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
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.
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
- UCI Medical Center - Neurology, Orange, 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
And 19 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 39 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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.