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Abstract

Background: Motor dysfunction in Parkinson's disease (PD) is characterized by a loss of functioning neurons in the substantia nigra. Two options exist when encountering damaged neurons: replace or support. We implemented a strategy of using autologous peripheral nerve tissue, in a reparative state, to provide a collection of neurorestorative support to unhealthy neurons with the goal of modifying the motor progression of PD. Objective: Report on two-year compliance feasibility, safety, and clinical experience of combining this delivery at the time of deep brain stimulation (DBS) surgery. Methods: Participants with PD undergoing open-label peripheral nerve tissue implantation to the substantia nigra at the time of DBS surgery were followed from pre-surgery to two years after surgery through clinical evaluations. Results: Seventeen of 18 participants who underwent the procedure completed the 2-year study visits. No study-related serious adverse events occurred. Conclusions: The trial met its primary endpoints of feasibility and safety. We were able to practicably and safely implant participants and have participants comply with 2-year visits and exams. Adverse events related to study participation were deemed manageable by participants.

Document Type

Article

Publication Date

3-1-2025

Notes/Citation Information

Publisher Copyright: © The Author(s) 2025. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).

Digital Object Identifier (DOI)

10.1177/1877718X241312409

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