Reduce daily off medication time
- Trial ID
- NCT06944522
- 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
- Goal
- Reduce daily off medication time
- Phase
- PHASE3
- Status
- RECRUITING
- Sponsor
- BlueRock Therapeutics
- Study Type
- INTERVENTIONAL
- Enrollment
- 102 participants
- Conditions
- Parkinsons Disease (PD)
- Interventions
- bemdaneprocel, Sham surgery
Plain-Language Summary
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.
Locations
- Banner Sun Health Research Institute, Sun City, Arizona, United States
- University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
- UCLA NeuroTranslational Research Center, Los Angeles, California, United States
- University of Colorado Hospital - Neurology Clinic, Aurora, Colorado, United States
- MedStar Georgetown University Hospital, Washington D.C., District of Columbia, United States
- University of Miami Health System - Neurology, Miami, Florida, United States
- USF Parkinson's Disease and Movement Disorders Center, Tampa, Florida, United States
- Parkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital, Chicago, Illinois, United States
- University of Kansas Medical Center, Kansas City, Kansas, United States
- University of Louisville Hospital, Louisville, Kentucky, United States
- Johns Hopkins Hospital - Neurology, Baltimore, Maryland, United States
- Tufts Medical Center - Neurology, Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
- Michigan Clinical Research Unit - Neurology, Ann Arbor, Michigan, United States
- University of Michigan Clinical Research Unit - Neurology, Ann Arbor, Michigan, United States
- Quest Research Institute, Farmington Hills, Michigan, United States
- UBMD Neurology, Buffalo, New York, United States
- Mount Sinai West - Neurology, New York, New York, United States
- New York Presbyterian/Weill Cornell Medical Center, New York, New York, United States
- University of Toledo Medical Center, Toledo, Ohio, United States
And 17 more locations.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying bemdaneprocel. 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.
- Who can participate?
- Participants must be between 45 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 37 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 3 trial is estimated to last approximately 1 year and 8 months.