Autologous Peripheral Nerve Grafts Into the Substantia Nigra of Subjects With PD Undergoing Deep Brain Stimulation

Completed · Not applicable

Conditions studied: Parkinson's Disease

In brief

By doing this study, the investigators hope to learn provide safety data that can be used to generate a larger phase III clinical trial. If successful, it would promote the development of a new treatment for PD in which patients are able to provide their own tissue as a source of a supportive environment for the injured and dying cells and thereby possibly stopping the progression of the illness or even improve the symptoms of PD. The purpose of this research is to gather information on the safety and feasibility of nerve graft implantation is. The results of this study will be shared with the University of Kentucky, Center for Clinical and Translational Science (group providing financial support for the study) and other federal agencies, if required. The overall goal of this research is to develop a novel, regenerative treatment strategy for idiopathic Parkinson's disease (PD) that is safe, cost effective and widely available to patients.

Key facts

Study ID

NCT01833364

Run by

Craig van Horne, MD, PhD

People needed

8

Starts

2013-04-01

Expected to finish

2015-09-01

Last updated by the study team

2016-03-09

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Elected to have DBS Surgery
• Parkinson's Disease for 5 years or more
• Ages 40-75

You may not qualify if…

• Have previously undergone PD surgery or any intracranial surgery
• Unwilling to delay taking PD medications during the study
• Unable to follow the directions of the study team
• Unable to attend all study visits
• Have participated in previous clinical studies and received an investigational product within 30 days of screening

Where it is running

• University of Kentucky Medical Center — Lexington, Kentucky, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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