, 60611
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Rush University Medical Center - Neurology
Chicago, Illinois, 60612
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Duke Neurological Disorders Clinic
Durham, North Carolina, 27710
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Quest Research Institute
Farmington Hills, Michigan, 48334
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
UTHealth Houston Neurosciences - Texas Medical Center
Houston, Texas, 77030
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Mayo Clinic Jacksonville - Neurology
Jacksonville, Florida, 32224
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160-8500
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
EvergreenHealth - Research Department
Kirkland, Washington, 98034
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
UCLA NeuroTranslational Research Center
Los Angeles, California, 90095
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
University of Louisville Hospital
Louisville, Kentucky, 40202
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
University of Miami Health System - Neurology
Miami, Florida, 33136
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Mount Sinai West - Neurology
New York, New York, 10019
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
New York Presbyterian/Weill Cornell Medical Center
New York, New York, 10065
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
UCI Medical Center - Neurology
Orange, California, 92868
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Stanford Neuroscience Health Center
Palo Alto, California, 94304
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
OHSU Neurology Clinic, South Waterfront
Portland, Oregon, 97239
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Rhode Island Hospital - Neurology
Providence, Rhode Island, 02903
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23284
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Mayo Clinic Scottsdale - Neurology
Scottsdale, Arizona, 85259
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Banner Sun Health Research Institute
Sun City, Arizona, 85351
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
USF Parkinson's Disease and Movement Disorders Center
Tampa, Florida, 33613
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
University of Toledo Medical Center
Toledo, Ohio, 43614
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
Australia6 sites, 6 recruiting
- Recruiting
Monash Medical Centre
Clayton, Victoria, 3168
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
NeuRA (Neuroscience Research Australia)
Randwick, New South Wales, 2031
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Gold Coast Hospital & Health Service
Southport, Queensland, 4215
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
Canada3 sites, 3 recruiting
- Recruiting
CHUM - Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
University Health Network - Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
- Recruiting
The University of British Columbia
Vancouver, British Columbia, V6T 1Z3
Patient Engagement, 1-877-380-3967, clinicaltrials@bluerocktx.com
About this study
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
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).
Read the detailed 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.
- Conditions
- Parkinsons Disease (PD)
- Being tested
- bemdaneprocel, Sham surgery
- Keywords
- exPDite-2, Cell Therapy, Cellular Therapy, Dopaminergic Neuronal Cell Therapy, Parkinsons Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bemdaneprocelBiological
Also called MSK-DA01, BRT-DA01
Investigational cell therapy comprising midbrain dopaminergic neuron progenitors derived from human embryonic stem cells
Sham surgeryProcedure or surgery
Sham surgery will be performed on Day 0
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Bemdaneprocel will be administered on Day 0 Receives: Biological: bemdaneprocel |
| Group B | Sham comparator | Sham surgery will be performed on Day 0 Receives: Procedure: Sham surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in PD diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day
Measured: From baseline to Week 78
Secondary outcomes (6)
Change from baseline in PD diary measure of OFF-time, adjusted for a 16-hour waking day
Measured: From baseline to Week 78
Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score in the off-medication state. Part III score can range from 0 to 132, with lower scores being better.
Measured: From baseline to Week 78
Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score. Part II score can range from 0 to 52, with lower scores being better.
Measured: From baseline to Week 78
Percentage change from baseline in 18F-DOPA uptake in the posterior putamen.
Measured: From baseline to Week 78
Change from baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index. Summary index score can range from 0 to 100, with lower scores being better.
Measured: From baseline to Week 78
Incidence and severity of treatment-emergent adverse events
Measured: From baseline to month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start17 Jun 2025
- Primary completionOct 2028 (estimated)
- Study completionAug 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsons Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the double-blind period, participants will be randomized at a 2:1 ratio to either receive bemdaneprocel or undergo sham surgery. Participants will receive immunosuppression or placebo equivalents for approximately 12 months. Approximately 18 months after the last participant is enrolled and based on the results of the primary analysis and review by the independent data monitoring committee (DMC), eligible participants who underwent sham surgery and remain actively enrolled in the study will have the opportunity to receive bemdaneprocel in the open-label period.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BlueRock Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944522
- Sponsor's protocol ID
- BRT-DA01-301
- Acronym
- exPDite-2
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06944522
- Acronym / sponsor ID
- exPDite-2 / BRT-DA01-301
- Conditions
- Parkinsons Disease (PD)
- Keywords
- exPDite-2, Cell Therapy, Cellular Therapy, Dopaminergic Neuronal Cell Therapy, Parkinsons Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- BlueRock TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Aug 2034 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- In the double-blind period, participants will be randomized at a 2:1 ratio to either receive bemdaneprocel or undergo sham surgery. Participants will receive immunosuppression or placebo equivalents for approximately 12 months. Approximately 18 months after the last participant is enrolled and based on the results of the primary analysis and review by the independent data monitoring committee (DMC), eligible participants who underwent sham surgery and remain actively enrolled in the study will have the opportunity to receive bemdaneprocel in the open-label period.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Biological: bemdaneprocelBemdaneprocel will be administered on Day 0 |
| Group B | Sham comparator | Procedure: Sham surgerySham surgery will be performed on Day 0 |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bemdaneprocelAlso: MSK-DA01, BRT-DA01Investigational cell therapy comprising midbrain dopaminergic neuron progenitors derived from human embryonic stem cells | Biological | Group A |
| Sham surgerySham surgery will be performed on Day 0 | Procedure or surgery | Group B |
Primary outcome
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
6 secondary outcomes
Change from baseline in PD diary measure of OFF-time, adjusted for a 16-hour waking day
Time frame: From baseline to Week 78
Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score in the off-medication state. Part III score can range from 0 to 132, with lower scores being better.
Time frame: From baseline to Week 78
Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score. Part II score can range from 0 to 52, with lower scores being better.
Time frame: From baseline to Week 78
Percentage change from baseline in 18F-DOPA uptake in the posterior putamen.
Time frame: From baseline to Week 78
Change from baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index. Summary index score can range from 0 to 100, with lower scores being better.
Time frame: From baseline to Week 78
Incidence and severity of treatment-emergent adverse events
Time frame: From baseline to month 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
43 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bemdaneprocel in people with Parkinsons Disease (PD), run by BlueRock Therapeutics at 43 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patient Engagement (1-877-380-3967, clinicaltrials@bluerocktx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.