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RecruitingPhase 3

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

BlueRock Therapeutics · with Bayer · NCT06944522

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 45–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
102
US sites recruiting
34
Study start
June 17, 2025
Record last updated
August 4, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: bemdaneprocel; Sham surgery

Conditions: Parkinsons Disease (PD)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Mayo Clinic Scottsdale - Neurology

    Scottsdale, AZ 85259

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • Banner Sun Health Research Institute

    Sun City, AZ 85351

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • University of Arkansas for Medical Sciences

    Little Rock, AR 72205

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • UCLA NeuroTranslational Research Center

    Los Angeles, CA 90095

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • UCI Medical Center - Neurology

    Orange, CA 92868

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • Stanford Neuroscience Health Center

    Palo Alto, CA 94304

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • University of Colorado Hospital - Neurology Clinic

    Aurora, CO 80045

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • MedStar Georgetown University Hospital

    Washington D.C., DC 20007

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • Mayo Clinic Jacksonville - Neurology

    Jacksonville, FL 32224

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • University of Miami Health System - Neurology

    Miami, FL 33136

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • USF Parkinson's Disease and Movement Disorders Center

    Tampa, FL 33613

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

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

    Chicago, IL 60611

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • Rush University Medical Center - Neurology

    Chicago, IL 60612

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • University of Kansas Medical Center

    Kansas City, KS 66160-8500

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • University of Louisville Hospital

    Louisville, KY 40202

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • Johns Hopkins Hospital - Neurology

    Baltimore, MD 21287

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • Tufts Medical Center - Neurology

    Boston, MA 02111

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • Beth Israel Deaconess Medical Center

    Boston, MA 02215

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • Michigan Clinical Research Unit - Neurology

    Ann Arbor, MI 48109

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • University of Michigan Clinical Research Unit - Neurology

    Ann Arbor, MI 48109

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • Quest Research Institute

    Farmington Hills, MI 48334

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • UBMD Neurology

    Buffalo, NY 14221

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • Mount Sinai West - Neurology

    New York, NY 10019

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • New York Presbyterian/Weill Cornell Medical Center

    New York, NY 10065

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • Duke Neurological Disorders Clinic

    Durham, NC 27710

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • University of Toledo Medical Center

    Toledo, OH 43614

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • OHSU Neurology Clinic, South Waterfront

    Portland, OR 97239

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • Rhode Island Hospital - Neurology

    Providence, RI 02903

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • Medical University of South Carolina, Movement Disorders Dept.

    Charleston, SC 29425

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • Vanderbilt University Medical Center

    Nashville, TN 37232

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • UTHealth Houston Neurosciences - Texas Medical Center

    Houston, TX 77030

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • University of Vermont Medical Center

    Burlington, VT 05401

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • Virginia Commonwealth University

    Richmond, VA 23284

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

  • EvergreenHealth - Research Department

    Kirkland, WA 98034

    Site contact: Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com

Study contacts (from the official record)

  • Patient Engagement · 1-877-380-3967 · clinicaltrials@bluerocktx.com
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A Study to Investigate the Efficacy and Safety of Bemdaneprocel in… (NCT06944522) | Bored Studies