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NCT05377281 · ClinicalTrials.gov registry record · Phase 1
Feasibility and Safety of autoloGous UncondItioneD pEripheral Nerve Tissue Delivery to the Substantia Nigra (GUIDE)
A Phase 1 study of Parkinson's Disease, sponsored by Craig van Horne, MD, PhD.
- Active
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05377281: Active Phase 1 study of Parkinson's Disease, sponsored by Craig van Horne, MD, PhD.
NCT05377281 is a Phase 1 study of Parkinson's Disease that is active but no longer recruiting, run by Craig van Horne, MD, PhD. The registered enrollment target is 10 participants, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05377281, a Phase 1 study of Parkinson's Disease, is active but no longer recruiting, sponsored by Craig van Horne, MD, PhD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Successful bilateral graft delivery to the substantia nigra at a proportion = 70%.
Conditions Studied
Interventions
- PROCEDURE Peripheral Nerve Tissue Implantation
Study Locations (1)
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-07-07 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 1 |
What the registry record for NCT05377281 still lists
NCT05377281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 1 intervention - of which Peripheral Nerve Tissue Implantation is the first listed.
NCT05377281 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT05377281 about?
NCT05377281 is a clinical study titled "Feasibility and Safety of autoloGous UncondItioneD pEripheral Nerve Tissue Delivery to the Substantia Nigra (GUIDE)". 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,...
What is the current status of trial NCT05377281?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2022-07-07. Estimated completion is 2027-06-30.
What conditions does trial NCT05377281 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT05377281?
The interventions under investigation include: Peripheral Nerve Tissue Implantation (PROCEDURE).
Who is sponsoring clinical trial NCT05377281?
This trial is sponsored by Craig van Horne, MD, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05377281 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Parkinson's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05377281's enrollment target sits among peer trials
10 146th of 158 higher than 8 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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