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FEASIBILITY AND SAFETY OF SIMULTANEOUSLY IMPLANTING AUTOLOGOUS REGENERATIVE PERIPHERAL NERVE TISSUE TO THE NUCLEUS BASALIS OF MEYNERT AND SUBSTANTIA NIGRA IN PATIENTS WITH PARKINSON’S DISEASE
Abstract
Aims
Assess the feasibility and safety of concurrently delivering an investigational cell therapy, containing cell-growth and -survival factors, to the substantia nigra (SN) and nucleus basalis of Meynert (NBM) in patients with Parkinson’s disease (PD) at the time of deep brain stimulation (DBS) surgery.
Methods
Two participants with idiopathic PD demonstrating mild cognitive impairment underwent unilateral, stereotactic implantation of autologous regenerative peripheral nerve tissue (PNT) to the SN and NBM contralateral to the most affected side at the time they received bilateral DBS electrodes.
Results
Both participants (65M, 66F) successfully received unilateral PNT delivery to the SN and NBM areas. No serious adverse events related to the direct delivery of PNT were observed. However, one participant had worsening anxiety that prevented her from completing 12 month neurocognitive and PD severity scale assessments. Long-term follow up, 6 or 12 months post-implantation, showed stable performance on PD testing. Neurocognitive assessment for the one participant at 18 months post-surgery showed changes in phonemic fluency (z-score: -1.4), visuomotor construction and praxis (WAIS-IV Block Design: -1.0), mental flexibility and switching (TMT-B: -1.8), novel problem solving (WCST-64 Total Errors: +1.6), rote verbal learning (HVLT-R Total: +1.3), and delayed verbal recall (HVLT-R Delayed Recall: +1.5).
Conclusions
We report the successful direct delivery of an investigational cell therapy, as autologous PNT, to two separate targets at the time participants underwent DBS surgery. We plan to continue exploring the potential for this approach to modify the progression of damaged networks in neurodegenerative disorders.