NCT06683365RecruitingPhase 1
Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies
A Phase I Study of the Feasibility and Safety of SuraL nervE Tissue Grafting to the Substantia nigrA in Patients With Synucleinopathies (LEAP)
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (estimated)
- First submitted
- 7 Nov 2024
- Start date
- 25 Feb 2025
- Primary completion date
- 2 Dec 2028
- Lead sponsor
- Craig van Horne, MD, PhD
- Diseases
- Parkinson disease
- NCT number
- NCT06683365
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 7
- From 25 Feb 2025 to the primary completion date, 2 Dec 2028
- 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 concomitant treatment with neuroleptics
- Consent capacity will be assessed and determined during and throughout a participant's neuropsychological exam. A participant who experiences a decline in consent capacity prior to surgery, will be removed from the study by the PI. A decline in consent capacity after surgery will not result in the removal of the participant in the study.
Other illness
- Ongoing major medical or psychiatric disorder incl. depression and psychosis
- Typical, nonparkinsonian syndrome ioflupane/SPECT signal
- Significant microvascular disease
Other
- Unable to undergo an MRI
- An obstructed trajectory path to the substantia nigra
- Use of anticoagulants other than aspirin
- Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study
Who the study is looking for
- Diagnosis of clinically established or clinically probable PD or MSA as defined by MDS criteria
- Disease duration greater than 2 years
- Age 40-75, inclusive
- MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III greater than or equal to 20 points but less than or equal to 35 points, off anti-parkinsonian medication for PD or MDS-Unified Multiple System Atrophy Rating Scale (UMSARS) less than or equal to 30 points off anti-parkinsonian medication
- No MDS-UPDRS Part III score \>3 on items 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.14 while off medication
- 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. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.