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RECRUITING
NCT06683365
PHASE1

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

Sponsor: Craig van Horne, MD, PhD

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase I Study of the Feasibility and Safety of SuraL nervE Tissue Grafting to the Substantia nigrA in Patients With Synucleinopathies (LEAP)

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

7

Start Date

2025-02-25

Completion Date

2030-12-02

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

PROCEDURE

Sural Nerve Graft to the Substantia Nigra

Participants assigned to this arm will have the sural nerve biopsied from one of their ankles. This cellular tissue will be deposited bilaterally into the substantia nigra area of their brain by a specialized cannula via bilateral scalp incisions and skull burr holes.

PROCEDURE

Sham surgery

Participants assigned to this arm will have the sural nerve from one of their ankles biopsied in the same fashion as the experimental arm. Bilateral incisions will be made on the participants scalp but no burr holes into the skull and no cannula passes into the brain will occur.

Locations (1)

University of Kentucky

Lexington, Kentucky, United States