A Study To Investigate The Efficacy And Safety Of Bemdaneprocel In Adults Who Have Parkinson's Disease

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Individual of any sex ≥45 to ≤75 years of age at informed consent
2. Diagnosis of clinically established PD
3. ≥4 and \<12 years from time of PD diagnosis at informed consent
4. Must demonstrate responsiveness to levodopa therapy
5. Receiving medical therapy for the treatment of PD symptoms
6. ≥2.5 hours of daily OFF-time

Exclusion Criteria:

1. PD presenting with recurrent falls
2. 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
3. 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
4. History of gene therapy or cell therapy
5. Prior surgical or radiation therapy to the brain, including deep brain stimulation (DBS) and lesion therapy, or prior history of intradural spinal cord surgery
6. Contraindication to surgery, general anesthesia, cell therapy, immunosuppression, or other required drugs
7. Current or previously active malignant disease within the past 5 years
8. Chronic immunosuppressive therapy
9. Receipt of another investigational therapy
10. Pregnancy or breastfeeding

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Erika Driver-Dunckley, M.D.

Contact us for the latest status

Contact information:

Erica Boyd

4803421316

boyd.erica@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Ryan Uitti, M.D.

Contact us for the latest status

Contact information:

Audrey Strongosky

strongosky.audrey2@mayo.edu

More information

Publications

Publications are currently not available