Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Multiple System Atrophy, Parkinsons Disease
In brief
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.
Key facts
- Study ID
- NCT06683365
- Run by
- Craig van Horne, MD, PhD
- People needed
- 7
- Starts
- 2025-02-25
- Expected to finish
- 2030-12-02
- Last updated by the study team
- 2026-04-01
Who can join
Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Previous PD surgery or intracranial surgery
- Ongoing major medical or psychiatric disorder incl. depression and psychosis
- Other concomitant treatment with neuroleptics
- Typical, nonparkinsonian syndrome ioflupane/SPECT signal
- Unable to undergo an MRI
- An obstructed trajectory path to the substantia nigra
- Significant microvascular disease
- 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
- 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.
Where it is running
- University of Kentucky — Lexington, Kentucky, United States (enrolling)
Full record on ClinicalTrials.gov
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