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NCT07106021 | RECRUITING | Idiopathic Parkinson´s Disease

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

Kenai Therapeutics

Brief 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.

Condition or disease

Idiopathic Parkinson´s Disease

Parkinson's Disease

Intervention/treatment

RNDP-001

Syringe Front-Loading Device

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 12 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-07-17
Estimated Primary Completion Date : 2027-09
Estimated Study Completion Date : 2031-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease

Location Details

NCT07106021

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

University of Arizona

Tucson, arizona, United States, 85721

RECRUITING

United States, California

Keck Medical Center of University of Southern California

Los Angeles, California, United States, 90033

RECRUITING

United States, Ohio

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210