A Phase 1b/2a Study Assessing the Safety and Efficacy of Intraputamenal Dopaminergic Stem Cell Transplants in Patients With Idiopathic Parkinson's Disease
Kenai Therapeutics
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 range
- 45–75 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- BiologicalRNDP-001
Stem cells
- DeviceSyringe Front-Loading Device
Delivers the stem cells
Locations (3)
- University of ArizonaTucson, Arizona
- Keck Medical Center of University of Southern CaliforniaLos Angeles, California
- The Ohio State University Wexner Medical CenterColumbus, Ohio