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A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease

RECRUITINGPhase 1/2Sponsored by Kenai Therapeutics
Actively Recruiting
PhasePhase 1/2
SponsorKenai Therapeutics
Started2025-07-17
Est. completion2027-09
Eligibility
Age45 Years – 75 Years
Healthy vol.Accepted
Locations3 sites

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

Age: 45 Years – 75 YearsHealthy volunteers accepted
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

Conditions3

Idiopathic Parkinson´s DiseaseParkinson's DiseaseParkinson's Disease

Locations3 sites

Arizona

1 site
University of Arizona
Tucson, Arizona, 85721
Marisa Valletta1 (520) 626-7322COM-Neurosurgtrials@arizona.edu

California

1 site
Keck Medical Center of University of Southern California
Los Angeles, California, 90033

Ohio

1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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