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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 45 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 years
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will be followed for at least 18 months in the double-blind period and up to five years if they receive bemdaneprocel."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this 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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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
Study sites (34)
AR
- University of Arkansas for Medical Sciences · Little Rock, AR 72205Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Little Rock
AZ
- Mayo Clinic Scottsdale - Neurology · Scottsdale, AZ 85259Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Scottsdale
- Banner Sun Health Research Institute · Sun City, AZ 85351Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Sun City
CA
- UCLA NeuroTranslational Research Center · Los Angeles, CA 90095Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Los Angeles
- UCI Medical Center - Neurology · Orange, CA 92868Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Orange
- Stanford Neuroscience Health Center · Palo Alto, CA 94304Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Palo Alto
CO
- University of Colorado Hospital - Neurology Clinic · Aurora, CO 80045Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Aurora
DC
- MedStar Georgetown University Hospital · Washington D.C., DC 20007Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Washington D.C.
FL
- Mayo Clinic Jacksonville - Neurology · Jacksonville, FL 32224Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Jacksonville
- University of Miami Health System - Neurology · Miami, FL 33136Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Miami
- USF Parkinson's Disease and Movement Disorders Center · Tampa, FL 33613Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Tampa
IL
- Parkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital · Chicago, IL 60611Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Chicago
- Rush University Medical Center - Neurology · Chicago, IL 60612Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Chicago
KS
- University of Kansas Medical Center · Kansas City, KS 66160-8500Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Kansas City
KY
- University of Louisville Hospital · Louisville, KY 40202Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Louisville
MA
- Tufts Medical Center - Neurology · Boston, MA 02111Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Boston
- Beth Israel Deaconess Medical Center · Boston, MA 02215Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Boston
MD
- Johns Hopkins Hospital - Neurology · Baltimore, MD 21287Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Baltimore
MI
- Michigan Clinical Research Unit - Neurology · Ann Arbor, MI 48109Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Ann Arbor
- University of Michigan Clinical Research Unit - Neurology · Ann Arbor, MI 48109Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Ann Arbor
- Quest Research Institute · Farmington Hills, MI 48334Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Farmington Hills
NC
- Duke Neurological Disorders Clinic · Durham, NC 27710Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Durham
NY
- UBMD Neurology · Buffalo, NY 14221Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Buffalo
- Mount Sinai West - Neurology · New York, NY 10019Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in New York
- New York Presbyterian/Weill Cornell Medical Center · New York, NY 10065Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in New York
OH
- University of Toledo Medical Center · Toledo, OH 43614Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Toledo
OR
- OHSU Neurology Clinic, South Waterfront · Portland, OR 97239Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Portland
RI
- Rhode Island Hospital - Neurology · Providence, RI 02903Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Providence
SC
- Medical University of South Carolina, Movement Disorders Dept. · Charleston, SC 29425Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Charleston
TN
- Vanderbilt University Medical Center · Nashville, TN 37232Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Nashville
TX
- UTHealth Houston Neurosciences - Texas Medical Center · Houston, TX 77030Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Houston
VA
- Virginia Commonwealth University · Richmond, VA 23284Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Richmond
VT
- University of Vermont Medical Center · Burlington, VT 05401Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Burlington
WA
- EvergreenHealth - Research Department · Kirkland, WA 98034Patient Engagement · Study contact · 1-877-380-3967 · clinicaltrials@bluerocktx.comMore trials in Kirkland