A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age45-75
SponsorKenai Therapeutics
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- RNDP-001
- Syringe Front-Loading Device
Treatment groups
12 Participants
are divided into 3 treatment groupsLocations
3University of Arizona85721, TucsonArizona, United States
Keck Medical Center of University of Southern California90033, Los AngelesCalifornia, United States
The Ohio State University Wexner Medical Center43210, ColumbusOhio, United States
Sponsors and collaborators
Kenai Therapeutics
Lead sponsor
California Institute for Regenerative Medicine (CIRM)
Collaborator
Source ClinicalTrials.gov