Syringe Front-Loading Device: Delivers the stem cells
Study 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
Sex
ALL
Min age
45 Years
Max age
75 Years
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
Primary outcome measure(s)
Safety and Tolerability — Baseline to 15 months post-transplant The incidence of adverse events (AEs), serious AEs, AEs of special interest, and patient withdrawals
Trial sites (3)
Facility
City
Region
Status
University of Arizona
Tucson
Arizona
Keck Medical Center of University of Southern California
Los Angeles
California
The Ohio State University Wexner Medical Center
Columbus
Ohio
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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