Actively Recruiting
Led by Craig van Horne, MD, PhD · Updated on 2026-04-01
7
Participants Needed
1
Research Sites
104 weeks
Total Duration
C
Craig van Horne, MD, PhD
Lead Sponsor
U
University of Kentucky CCTS
Collaborating Sponsor
Researchers are evaluating the safety and feasibility of implanting a person's own peripheral nerve tissue into the substantia nigra area of the brain in people diagnosed with Parkinson's disease or Multiple System Atrophy. This phase I study involves 7 participants who are early in their diagnosis with milder symptoms. The goal is to plan future larger trials and to see if this nerve tissue grafting approach is possible and safe. Participants will be randomly assigned to one of two groups: four will receive the nerve tissue graft implanted into the brain, while three will receive a sham surgery involving nerve biopsy and scalp incisions but no brain implantation. The nerve tissue is taken from the sural nerve near the ankle and implanted bilaterally using a specialized cannula through the skull. Those in the sham group may be eligible for the graft surgery after the study ends. During the study, participants will be followed for one year with regular assessments including neuropsychological exams, movement disorder scales, cognitive tests, quality of life questionnaires, and monitoring for adverse events. Researchers will track surgery details such as procedure duration and hospital stay. The primary goal is to meet recruitment targets and evaluate safety and feasibility through various clinical and functional measures over the 12-month period.
CONDITIONS
Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus hospital admission until discharge
Participants undergo surgery where either their own sural nerve cells are implanted into the substantia nigra area of the brain or receive a sham surgery with sural nerve biopsy and scalp incisions only.
1 surgical procedure with hospital admission
Duration - 12 months
Participants have follow-up visits to monitor safety and assess clinical outcomes after the surgery.
Multiple visits including assessments at 4 weeks, 6 months, and 12 months
Total: 1 location
1
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
J
Jaimie Hixson
G
Group Monitored Email
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Jorge E Quintero, John T Slevin, Julie A Gurwell...
https://pubmed.ncbi.nlm.nih.gov/35949912Craig G van Horne, Jorge E Quintero, Julie A Gurwell...
https://pubmed.ncbi.nlm.nih.gov/27153166Craig G van Horne, Jorge E Quintero, John T Slevin...
https://pubmed.ncbi.nlm.nih.gov/29451447