Overview
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
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.
Eligibility
- 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.
- Subject has a diagnosis of PD for ≥ 5 years.
- 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 .
- 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 medication 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 and the
Hauser patient daily diary.
- 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.