A Pilot Study to Evaluate the Safety and Feasibility of Implanting Autologous Peripheral Nerve Grafts Into the Substantia Nigra of Subjects With Parkinson's Disease Undergoing Deep Brain Stimulation Surgery and Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Safety and Tolerability of Nerve Graft Implantation
研究概览
简要总结
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.
详细描述
This pilot study is designed to test the safety and feasibility of the implantation of the subject's own peripheral nerve tissue into an area of the brain called the substantia nigra. Only subjects who have elected to undergo DBS surgery will be asked to participate in this research study.
The implantation of the nerve graft will take place in the operating room at the end of the second stage surgery for DBS. Subjects will be asked to donate a piece of their own peripheral nerve tissue that will be used to create the graft for their implantation. The peripheral nerve tissue is obtained from a small incision (approximately 2 inches) above and on the outer-side of one ankle. The initial incision is created during stage I of the DBS procedure and will take place under general anesthesia. The incision will be closed with internal sutures, and a dressing will cover the incision after the procedure.
The nerve will be harvested during stage II of the DBS procedure. This involves opening the same incision using local anesthesia injected around the incision site. Once a small piece (about an inch) of the nerve is removed, the incision will be sutured closed with internal stitches. These stitches will dissolve on their own and will not need to be removed in the office.
Follow-up. Subjects will be followed in our clinic for for DBS follow-up visits and treatment, none of those visits are part of this study.
Prior to coming in for study visits subjects will need to stop taking their PD medications 12 hours before each visit. Subjects will be allowed to restart their normal PD medication during the examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elected to have DBS Surgery
- •Parkinson's Disease for 5 years or more
- •Ages 40-75
排除标准
- •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
结局指标
主要结局
Safety and Tolerability of Nerve Graft Implantation
时间窗: One year
All Adverse events will be collected from the time subject signs the consent to the time they complete study visit 12 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 STN. In addition, MRI imaging of the graft site within the substantia nigra will be compared to the contralateral, non-grafted site.
次要结局
- Peripheral Nerve Graft Efficacy -- clinical improvement(1 year)
- Peripheral Nerve Graft Efficacy -- Therapy Reduction(1 year)
- Peripheral Nerve Graft Efficacy -- Quality of Life(1 year)
研究者
Craig van Horne, MD, PhD
Principal Investigator
University of Kentucky