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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 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 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05377281
The ClinicalTrials.gov registry entry for NCT05377281 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (98% lower). The listed sponsor is Craig van Horne, MD, PhD, which has 5 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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