A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects With Parkinson's Disease

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Sumitomo Pharma America, Inc.
Study ID
NCT06753331
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 72 Years
Healthy Volunteers
Not accepted

Interventions

  • DSP-1083 implantation — COMBINATION_PRODUCT
    DSP-1083 subjects will receive 2.7M viable cells per hemisphere; 5.4M total cell dose as implants.
  • Sham surgery treatment — PROCEDURE
    Sham surgery subjects will undergo a partial thickness burr hole surgical procedure on each side of the skull with no DSP-1083 administration.

Study Details

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

Key Dates

Start date
Dec 18, 2024
Status verified
Feb 2026
Primary completion
Dec 15, 2030
Completion
Dec 15, 2030

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Incidence and severity of Adverse Events. [ Time Frame: Up to 104 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Kentucky Medical CenterLexingtonKentucky40536
Lynne Cagle
[email protected]
859-218-5443
New York Presbyterian Hospital-Columbia University Medical CenterNew YorkNew York10032
Natasha Desai
[email protected]
347-882-4315

Find similar trials in Lexington, KY

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Kentucky Medical Center· Lexington, KYNew York Presbyterian Hospital-Columbia University Medical Center· New York, NY

Related Studies