Status:
COMPLETED
Phase 1 Safety and Tolerability Study of MSK-DA01 Cell Therapy for Advanced Parkinson's Disease
Lead Sponsor:
BlueRock Therapeutics
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Conditions:
Advanced Parkinson's Disease
Eligibility:
All Genders
50-78 years
Phase:
PHASE1
Brief Summary
This clinical trial is designed to test whether surgically injecting nerve cells that make dopamine into the brain of Parkinson's disease patients is safe, and to monitor for potential side effects.
Detailed Description
Subjects will undergo surgical transplantation of the dopamine-producing cells under general anesthesia into a part of the brain called the putamen. Subjects then take medicines to partially suppress ...
Eligibility Criteria
Inclusion
- Age 50-78 years old (Canada)
- Age 60-78 years old (United States)
- Diagnosis of Parkinson's Disease made between 3 to 20 years ago
- Taking levodopa, but with complications of therapy such as wearing off and/or dyskinesia
- Able to participate in all study visits and evaluations, including brain MRI and PET scan
- Existence of a study partner who may act as potential surrogate over long term for ongoing consent
Exclusion
- Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis or other neurodegenerative diseases such as Alzheimer's disease
- Prior Deep Brain Stimulation , lesion therapy, or gene therapy for PD
- Prior surgical or radiation therapy to the brain or spinal cord
- Any medical condition resulting in high risk of immunosuppressive drugs, including any active infectious disease
- Inability to temporarily stop anti-platelet agents or other anti-coagulant medications without serious risk
- Previous or currently active malignant disease within the past 5 years, except basal cell carcinoma or in situ uterine cervical carcinoma that have been treated
- Severe obesity (\>350 lbs) or any condition that prevents use of PET/MRI
- Pregnancy or breastfeeding
- Contraindication to surgery or general anesthesia
- In the opinion of the investigator, any other condition regarded as making subject unsuitable for trial
Key Trial Info
Start Date :
May 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04802733
Start Date
May 3 2021
End Date
June 10 2024
Last Update
November 1 2024
Active Locations (3)
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1
University of California Irvine
Orange, California, United States, 92868
2
Weill Cornell Medical College
New York, New York, United States, 10065
3
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8