RecruitingRecruiting
A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease
NCT07106021 · Kenai Therapeutics
In plain English
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Official title
A Phase 1b/2a Study Assessing the Safety and Efficacy of Intraputamenal Dopaminergic Stem Cell Transplants in Patients With Idiopathic Parkinson's Disease
About this study
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 criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Study design
Enrollment target: 12 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-17
Estimated completion: 2031-06
Last updated: 2026-01-23
Interventions
Biological: RNDP-001Device: Syringe Front-Loading Device
Primary outcomes
- • Safety and Tolerability (Baseline to 15 months post-transplant)
Sponsor
Kenai Therapeutics · industry
With: California Institute for Regenerative Medicine (CIRM)
Contacts & investigators
ContactGeneral Inquiries · contact · patients@kenaitx.com · <need to obtain>
All locations (3)
University of ArizonaRecruiting
Tucson, Arizona, United States
Keck Medical Center of University of Southern CaliforniaRecruiting
Los Angeles, California, United States
The Ohio State University Wexner Medical CenterRecruiting
Columbus, Ohio, United States