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Feasibility and Safety of autoloGous UncondItioneD pEripheral Nerve Tissue Delivery to the Substantia Nigra (GUIDE)

Name: Feasibility and Safety of autoloGous UncondItioneD pEripheral Nerve Tissue Delivery to the Substantia Nigra (GUIDE) — clinical trial record (NCT05377281)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: GUIDE

StatusActive, Not Recruiting

PhasePhase 1

SponsorCraig van Horne, MD, PhD

Started2022-07-07

View on ClinicalTrials.gov ↗

This is an open-label, non-randomized, single-arm trial design to actively follow participants for 12 months. Ten participants will be enrolled to receive bilateral delivery of Peripheral Nerve Tissue (PNT) to the Substantia Nigra at the time of Deep Brain Stimulation (DBS) surgery. After 12 months, participants will be followed long term through annual visits for the rest of their lives. Participants will serve as their own donor for the tissue.

Amendment history 1 change detected by DataLookout

2026-09-01

Primary completion moved earlier: 2027-06-30 → 2026-12-30

Trial Details

NCT Number	NCT05377281
Lead Sponsor	Craig van Horne, MD, PhD
Conditions	Parkinson's Disease
Enrollment	10 participants
Start Date	2022-07-07
Primary Completion	2026-12-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-31