A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects with Parkinson's Disease
Purpose
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 5-6 study sites in North America
Condition
- Parkinson's Disease
Eligibility
- Eligible Ages
- Between 40 Years and 69 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
1. Men or women aged ≥ 40 and < 70 years with a clinically establisheddiagnosis of
Parkinson's disease in accordance with the Movement Disorder Society (MDS) Clinical
Diagnostic Criteria for Parkinson's Disease.
2. Subject has a diagnosis of PD for ≥ 5 years.
3. Subject has suboptimal control of PD symptoms, or intolerable side-effects with
optimized oral antiparkinsonian medication regimen for ≥ 3 months, including
treatment with L-DOPA and at least one medication that increases the effects of
L-DOPA .
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 medication 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 and the
Hauser patient daily diary.
8. Subject must meet the following ethnicity criteria:
- SS1 will either be Asian defined as having both parents and 4 grandparents who
are ethnically Asian, or non-Asian.
- SS2 and SS3 will be Asian defined as having both parents and 4 grandparents who
are ethnically Asian.
- Cohort 2 subjects will be of any ethnicity.
9. Subject is approved by the Sponsor Eligibility Committee following review of all
required information collected during Screening and prior to surgery on Day -1.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- The sentinel cohort of 3 subjects will be open-label and receive DSP-1083. Cohort 2 (20 subjects) will be randomized in a 1:1 ratio to receive either DSP-1083 during a surgical procedure, or sham surgery with no DSP-1083 administered.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental DSP-1083 |
Implantation of DSP-1083 (2.7M viable cells per hemisphere; 5.4M total cell dose) |
|
|
Sham Comparator 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. |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
Lexington, Kentucky 40536
More Details
- NCT ID
- NCT06753331
- Status
- Recruiting
- Sponsor
- Sumitomo Pharma America, Inc.
Detailed Description
This is a multicenter first-in-human (FIH) study designed to evaluate the safety, tolerability, and clinical responses following implantation of 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. SS1 Cohort 1 will receive 2 unilateral surgical procedures separated by approximately 28 weeks. SS2 and SS3 will undergobilateral implantation of DSP-1083 in a single surgical procedure.