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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 40 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • Any condition that would not make the subject a candidate for DBS - Previous PD surgery or intracranial surgery - Typical, nonparkinsonian syndrome ioflupane/SPECT signal - 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Implantation of peripheral nerve tissue 		Bilateral deployment of peripheral nerve tissue to the substantia nigra.
  • Procedure: Peripheral Nerve Tissue Implantation
    At the time participants are receiving the standard of care deep brain stimulation (DBS) surgery, a standard incision on the lateral aspect near the ankle is made, the sural nerve is identified, an about 3 cm biopsy of the sural nerve is obtained and the incision is closed. From the biopsied section, the epinerium is removed, fascicles are cut, and (~5 pieces per side; ~ 5mm length x 1.5 mm diameter: approximately 10 cubic millimeters) implanted bilaterally into the substantia nigra.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Morgan Yazell, MBA
859-218-5060
morgan.yazell@uky.edu

More Details

NCT ID
NCT05377281
Status
Recruiting
Sponsor
Craig van Horne, MD, PhD

Study Contact

Morgan Yazell, MBA
859-218-5060
morgan.yazell@uky.edu

Detailed Description

We recently designed open-label safety studies to investigate the use of an autologous source of cellular tissue from the peripheral nervous system (van Horne et al., 2017, 2018; Quintero et al. 2022), reparative peripheral (sural) nerve tissue containing a variety of cells and neuroprotective factors (Chau et al. 2022). While our previous studies have used injury-activated peripheral nerve tissue (PNT), where the sural nerve is transected and allowed to regenerate in situ for up to about 2 weeks before implantation, here we propose to use naïve, previously uninjured, nerve tissue delivered bilaterally to the substantia nigra at the time participants are undergoing deep brain stimulation (DBS) surgery. Participants will be assessed preoperatively, then undergo DBS surgery and delivery of autologous PNT, and then assessed postoperatively at two weeks after surgery, 6 months, 12 months and annually thereafter for adverse events and clinical outcomes.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.