Neuronal Cell Therapy in PD

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 symptoms of PD, disease severity, and use of PD medications or therapies compared with participants who undergo sham surgery. Participants will be followed for at least 18 months in the double-blind period and up to five years if they receive bemdaneprocel.

In order to participate you must meet the following criteria:

• Have a diagnosis of clinically established PD as defined by the International Parkinson and Movement Disorders Society.
• Are male or female and ≥45 to ≤75 years of age at informed consent.
• Have had robust and clear response to DA therapy as defined by MDS-UPDRS Part III.
• has been ≥4 and <12 years from time of PD diagnosis at informed consent.
• Demonstrate responsiveness to levodopa therapy.
• Are receiving medical therapy for the treatment of PD symptoms.
• Have ≥2.5 hours of daily OFF-time.
• Have been vaccinated per current national guidelines or local practice for patients with altered immunocompetence.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.