RecruitingPhase 1Phase 2NCT07106021
A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease
A Phase 1b/2a Study Assessing the Safety and Efficacy of Intraputamenal Dopaminergic Stem Cell Transplants in Patients With Idiopathic Parkinson's Disease
Sponsor
Kenai Therapeutics
Enrollment
12 participants
Start Date
Jul 17, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This clinical trial is designed to test the safety and tolerability of the study intervention, RNDP-001, which will be implanted into the brain of study participants during a surgical procedure.
Eligibility
Min Age: 45 YearsMax Age: 75 Years
Inclusion Criteria3
- Diagnosis of idiopathic Parkinson's disease consistent with the Movement Disorders Society Clinical Criteria
- Age 45 to 75
- Medically stable to undergo a surgical procedure
Exclusion Criteria5
- Known Parkinson's disease gene mutation or variant
- Previous infusion therapy or surgery for Parkinson's disease
- History of allergic reaction or intolerance to an immunotherapeutic agent
- Contraindication to MRI
- Clinically significant medical conditions likely to interfere with the surgical procedure or study assessments
Interventions
BIOLOGICALRNDP-001
Stem cells
DEVICESyringe Front-Loading Device
Delivers the stem cells
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07106021
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