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

Plain Language Summary

Simplified for easier understanding

This study is testing a new surgically implanted device called RNDP-001 to treat idiopathic Parkinson's disease (Parkinson's with no known genetic cause). Researchers want to find out if the implant is safe and whether it helps improve symptoms. **You may be eligible if:** - You have a confirmed diagnosis of idiopathic Parkinson's disease - You are between 45 and 75 years old - You are medically stable enough to undergo a surgical procedure **You may NOT be eligible if:** - You have a known Parkinson's disease gene mutation - You have previously had infusion therapy or surgery for Parkinson's disease - You have had an allergic reaction to an immunotherapy treatment - You cannot have an MRI scan - You have significant medical conditions that could interfere with surgery or the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRNDP-001

Stem cells

DEVICESyringe Front-Loading Device

Delivers the stem cells


Locations(3)

University of Arizona

Tucson, Arizona, United States

Keck Medical Center of University of Southern California

Los Angeles, California, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT07106021


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