NCT06683365 Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies
| NCT ID | NCT06683365 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Craig van Horne, MD, PhD |
| Condition | Multiple System Atrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 7 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2028-12-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 7 participants in total. It began in 2025-02-25 with a primary completion date of 2028-12-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Craig van Horne, MD, PhD
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT06683365 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Multiple System Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06683365 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06683365 currently recruiting?
Yes, NCT06683365 is actively recruiting participants. Contact the research team at jaimie.henderson@uky.edu for enrollment information.
Where is the NCT06683365 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT06683365 clinical trial?
NCT06683365 is sponsored by Craig van Horne, MD, PhD. The principal investigator is Craig van Horne, MD, PhD at University of Kentucky. The trial plans to enroll 7 participants.