A Phase 1/2 interventional study of DSP-1083 implantation and Sham surgery treatment in Parkinson's Disease, sponsored by Sumitomo Pharma America, Inc.. Recruiting at 3 sites in United States. Open to participants aged 40 Years to 72 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Sumitomo Pharma America, Inc. (part of Sumitomo Pharma Co., Ltd.) · Phase 1/2, Interventional, and Treatment
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. This study will be held in approximately 5-8 study sites in United States
This is a multicenter first-in-human (FIH) study designed to evaluate the safety, tolerability, and clinical responses following implantation of dopaminergic progenitor cells derived from induced pluripotent stem cells (DSP-1083) compared with sham surgery. Safety is measured based on adverse events, changes in neuropsychiatric/cognition status, and serial neuroimaging (ie, engraftment status, graft expansion, rejection) over 104 weeks.
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 25 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Sumitomo Pharma America, Inc. is the lead sponsor of 181 studies on the registry; 5 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 21 (64%) have results posted.
First submitted after Sumitomo Pharma America, Inc. became part of Sumitomo Pharma Co., Ltd..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The subject has the following clinical laboratory test results at Screening:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implantation of DSP-1083 (2.7M viable cells per hemisphere; 5.4M total cell dose)
Combination Product: DSP-1083 implantation
Sham surgery subjects will undergo a partial thickness burr hole surgical procedure on each side of the skull with no DSP-1083 administration.
Procedure: Sham surgery treatment
DSP-1083 subjects will receive 2.7M viable cells per hemisphere; 5.4M total cell dose as implants.
Sham surgery subjects will undergo a partial thickness burr hole surgical procedure on each side of the skull with no DSP-1083 administration.
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).
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.
Time frame: Up to 104 weeks
Change from baseline in cognition and neuropsychiatric status as assessed by Mattis Dementia Rating Scale (MDRS).
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.
Time frame: Up to 104 weeks
Change from baseline in Head Magnetic Resonance Imaging (MRI) (graft expansion/rejection) neuroimaging parameters.
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
Time frame: Up to 104 weeks
Change from baseline in Fluorodopa (F-DOPA) uptake (graft function) neuroimaging parameters.
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.
Time frame: Up to 104 weeks
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.
Laboratory results at each time point will be summarized using descriptive statistics (mean, standard deviation (SD), median, minimum, and maximum) by treatment group.
Time frame: Up to 104 weeks
Observed values and change from baseline in Heart Rate (HR).
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.
Time frame: Up to 104 weeks
Observed values and change from baseline in QT interval.
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.
Time frame: Up to 104 weeks
Observed values and change from baseline in PR interval.
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.
Time frame: Up to 104 weeks
Observed values and change from baseline in QRS duration.
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.
Time frame: Up to 104 weeks
Observed values and change from baseline in RR interval.
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.
Time frame: Up to 104 weeks
Observed values and change from baseline in QTcF interval.
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.
Time frame: Up to 104 weeks
Observed values and change from baseline in body temperature.
Vital signs parameter body temperature will be summarized using descriptive statistics at each time point by treatment group.
Time frame: Up to 104 weeks
Observed values and change from baseline in respiratory rate.
Vital signs parameter supine respiratory rate will be summarized using descriptive statistics at each time point by treatment group.
Time frame: Up to 104 weeks
Observed values and change from baseline in pulse rate.
Vital signs parameter supine and standing pulse will be summarized using descriptive statistics at each time point by treatment group.
Time frame: Up to 104 weeks
Observed values and change from baseline in Systolic Blood Pressure.
Vital signs parameter Systolic Blood Pressure will be summarized using descriptive statistics at each time point by treatment group.
Time frame: Up to 104 weeks
Observed values and change from baseline in Diastolic Blood Pressure.
Vital signs parameter Diastolic Blood Pressure will be summarized using descriptive statistics at each time point by treatment group.
Time frame: Up to 104 weeks
Started Dec 2024 (actual). Primary completion is estimated for Dec 2030, 71 months after the start.
Of 55 phase 1/2 interventional studies under Parkinson Disease, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 53. This study's planned 71 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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