bemdaneprocel for Parkinson's (NCT06944522)
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
- Stanford Neuroscience Health Center, Palo Alto, 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
- Mayo Clinic Jacksonville - Neurology, Jacksonville, Florida, 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
- Rush University Medical Center - Neurology, 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
And 22 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 42 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 3 trial is estimated to last approximately 1 year and 8 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Surgical procedure (invasive). Confirm the full schedule with the study coordinator.