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A Multicenter, Sham-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Clinical Responses Following Stereotactic Intracranial Implantation of DSP-1083 Into Subjects With Parkinson's Disease
Led by Sumitomo Pharma America, Inc. · Updated on 2026-03-02
25
Participants Needed
2
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and clinical responses of DSP-1083 implantation in people with Parkinson's disease. This multicenter, first-in-human study compares the effects of dopaminergic progenitor cells derived from induced pluripotent stem cells (DSP-1083) against sham surgery. The study evaluates safety through monitoring adverse events, changes in neuropsychiatric and cognitive status, and neuroimaging over a period of 104 weeks. Participants are randomly assigned to receive either DSP-1083 implants (2.7 million viable cells per hemisphere, totaling 5.4 million cells) or undergo a sham surgery involving partial thickness burr hole procedures without cell implantation. The first sentinel subject undergoes two unilateral surgeries about 28 weeks apart, while other subjects receive one bilateral surgery. The trial is quadruple-masked and conducted at multiple sites in the United States. During the study, participants will have regular assessments including clinical evaluations, cognition tests like the Montreal Cognitive Assessment and Mattis Dementia Rating Scale, and brain imaging such as MRI and fluorodopa uptake scans to monitor graft function and safety. Researchers will also track vital signs, laboratory tests, and any adverse events for up to 104 weeks. The study aims to understand how DSP-1083 affects Parkinson's symptoms and safety over two years.
CONDITIONS
Brief Title
A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects With Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 40 to 72 years at the time of informed consent with a clinically established diagnosis of Parkinson's disease according to Movement Disorder Society Clinical Diagnostic Criteria.
- Diagnosis of Parkinson's disease for at least 4 years.
- Suboptimal control of Parkinson's symptoms with a stable oral antiparkinsonian medication regimen including levodopa/carbidopa for at least 2 months prior to screening.
- L-DOPA response of at least 30% without influence of antiparkinsonian medications at screening.
- Modified Hoehn and Yahr stage 3 to 4 in the Off state.
- Pretreatment 18F-DOPA PET scan consistent with Parkinson's disease.
- Presence of both On and Off states as shown by MDS-UPDRS Part III/IV and Hauser patient daily diary.
- For sentinel subjects, 2 must be of Asian race with at least 2 grandparents who are Japanese, Taiwanese, Korean, or Chinese; other cohort subjects can be any race.
- Approval by Enrollment Authorization Eligibility Committee after screening review.
You will not qualify if you...
- Atypical parkinsonian syndromes such as progressive supranuclear palsy, multiple system atrophy, dementia with Lewy bodies, corticobasal degeneration, Parkinson-plus syndrome, vascular or secondary parkinsonism, hereditary parkinsonism.
- Non-Parkinson's neurological symptoms or brain diseases like tumor, inflammation, vascular disorders, cerebral hemorrhage, Alzheimer's disease, or other neurodegenerative disorders.
- Psychiatric symptoms, cognitive impairment, depression, dementia, or behavioral disorders that preclude participation.
- Previous treatments including deep-brain stimulation, CNS ablation, implanted cell or gene therapy, or focused ultrasound.
- Peak-dose dyskinesia severe enough to prevent participation as defined by UDysRS scoring.
- History or current abnormal immune function affecting implant engraftment or use of immunosuppressants.
- Abnormal lab test results including low neutrophil or platelet counts, elevated liver enzymes or bilirubin, reduced kidney function, or poorly controlled diabetes.
- Any disorder contraindicating general anesthesia, conscious sedation, or stereotactic surgery.
- Clinically significant unstable medical or chronic conditions posing risk or confounding study results.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure or 2 unilateral procedures separated by approximately 28 weeks depending on cohort assignment
Participants undergo stereotactic intracranial implantation of DSP-1083 cells or sham surgery.
1 or 2 surgery visits depending on cohort assignment
Duration - Up to 104 weeks
Participants are monitored for safety, tolerability, and clinical responses including neuropsychiatric assessments and neuroimaging over 104 weeks.
Regular visits for assessments during the 104-week follow-up period
Trial Site Locations
Total: 2 locations
1
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
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2
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, United States, 10032
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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