RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
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
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
BIOLOGICAL
RNDP-001
Stem cells
DEVICE
Syringe 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