Actively Recruiting
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
Led by BlueRock Therapeutics · Updated on 2026-06-05
102
Participants Needed
40
Research Sites
261 weeks
Total Duration
On this page
Sponsors
B
BlueRock Therapeutics
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of bemdaneprocel, an investigational cell therapy made of midbrain dopaminergic neuron progenitors from human embryonic stem cells, in adults with Parkinson's Disease (PD). This Phase 3, multicenter, randomized, sham surgery-controlled, double-blind study involves about 102 participants to assess how bemdaneprocel affects motor symptoms and other aspects of PD compared to a sham surgery procedure. Participants will be randomly assigned in a 2:1 ratio to receive either a single administration of bemdaneprocel or undergo sham surgery, both performed on Day 0. An immunosuppression regimen and placebo treatments are used to maintain blinding. The study includes an 18-month double-blind follow-up period, with those receiving bemdaneprocel monitored for up to five years. Throughout the study, participants will undergo assessments including PD diary measures of ON-time without troublesome dyskinesia, OFF-time, and rating scales for motor function and quality of life. Safety will be monitored through reports of adverse events over up to 60 months. Participants will receive regular evaluations to track disease severity, symptom changes, medication use, and overall health during the study.
CONDITIONS
Brief Title
A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of clinically established Parkinson's Disease as defined by the International Parkinson and Movement Disorders Society
- Any sex aged 45 to 75 years at informed consent
- Clear and strong response to dopamine therapy as defined by MDS-UPDRS Part III
- Between 4 and less than 12 years since Parkinson's Disease diagnosis at informed consent
- Must respond to levodopa therapy
- Currently receiving medical therapy for Parkinson's Disease symptoms
- At least 2.5 hours of daily OFF-time
- Vaccinated according to current national or local guidelines for patients with altered immune function
You will not qualify if you...
- Parkinson's Disease with recurrent falls
- Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or other neurodegenerative diseases such as multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, or Lewy body dementia
- Serious, severe, or unstable physical, neurological, or psychiatric illness that may affect safety or study participation
- History of gene therapy or cell therapy
- Prior intrajejunal or subcutaneous infusion therapies for Parkinson's Disease
- Previous brain surgery or radiation therapy including deep brain stimulation or lesion therapy, or spinal cord surgery
- Contraindications to surgery, anesthesia, cell therapy, immunosuppression, or inability to undergo PET or MRI
- Active infections like HIV, HCV, HBV, CMV, syphilis, or tuberculosis or conditions increasing risk from immunosuppression
- Current or recent malignant disease within 5 years
- Chronic immunosuppressive therapy
- Use of another investigational therapy within 5 half-lives of active treatment
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants undergo either bemdaneprocel administration or sham surgery on Day 0 along with an immunosuppression regimen to maintain blinding.
1 surgery day visit
Duration - At least 18 months up to 5 years depending on treatment group
Participants receive active cell therapy or sham surgery and are monitored for efficacy and safety of the intervention.
Regular visits during the double-blind period up to 18 months, and extended follow-up visits for up to 5 years for those receiving bemdaneprocel
Trial Site Locations
Total: 40 locations
1
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
Actively Recruiting
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
UCLA NeuroTranslational Research Center
Los Angeles, California, United States, 90095
Actively Recruiting
4
UCI Medical Center - Neurology
Orange, California, United States, 92868
Actively Recruiting
5
University of Colorado Hospital - Neurology Clinic
Aurora, Colorado, United States, 80045
Actively Recruiting
6
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
7
University of Miami Health System - Neurology
Miami, Florida, United States, 33136
Actively Recruiting
8
USF Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States, 33613
Actively Recruiting
9
Parkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
10
Rush University Medical Center - Neurology
Chicago, Illinois, United States, 60612
Actively Recruiting
11
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-8500
Actively Recruiting
12
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
13
Johns Hopkins Hospital - Neurology
Baltimore, Maryland, United States, 21287
Actively Recruiting
14
Tufts Medical Center - Neurology
Boston, Massachusetts, United States, 02111
Actively Recruiting
15
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
16
Michigan Clinical Research Unit - Neurology
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
17
University of Michigan Clinical Research Unit - Neurology
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
18
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
19
UBMD Neurology
Buffalo, New York, United States, 14221
Actively Recruiting
20
Mount Sinai West - Neurology
New York, New York, United States, 10019
Actively Recruiting
21
New York Presbyterian/Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
22
Duke Neurological Disorders Clinic
Durham, North Carolina, United States, 27710
Actively Recruiting
23
University of Toledo Medical Center
Toledo, Ohio, United States, 43614
Actively Recruiting
24
OHSU Neurology Clinic, South Waterfront
Portland, Oregon, United States, 97239
Actively Recruiting
25
Rhode Island Hospital - Neurology
Providence, Rhode Island, United States, 02903
Actively Recruiting
26
Medical University of South Carolina, Movement Disorders Dept.
Charleston, South Carolina, United States, 29425
Actively Recruiting
27
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
28
UTHealth Houston Neurosciences - Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
29
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
30
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Actively Recruiting
31
EvergreenHealth - Research Department
Kirkland, Washington, United States, 98034
Actively Recruiting
32
NeuRA (Neuroscience Research Australia)
Randwick, New South Wales, Australia, 2031
Actively Recruiting
33
Gold Coast Hospital & Health Service
Southport, Queensland, Australia, 4215
Actively Recruiting
34
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
35
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
36
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
37
The Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Actively Recruiting
38
The University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z3
Actively Recruiting
39
University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
40
CHUM - Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
Research Team
P
Patient Engagement
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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