Back to Clinical Trials
Phase 3Recruiting

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

Sponsored by BlueRock Therapeutics

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).

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 p…

Where this study is enrolling (34)

Show all 34 locations

  • UCLA NeuroTranslational Research Center

    Los Angeles, California

    I'm interested

  • University of Colorado Hospital - Neurology Clinic

    Aurora, Colorado

    I'm interested

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia

    I'm interested

  • Mayo Clinic Jacksonville - Neurology

    Jacksonville, Florida

    I'm interested

  • USF Parkinson's Disease and Movement Disorders Center

    Tampa, Florida

    I'm interested

  • University of Miami Health System - Neurology

    Miami, Florida

    I'm interested

  • Parkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital

    Chicago, Illinois

    I'm interested

  • Rush University Medical Center - Neurology

    Chicago, Illinois

    I'm interested

  • University of Kansas Medical Center

    Kansas City, Kansas

    I'm interested

  • University of Louisville Hospital

    Louisville, Kentucky

    I'm interested

  • Johns Hopkins Hospital - Neurology

    Baltimore, Maryland

    I'm interested

  • Tufts Medical Center - Neurology

    Boston, Massachusetts

    I'm interested

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts

    I'm interested

  • Quest Research Institute

    Farmington Hills, Michigan

    I'm interested

  • Michigan Clinical Research Unit - Neurology

    Ann Arbor, Michigan

    I'm interested

  • University of Michigan Clinical Research Unit - Neurology

    Ann Arbor, Michigan

    I'm interested

  • Mount Sinai West - Neurology

    New York, New York

    I'm interested

  • UBMD Neurology

    Buffalo, New York

    I'm interested

  • New York Presbyterian/Weill Cornell Medical Center

    New York, New York

    I'm interested

  • Duke Neurological Disorders Clinic

    Durham, North Carolina

    I'm interested

  • University of Toledo Medical Center

    Toledo, Ohio

    I'm interested

  • OHSU Neurology Clinic, South Waterfront

    Portland, Oregon

    I'm interested

  • Rhode Island Hospital - Neurology

    Providence, Rhode Island

    I'm interested

  • Medical University of South Carolina, Movement Disorders Dept.

    Charleston, South Carolina

    I'm interested

  • Vanderbilt University Medical Center

    Nashville, Tennessee

    I'm interested

  • UTHealth Houston Neurosciences - Texas Medical Center

    Houston, Texas

    I'm interested

  • University of Vermont Medical Center

    Burlington, Vermont

    I'm interested

  • Virginia Commonwealth University

    Richmond, Virginia

    I'm interested

  • EvergreenHealth - Research Department

    Kirkland, Washington

    I'm interested
Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.