NCT06753331 · Sumitomo Pharma America, Inc.
A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects With Parkinson's Disease
What this study is about
The Goal of this study is to evaluate the safety, tolerability, and clinical responses following implantation of DSP-1083. Study enrolls both male and female patients in 2 cohorts.
View original scientific description
The Goal of this study is to evaluate the safety, tolerability, and clinical responses following implantation of DSP-1083. Study enrolls both male and female patients in 2 cohorts.
Interventions
COMBINATION_PRODUCT
DSP-1083 implantation
DSP-1083 subjects will receive 2.7M viable cells per hemisphere; 5.4M total cell dose as implants.
PROCEDURE
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.
Primary outcome measures
Incidence and severity of Adverse Events.
Time frame: Up to 104 weeks
Incidence of Serious Adverse Events (SAE).
Time frame: Up to 104 weeks
Incidence and severity of Adverse Events of Special Interest (AESI).
Time frame: Up to 104 weeks
Incidence and severity of Adverse Events leading to study discontinuation.
Time frame: Up to 104 weeks
Change from baseline in cognition and neuropsychiatric status as assessed by Montreal Cognitive Assessment (MoCA).
Time frame: Up to 104 weeks
The MoCA is a widely used, sensitive, validated screening test for detecting mild cognitive impairment and can also predict the presence of cognitive deterioration (ie, progression from mild cognitive impairment to dementia) in PD patients.
Change from baseline in cognition and neuropsychiatric status as assessed by Mattis Dementia Rating Scale (MDRS).
Time frame: Up to 104 weeks
The MDRS has been utilized for early detection of dementia, differential diagnosis between Alzheimer's disease and other dementias. The 144-point scale is an aggregate score of 5 subscales: attention, initiation/perseveration (I/P), construction, conceptualization, and memory.The total score ranges from 0 to 144, with lower scores indicating greater cognitive impairment.
Change from baseline in Head Magnetic Resonance Imaging (MRI) (graft expansion/rejection) neuroimaging parameters.
Time frame: Up to 104 weeks
Safety MRIs - are conducted to assess the safety of DSP-1083 including rejection, abnormal growth, and formation of mass lesions, which could indicate teratoma formation
Change from baseline in Fluorodopa (F-DOPA) uptake (graft function) neuroimaging parameters.
Time frame: Up to 104 weeks
PET scans using F-DOPA will be performed at Screening and then post-surgery to follow the course of graft development and to provide a measure of dopaminergic nerve terminals in the striatum.
Frequency of subjects with suicidal ideation or suicidal behavior using the Columbia Suicide Severity Scale (C-SSRS).
Time frame: Up to 104 weeks
Observed values and change from baseline in clinical laboratory tests.
Time frame: Up to 104 weeks
Laboratory results at each time point will be summarized using descriptive statistics (mean, standard deviation (SD), median, minimum, and maximum) by treatment group.
Observed values and change from baseline in Heart Rate (HR).
Time frame: Up to 104 weeks
12-lead ECG parameters ventricular HR at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in QT interval.
Time frame: Up to 104 weeks
12-lead ECG parameters QT interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in PR interval.
Time frame: Up to 104 weeks
12-lead ECG parameters PR interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in QRS duration.
Time frame: Up to 104 weeks
12-lead ECG parameters QRS duration at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in RR interval.
Time frame: Up to 104 weeks
12-lead ECG parameters RR interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in QTcF interval.
Time frame: Up to 104 weeks
12-lead ECG parameters QTcF interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in body temperature.
Time frame: Up to 104 weeks
Vital signs parameter body temperature will be summarized using descriptive statistics at each time point by treatment group.
Observed values and change from baseline in respiratory rate.
Time frame: Up to 104 weeks
Vital signs parameter supine respiratory rate will be summarized using descriptive statistics at each time point by treatment group.
Observed values and change from baseline in pulse rate.
Time frame: Up to 104 weeks
Vital signs parameter supine and standing pulse will be summarized using descriptive statistics at each time point by treatment group.
Observed values and change from baseline in Systolic Blood Pressure.
Time frame: Up to 104 weeks
Vital signs parameter Systolic Blood Pressure will be summarized using descriptive statistics at each time point by treatment group.
Observed values and change from baseline in Diastolic Blood Pressure.
Time frame: Up to 104 weeks
Vital signs parameter Diastolic Blood Pressure will be summarized using descriptive statistics at each time point by treatment group.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Men or women aged ≥ 40 and ≤ 72 years at the time of informed consent with a clinically established diagnosis of Parkinson's disease in accordance with the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease.
- Subject has a clinically established diagnosis of PD for ≥ 4 years.
- 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.
- Subject has a L-DOPA response of ≥ 30% without the influence of antiparkinsonian medications at Screening.
- Subject has a Modified Hoehn and Yahr stage 3 - 4 in the Off state.
- Subject has a pretreatment 18F-DOPA PET scan consistent with PD.
- Subject has both On and Off states as demonstrated by the MDS-UPDRS Part III/IV and the Hauser patient daily diary.
- 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.
- Subject is approved by the Enrollment Authorization Eligibility Committee following review of all required information collected during Screening.
Exclusion criteria
- Subject has atypical parkinsonian syndrome (eg, progressive supranuclear palsy \[PSP\], multiple system atrophy \[MSA\], dementia with Lewy bodies \[DLB\], corticobasal degeneration, Parkinson-plus syndrome, vascular parkinsonism, secondary parkinsonism, hereditary parkinsonism).
- 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.
- Subject has psychiatric symptoms, cognitive impairment, depression, dementia, or other behavioral disorder that would preclude study participation based on Investigator decision.
- 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.
- 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.
- 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.
- 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).
- Subject has any disorder that would contraindicate general anesthesia, conscious sedation or stereotactic surgery.
- 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.
Where
- Lexington, Kentucky
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 2, 2026 · Source of record for eligibility and locations