--- title: Reduce daily off medication time nct_id: NCT06944522 phase: PHASE3 status: RECRUITING sponsor: BlueRock Therapeutics study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT06944522" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06944522" last_fetched: "2026-05-10T14:03:05.216Z" source: "Parkinson's Pathways (curated)" --- # Reduce daily off medication time **Goal (in five words):** Reduce daily off medication time **Official Title:** 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 **Trial ID:** [NCT06944522](https://clinicaltrials.gov/study/NCT06944522) ## Key Facts - **Phase:** PHASE3 - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** BlueRock Therapeutics - **Target Enrollment:** 102 participants - **Start Date:** 2025-06-17 - **Completion Date:** 2027-03 - **Conditions:** Parkinsons Disease (PD) - **Interventions:** bemdaneprocel, Sham surgery - **Intervention Types:** BIOLOGICAL, PROCEDURE ## Summary For Families The goal is to replace lost midbrain dopamine neurons to reduce OFF-time and improve motor control in people with Parkinson's who still respond well to levodopa. The approach uses bemdaneprocel, dopamine-producing cells implanted into the midbrain to restore dopamine signaling, compared to a sham surgery control, with close imaging and immune monitoring because the new cells may require immunosuppression. Eligible volunteers are 45 to 75 years old, diagnosed 4 to under 12 years ago, on PD medications, have a robust levodopa response, and experience at least 2.5 hours of daily OFF-time. People with prior brain surgery or prior cell/gene therapy, recurrent falls or other neurological diseases, active infections, recent cancer, or who cannot safely have surgery or immunosuppression are excluded. ## Eligibility - **Minimum age:** 45 Years - **Maximum age:** 75 Years - **Sex:** ALL ### 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 ``` ## Locations (39) - Banner Sun Health Research Institute, Sun City, Arizona, United States _(33.5975, -112.2718)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States _(34.7465, -92.2896)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - UCLA NeuroTranslational Research Center, Los Angeles, California, United States _(34.0522, -118.2437)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - UCI Medical Center - Neurology, Orange, California, United States _(33.7878, -117.8531)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - University of Colorado Hospital - Neurology Clinic, Aurora, Colorado, United States _(39.7294, -104.8319)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - MedStar Georgetown University Hospital, Washington D.C., District of Columbia, United States _(38.8951, -77.0364)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - University of Miami Health System - Neurology, Miami, Florida, United States _(25.7743, -80.1937)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - USF Parkinson's Disease and Movement Disorders Center, Tampa, Florida, United States _(27.9475, -82.4584)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - Parkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital, Chicago, Illinois, United States _(41.8500, -87.6500)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - University of Kansas Medical Center, Kansas City, Kansas, United States _(39.1142, -94.6275)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - University of Louisville Hospital, Louisville, Kentucky, United States _(38.2542, -85.7594)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - Johns Hopkins Hospital - Neurology, Baltimore, Maryland, United States _(39.2904, -76.6122)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - Tufts Medical Center - Neurology, Boston, Massachusetts, United States _(42.3584, -71.0598)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States _(42.3584, -71.0598)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - Michigan Clinical Research Unit - Neurology, Ann Arbor, Michigan, United States _(42.2776, -83.7409)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - University of Michigan Clinical Research Unit - Neurology, Ann Arbor, Michigan, United States _(42.2776, -83.7409)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - Quest Research Institute, Farmington Hills, Michigan, United States _(42.4853, -83.3772)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - UBMD Neurology, Buffalo, New York, United States _(42.8865, -78.8784)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - Mount Sinai West - Neurology, New York, New York, United States _(40.7143, -74.0060)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - New York Presbyterian/Weill Cornell Medical Center, New York, New York, United States _(40.7143, -74.0060)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - Duke Neurological Disorders Clinic, Durham, North Carolina, United States _(35.9940, -78.8986)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - University of Toledo Medical Center, Toledo, Ohio, United States _(41.6639, -83.5552)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - OHSU Neurology Clinic, South Waterfront, Portland, Oregon, United States _(45.5234, -122.6762)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - Rhode Island Hospital - Neurology, Providence, Rhode Island, United States _(41.8240, -71.4128)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - Medical University of South Carolina, Movement Disorders Dept., Charleston, South Carolina, United States _(32.7763, -79.9327)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - Vanderbilt University Medical Center, Nashville, Tennessee, United States _(36.1659, -86.7844)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - UTHealth Houston Neurosciences - Texas Medical Center, Houston, Texas, United States _(29.7633, -95.3633)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - University of Vermont Medical Center, Burlington, Vermont, United States _(44.4759, -73.2121)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - Virginia Commonwealth University, Richmond, Virginia, United States _(37.5538, -77.4603)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - EvergreenHealth - Research Department, Kirkland, Washington, United States _(47.6815, -122.2087)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - NeuRA (Neuroscience Research Australia), Randwick, New South Wales, Australia _(-33.9144, 151.2490)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - Gold Coast Hospital & Health Service, Southport, Queensland, Australia _(-27.9672, 153.3980)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - Princess Alexandra Hospital, Woolloongabba, Queensland, Australia _(-27.4886, 153.0366)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - Monash Medical Centre, Clayton, Victoria, Australia _(-37.9167, 145.1167)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - The Alfred Hospital, Melbourne, Victoria, Australia _(-37.8140, 144.9633)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - The Royal Melbourne Hospital, Parkville, Victoria, Australia _(-37.7833, 144.9500)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - The University of British Columbia, Vancouver, British Columbia, Canada _(49.2497, -123.1193)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - University Health Network - Toronto Western Hospital, Toronto, Ontario, Canada _(43.7064, -79.3986)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com - CHUM - Centre hospitalier de l'Université de Montréal, Montreal, Quebec, Canada _(45.5088, -73.5878)_ - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com ## Central Contacts - Patient Engagement — (CONTACT) — 1-877-380-3967 — clinicaltrials@bluerocktx.com --- *Canonical: https://parkinsonspathways.com/trial/NCT06944522* *HTML version: https://parkinsonspathways.com/trial/NCT06944522* *Source data: https://clinicaltrials.gov/study/NCT06944522*