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
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|
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)|
|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|
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.
- 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).
- 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.
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
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Craig van Horne, MD, PhD||University of Kentucky|