Evidence map›Paper›PMID 40007169›Full record

ArticleJournal of Parkinson's disease2025

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

Jorge E Quintero, Monica J Chau, John T Slevin, Lisa Koehl, Julie A Gurwell, Elizabeth Wallace, Richard J Kryscio, Riham El Khouli, Amelia J Anderson-Mooney, Frederick A Schmitt and 2 more

3 registry-linked trialsAbstract read
In one paragraph

Article in Journal of Parkinson's disease, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02369003 phase1active not recruitingnot on this map

Continuation of a Pilot Study to Evaluate the Safety and Feasibility of Implanting Autologous Peripheral Nerve Grafts in Subjects With Parkinson's Disease Undergoing Deep Brain Stimulation Surgery and Treatment

TypeinterventionalSponsorCraig van Horne, MD, PhDRan2015 to 2027Enrolled70ConditionsParkinson's DiseaseArmsAutologous Peripheral Nerve Graft
NCT05377281 phase1active not recruitingnot on this map

Feasibility and Safety of autoloGous UncondItioneD pEripheral Nerve Tissue Delivery to the Substantia Nigra

TypeinterventionalSponsorCraig van Horne, MD, PhDRan2022 to 2027Enrolled10ConditionsParkinson's DiseaseArmsPeripheral Nerve Tissue Implantation
NCT06683378 phase1recruitingnot on this map

Phase I Randomized, Double-blind Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Nucleus Basalis of Meynert or Substantia Nigra for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery

TypeinterventionalSponsorCraig van Horne, MD, PhDRan2025 to 2028Enrolled24ConditionsParkinson's DiseaseArmsReparative Autologous peripheral nerve tissue
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Jorge E QuinteroNeurorestoration Center, University of Kentucky, Lexington, KY, USA.ORCID 0000-0003-3088-7565
Monica J ChauNeurorestoration Center, University of Kentucky, Lexington, KY, USA.ORCID 0000-0001-8858-9937
John T SlevinNeurorestoration Center, University of Kentucky, Lexington, KY, USA.ORCID 0000-0002-2403-4155
Lisa KoehlNeurorestoration Center, University of Kentucky, Lexington, KY, USA.
Julie A GurwellNeurorestoration Center, University of Kentucky, Lexington, KY, USA.
Elizabeth WallaceDepartment of Neurology, University of Kentucky, Lexington, KY, USA.ORCID 0000-0001-7680-1355
Richard J KryscioDepartment of Statistics, University of Kentucky, Lexington, KY, USA.
Riham El KhouliDepartment of Radiology, University of Kentucky, Lexington, KY, USA.ORCID 0000-0002-1892-491X
Amelia J Anderson-MooneyDepartment of Neurology, University of Kentucky, Lexington, KY, USA.ORCID 0000-0003-3876-0235
Frederick A SchmittNeurorestoration Center, University of Kentucky, Lexington, KY, USA.ORCID 0000-0003-4315-2488
Greg A GerhardtNeurorestoration Center, University of Kentucky, Lexington, KY, USA.
Craig G van HorneNeurorestoration Center, University of Kentucky, Lexington, KY, USA.ORCID 0000-0003-2989-5146

Funding

Kentucky Center for Clinical and Translational ScienceUL1TR001998 · NCATS · UNIVERSITY OF KENTUCKY · PI HARTMANN, KATHERINE E, KERN, PHILIP A · 2016 to 2025
$34.2M
NCATS NIH HHS UL1 TR001998
6 · The paper itself

Abstract

BackgroundMotor 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.ObjectiveReport on two-year compliance feasibility, safety, and clinical experience of combining this delivery at the time of deep brain stimulation (DBS) surgery.MethodsParticipants 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.ResultsSeventeen of 18 participants who underwent the procedure completed the 2-year study visits. No study-related serious adverse events occurred.ConclusionsThe 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.

Indexed as

Deep Brain StimulationParkinson DiseasePeripheral NervesSubstantia NigraAgedFeasibility StudiesFemaleFollow-Up StudiesHumansMaleMiddle AgedTransplantation, Autologouscell- and tissue-based therapydisease modifyingdisease progressionParkinson's disease

Identifiers

PMID40007169
PMCPMC13058830

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.