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Cont. of a Study to Evaluate Implanting Peripheral Nerve Grafts Into Subjects With Parkinson's Disease (PD) During DBS (APNG2)

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ClinicalTrials.gov Identifier: NCT02369003
Recruitment Status : Enrolling by invitation
First Posted : February 23, 2015
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Craig van Horne, MD, PhD, University of Kentucky

Brief Summary:

This pilot study is designed to follow up on a previous, preliminary study and test the long-term safety and feasibility of the implantation of autologous peripheral nerve grafts into the substantia nigra, basal forebrain, putamen, and/or STN of participants with PD undergoing deep brain stimulation (DBS) surgery. Peripheral nerve tissue contains Schwann cells which produce growth factors that have been demonstrated to support the survival and function of neurons.

Participants will serve as their own donor for the tissue, which will be implanted at the time they undergo DBS surgery.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Procedure: Autologous Peripheral Nerve Graft Phase 1

Detailed Description:

The primary objective of this pilot study is to demonstrate safety of the approach: introducing a minor modification of a standard, FDA approved neurosurgical procedure in use for over a decade to implant autologous peripheral nerve into the central nervous system. As such, the study is designed to pose minimal risk and minimal inconvenience to the subjects. Additionally, the test paradigm is performed strategically to not interfere with the surgery or delivery of the scheduled clinical DBS therapy. The scientific basis for this study is that the implanted peripheral nerve tissue is naturally well suited to provide multiple growth factors that have been shown experimentally to support the survival and function of dopaminergic neurons. Central to this proposal is the hypothesis that the implanted tissue will physiologically deliver growth factors to restore to normal function the afflicted neurons found in PD.

The first specific aim is to assess the feasibility and safety of the combined peripheral nerve graft/DBS surgical procedure. The second specific aim is to evaluate the long term clinical safety of the peripheral nerve implant.

This pilot study will provide safety data that can be used to generate a larger phase III clinical trial. If successful, it would herald the development of a new treatment for PD in which patients are able to provide their own tissue as a source of growth factors that could arrest or reverse the ongoing cellular loss that is responsible for their devastating dysfunction.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Peripheral Nerve Graft
The intervention includes the surgical implantation of autologous peripheral nerve graft into the substantia nigra, basal forebrain, putamen, and/or STN of participants with Parkinson's Disease that are undergoing Deep Brain Stimulation (DBS).
Procedure: Autologous Peripheral Nerve Graft
Implantation of Autologous Peripheral Nerve Graft into the substantia nigra, basal forebrain, putamen, and/or STN of participants with PD undergoing deep brain stimulation (DBS) surgery.




Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 Months ]
    Safety and Tolerability of Nerve Graft Implantation. All adverse events will be collected from the time participant signs the consent to the time they complete study visit at 24 months in order to measure the safety and tolerability of the grafting procedure. Adverse events will be documented and compared to the known and reported adverse events of DBS of Subthalamic Nucleus (STN) or internal globus pallidus (GPi).


Secondary Outcome Measures :
  1. DaTscan assessment [ Time Frame: 24 months ]
    Dopamine neurodegeneration at 24 months will be assessed using DaTscan SPECT imaging and compared to scans obtained before DBS surgery.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing DBS of the STN or GPi
  • Between the ages of 40-75
  • Able to give informed consent
  • Show a positive response to Sinemet (carbidopa/levodopa)
  • Be able to tolerate the surgical procedure

Exclusion Criteria:

  • Any condition that would not make the subject a candidate for DBS of the STN or GPi
  • Under the age of 40 or over the age of 75
  • Unable to give informed consent
  • Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369003


Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Craig van Horne, MD, PhD
Investigators
Principal Investigator: Craig van Horne, MD, PhD University of Kentucky

Publications:
Responsible Party: Craig van Horne, MD, PhD, Principal Investigtator, University of Kentucky
ClinicalTrials.gov Identifier: NCT02369003     History of Changes
Other Study ID Numbers: 14-0729-F6A
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018

Keywords provided by Craig van Horne, MD, PhD, University of Kentucky:
Deep Brain Stimulation
Schwann Cells

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases