A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects With Parkinson's Disease
NCT ID: NCT06753331
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2024-12-18
2030-12-15
Brief Summary
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Detailed Description
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Cohort 1 sentinel subject (SS1) will undergo 2 unilateral surgical procedures separated by approximately 28 weeks, whereas SS2 and all subsequent subjects will undergo 1 bilateral surgical procedure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DSP-1083
Implantation of DSP-1083 (2.7M viable cells per hemisphere; 5.4M total cell dose)
DSP-1083 implantation
DSP-1083 subjects will receive 2.7M viable cells per hemisphere; 5.4M total cell dose as implants.
Sham Surgery
Sham surgery subjects will undergo a partial thickness burr hole surgical procedure on each side of the skull with no DSP-1083 administration.
Sham surgery treatment
Sham surgery subjects will undergo a partial thickness burr hole surgical procedure on each side of the skull with no DSP-1083 administration.
Interventions
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DSP-1083 implantation
DSP-1083 subjects will receive 2.7M viable cells per hemisphere; 5.4M total cell dose as implants.
Sham surgery treatment
Sham surgery subjects will undergo a partial thickness burr hole surgical procedure on each side of the skull with no DSP-1083 administration.
Eligibility Criteria
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Inclusion Criteria
2. Subject has a clinically established diagnosis of PD for ≥ 4 years.
3. Subject has suboptimal control of PD symptoms, with optimized oral antiparkinsonian medication regimen including levodopa/carbidopa monotherapy or levodopa/carbidopa plus antiparkinsonian medications, with stable dosing for ≥ 2months prior to screening.
4. Subject has a L-DOPA response of ≥ 30% without the influence of antiparkinsonian medications at Screening.
5. Subject has a Modified Hoehn and Yahr stage 3 - 4 in the Off state.
6. Subject has a pretreatment 18F-DOPA PET scan consistent with PD.
7. Subject has both On and Off states as demonstrated by the MDS-UPDRS Part III/IV and the Hauser patient daily diary.
8. Subjects must meet the following race criteria: 2 of the up to 5 sentinel subjects will be of Asian race, defined as having at least 2 grandparents who are Japanese, Taiwanese, Korean, or Chinese. Subjects in Cohort 2 can be of any race.
9. Subject is approved by the Enrollment Authorization Eligibility Committee following review of all required information collected during Screening.
Exclusion Criteria
2. Subject has non-PD neurological symptoms or evidence of non-PD brain disease (eg, tumor, inflammation, active or history of vascular disorder, history of cerebral hemorrhage, Alzheimer's disease, or other neurodegenerative disorder) based on neuroimaging and/or medical history that would preclude study participation.
3. Subject has psychiatric symptoms, cognitive impairment, depression, dementia, or other behavioral disorder that would preclude study participation based on Investigator decision.
4. Subject has received previous striatal or other extrapyramidal system PD treatments, including deep-brain stimulation, central nervous system (CNS) ablation (eg, pallidotomy, thalamotomy), implanted cell, or gene therapy, and/or focused ultrasound therapy.
5. Subject has peak-dose dyskinesia of sufficient severity that precludes study participation, defined as any item score of ≥ 3 (moderate dyskinesia) on the UDysRS Part 1B (Patient Dyskinesia Questionnaire) AND/OR any item score of ≥ 2 (moderate dyskinesia) on Part 3 (Objective Evaluation of Dyskinesia Disability) Intensity Scale: Impairment. Subject has another type (eg, diphasic dyskinesia) or an unusual pattern of dyskinesia.
6. Subject has a history of, or concurrent abnormal immune function that may adversely affect the engraftment of the cell implants and use of adjunctive immunosuppressants.
7. The subject has the following clinical laboratory test results at Screening:
* Neutrophil count \< 2,000/μL.
* Platelet count \< 5.0 × 104/μL.
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 3.0 × upper limit of normal.
* Total bilirubin \> 1.5 × upper limit of normal.
* Persistent estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2.
* Poorly controlled blood glucose in diabetic subjects (glycosylated hemoglobin \> 9.0%, or fasting serum glucose ≥ 200mg/dL).
8. Subject has any disorder that would contraindicate general anesthesia, conscious sedation or stereotactic surgery.
9. Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that would pose a risk to the subject or that might confound the results of the study. In cases in which the impact of the condition upon risk to subject or study results is unclear, the Medical Monitor should be consulted.
40 Years
69 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Kentucky Medical Center
Lexington, Kentucky, United States
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, United States
Countries
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Facility Contacts
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Other Identifiers
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DD201101
Identifier Type: -
Identifier Source: org_study_id
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