Nerve Tissue Implantation for Parkinson's Disease
(GUIDE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Peripheral Nerve Tissue Implantation for Parkinson's Disease?
Research shows that implanting peripheral nerve grafts in Parkinson's patients during deep brain stimulation surgery may improve motor function, as seen in a study where participants had better movement scores after 12 months. This suggests the treatment could have potential benefits, although more research is needed to confirm its effectiveness.12345
Is nerve tissue implantation safe for humans?
How does the nerve tissue implantation treatment for Parkinson's disease differ from other treatments?
This treatment involves implanting peripheral nerve tissue containing Schwann cells into the brain during deep brain stimulation surgery, aiming to restore nerve function by delivering neurotrophic factors. Unlike standard treatments, it focuses on potentially slowing disease progression by enhancing the brain's natural repair mechanisms.134910
What is the purpose of this trial?
This is an open-label, non-randomized, single-arm trial design to actively follow participants for 12 months. Ten participants will be enrolled to receive bilateral delivery of Peripheral Nerve Tissue (PNT) to the Substantia Nigra at the time of Deep Brain Stimulation (DBS) surgery. After 12 months, participants will be followed long term through annual visits for the rest of their lives. Participants will serve as their own donor for the tissue.
Research Team
Craig van Horne, MD, PhD
Principal Investigator
University of Kentucky
Eligibility Criteria
This trial is for people aged 40-75 with Parkinson's Disease who are able to undergo surgery and assessments, specifically those getting Deep Brain Stimulation (DBS) surgery. They must be willing to donate their own nerve tissue and not have had previous PD or brain surgeries. Pregnant women or those not using birth control are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Assessment
Participants are assessed preoperatively before undergoing DBS surgery and PNT delivery
Surgery and Treatment
Participants undergo DBS surgery and bilateral delivery of autologous PNT to the substantia nigra
Postoperative Monitoring
Participants are assessed postoperatively at two weeks after surgery for adverse events and clinical outcomes
Follow-up
Participants are monitored for safety and effectiveness at 6 months, 12 months, and annually thereafter
Long-term Follow-up
Participants are followed long term through annual visits for the rest of their lives
Treatment Details
Interventions
- Peripheral Nerve Tissue Implantation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Craig van Horne, MD, PhD
Lead Sponsor