RecruitingPhase 3

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

AZ

CA

CO

DC

FL

IL

KS

KY

MA

MD

MI

NC

NY

OH

OR

RI

SC

TN

TX

VA

VT

WA