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Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies

Study acronym: LEAP
StatusRecruiting
PhasePhase 1
Started2025-02-25
View on ClinicalTrials.gov ↗
This phase I double-blind study focuses on the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the substantia nigra area of the brain in persons who have been diagnosed with either Parkinson's disease (PD) or Multiple System Atrophy (MSA). 7 participants will be enrolled, with 4 participants receiving the graft and 3 receiving a sham surgery. Eligible participants will be early in their diagnosis with a lower burden of symptoms. Participants will be followed initially for one year after surgery.

Amendment record

Amended 3 times since 2024-11-08; most recent filed 2026-03-26. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-03-26
Amendment Study Status, Sponsor/Collaborators, Contacts/Locations v3
2025-03-24
Amendment Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations, References v2
2025-01-14
Amendment Study Status, Eligibility v1
2024-11-08
Original filing
Trial Details
NCT Number NCT06683365
Lead Sponsor Craig van Horne, MD, PhD
Collaborators: University of Kentucky CCTS, National Center for Advancing Translational Sciences (NCATS)
Conditions Multiple System Atrophy, Parkinsons Disease
Enrollment 7 participants
Start Date 2025-02-25
Primary Completion 2028-12-02 (estimated)
Study Completion 2030-12-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-31