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
BlueRock Therapeutics
Summary
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).
Description
The BRT-DA01-301 study is a Phase 3, multicenter, randomized, sham surgery-controlled, double-blind study involving approximately 102 participants with Parkinson's Disease (PD). Participants will be randomized in a 2:1 ratio to either receive bemdaneprocel or undergo sham surgery. The study includes an immunosuppression regimen and placebo equivalents to maintain blinding. The primary objective is to evaluate the efficacy of bemdaneprocel on motor symptoms in participants with PD. The secondary objective is to evaluate the effects of bemdaneprocel on Motor function, Quality of life, Non-motor…
Eligibility
- Age range
- 45–75 years
- Sex
- All
- Healthy volunteers
- No
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 Exc…
Interventions
- Biologicalbemdaneprocel
Investigational cell therapy comprising midbrain dopaminergic neuron progenitors derived from human embryonic stem cells
- ProcedureSham surgery
Sham surgery will be performed on Day 0
Locations (39)
- Banner Sun Health Research InstituteSun City, Arizona
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- UCLA NeuroTranslational Research CenterLos Angeles, California
- UCI Medical Center - NeurologyOrange, California
- University of Colorado Hospital - Neurology ClinicAurora, Colorado
- MedStar Georgetown University HospitalWashington D.C., District of Columbia