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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Stem cells
Delivers the stem cells
University of Arizona
Tucson, Arizona, United States
RECRUITINGKeck Medical Center of University of Southern California
Los Angeles, California, United States
RECRUITINGThe Ohio State University Wexner Medical Center
Columbus, Ohio, United States
RECRUITINGSafety and Tolerability
The incidence of adverse events (AEs), serious AEs, AEs of special interest, and patient withdrawals
Time frame: Baseline to 15 months post-transplant
Changes from Baseline in Quality ON time measured by PD diary
Time frame: Baseline to 15 months post-transplant
Changes in Dopaminergic Function and Activity in the Brain
Changes in L-DOPA-positron emission tomography (PET)
Time frame: Baseline to 15 months post-transplant
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