Two-year feasibility and safety of open-label autologous peripheral nerve tissue implantation during deep brain stimulation in patients with Parkinson's disease.

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.