NCT05377281Active, not recruitingPhase 1
Feasibility and Safety of autoloGous UncondItioneD pEripheral Nerve Tissue Delivery to the Substantia Nigra (GUIDE)
Feasibility and Safety of autoloGous UncondItioneD pEripheral Nerve Tissue Delivery to the Substantia Nigra
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 4 May 2022
- Start date
- 7 Jul 2022
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Craig van Horne, MD, PhD
- Diseases
- Parkinson disease
- NCT number
- NCT05377281
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 7 Jul 2022 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous PD surgery or intracranial surgery
Other illness
- Any condition that would not make the subject a candidate for DBS
- Typical, nonparkinsonian syndrome ioflupane/SPECT signal
Other
- Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study
- Unable to undergo an MRI
- An obstructed trajectory path to the substantia nigra
Who the study is looking for
- Undergoing DBS
- Diagnosis of clinically established or clinically probably PD (Parkinson's disease) as defined by MDS criteria
- Age 40-75, inclusive
- Able and willing to undergo ioflupane/SPECT
- Able to tolerate the surgical procedure
- Able to undergo all planned assessments
- Available access to the sural nerve
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.