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).
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
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
BlueRock Therapeutics
Lead sponsor
Bayer
Collaborator