Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-75
SponsorCraig van Horne, MD, PhD
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sural Nerve Graft to the Substantia Nigra
- Sham surgery
Treatment groups
7 Participants
are divided into 2 treatment groupsSponsors and collaborators
Craig van Horne, MD, PhD
Lead sponsor
University of Kentucky
Sponsor institution
University of Kentucky CCTS
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Source ClinicalTrials.gov