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A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease

RecruitingPhase 3

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

Who can join

Ages 45 to 75 · All sexes

Full eligibility criteria
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

About the study

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 is being tested

Sponsor: BlueRock Therapeutics · Participants: 102 · Started: Jun 17, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06944522

Locations in the U.S.

ArizonaMayo Clinic Scottsdale - Neurology, Scottsdale
Banner Sun Health Research Institute, Sun City
ArkansasUniversity of Arkansas for Medical Sciences, Little Rock
CaliforniaUCLA NeuroTranslational Research Center, Los Angeles
UCI Medical Center - Neurology, Orange
Stanford Neuroscience Health Center, Palo Alto
ColoradoUniversity of Colorado Hospital - Neurology Clinic, Aurora
District of ColumbiaMedStar Georgetown University Hospital, Washington D.C.
FloridaMayo Clinic Jacksonville - Neurology, Jacksonville
University of Miami Health System - Neurology, Miami
USF Parkinson's Disease and Movement Disorders Center, Tampa
IllinoisParkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital, Chicago
Rush University Medical Center - Neurology, Chicago
KansasUniversity of Kansas Medical Center, Kansas City
KentuckyUniversity of Louisville Hospital, Louisville
MarylandJohns Hopkins Hospital - Neurology, Baltimore
MassachusettsBeth Israel Deaconess Medical Center, Boston
Tufts Medical Center - Neurology, Boston
MichiganMichigan Clinical Research Unit - Neurology, Ann Arbor
University of Michigan Clinical Research Unit - Neurology, Ann Arbor
Quest Research Institute, Farmington Hills
New YorkUBMD Neurology, Buffalo
Mount Sinai West - Neurology, New York
New York Presbyterian/Weill Cornell Medical Center, New York
North CarolinaDuke Neurological Disorders Clinic, Durham
OhioUniversity of Toledo Medical Center, Toledo
OregonOHSU Neurology Clinic, South Waterfront, Portland
Rhode IslandRhode Island Hospital - Neurology, Providence
South CarolinaMedical University of South Carolina, Movement Disorders Dept., Charleston
TennesseeVanderbilt University Medical Center, Nashville
TexasUTHealth Houston Neurosciences - Texas Medical Center, Houston
VermontUniversity of Vermont Medical Center, Burlington
VirginiaVirginia Commonwealth University, Richmond
WashingtonEvergreenHealth - Research Department, Kirkland

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.