Nerve Tissue Implantation for Parkinson's Disease

(GUIDE Trial)

Overseen By Morgan Yazell, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Craig van Horne, MD, PhD

Disqualifiers: Previous PD surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether implanting peripheral nerve tissue can improve symptoms in people with Parkinson's disease. The treatment involves placing this tissue in a specific brain area during Deep Brain Stimulation surgery. Suitable candidates for this trial are those already scheduled for this surgery and have a confirmed Parkinson's disease diagnosis. The goal is to determine if this new approach can enhance condition management. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

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 prior data suggests that this nerve tissue implantation is safe for Parkinson's Disease?

Research has shown that implanting Peripheral Nerve Tissue (PNT) is generally safe for people with Parkinson's disease. One study demonstrated that participants could safely receive this treatment during Deep Brain Stimulation (DBS) surgery. However, some patients experienced mild side effects, such as numbness or tingling in the foot and ankle where the nerve was taken. These findings suggest the treatment is well-tolerated, but awareness of potential minor side effects is important. Overall, the treatment has shown promise in similar situations. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's Disease?

Unlike the standard treatments for Parkinson's disease, which often include medications like levodopa that aim to manage symptoms by increasing dopamine levels, the peripheral nerve tissue implantation offers a novel approach. This experimental treatment targets the substantia nigra, a critical area in the brain affected by Parkinson's. By implanting peripheral nerve tissue directly into this region, the treatment aims to restore nerve function and potentially slow disease progression. Researchers are excited about this innovative method because it goes beyond merely managing symptoms and seeks to address the underlying neural degeneration in Parkinson's disease.

What evidence suggests that Peripheral Nerve Tissue Implantation might be an effective treatment for Parkinson's Disease?

Research suggests that adding a small piece of nerve tissue during specific surgery for Parkinson's patients might improve their movement. This trial involves implanting peripheral nerve tissue, which releases substances that support and protect brain cells, potentially slowing or stopping the disease's progression. In earlier studies, patients who received this treatment showed signs of improvement. Although more research is needed, these early results offer hope for people with Parkinson's. ^{1 2 3 4 6}

Who Is on the Research Team?

Craig van Horne, MD, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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

I am fit for surgery.

I am willing and able to undergo a specific brain scan.

I am between 40 and 75 years old.

Exclusion Criteria

I am not pregnant, breastfeeding, and if able to bear children, I agree to use birth control during the study.

Presence of typical, nonparkinsonian syndrome ioflupane/SPECT signal

My brain pathway to the substantia nigra is blocked.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants are assessed preoperatively before undergoing DBS surgery and PNT delivery

1-2 weeks

Surgery and Treatment

Participants undergo DBS surgery and bilateral delivery of autologous PNT to the substantia nigra

At the time of surgery

1 visit (in-person)

Postoperative Monitoring

Participants are assessed postoperatively at two weeks after surgery for adverse events and clinical outcomes

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness at 6 months, 12 months, and annually thereafter

12 months

3 visits (in-person)

Long-term Follow-up

Participants are followed long term through annual visits for the rest of their lives

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Peripheral Nerve Tissue Implantation

Trial Overview The study tests the safety of implanting a patient's own Peripheral Nerve Tissue into their brain region called Substantia Nigra during DBS surgery. It's an open-label trial where participants will be monitored for one year post-surgery, then annually for life.

How Is the Trial Designed?

Group I: Implantation of peripheral nerve tissue Experimental Treatment 1 Intervention

Bilateral deployment of peripheral nerve tissue to the substantia nigra.

Who Is Running the Clinical Trial?

Craig van Horne, MD, PhD

Lead Sponsor

Trials

5

Recruited

120+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40007169/

Two-year feasibility and safety of open-label autologous ... We also did preliminary testing of whether the support provided by the nerve implant could slow or stop the disease from getting worse over ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02369003

NCT02369003 | Cont. of a Study to Evaluate Implanting ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9295654/

Direct delivery of an investigational cell therapy in patients ... All participants were successfully implanted with a DBS system and subsequently received therapeutic programming and treatment. With respect to the PNT ...

4. withpower.com withpower.com/trial/phase-1-parkinson-disease-4-2022-b4e78

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 ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/1877718X241312409

Two-year feasibility and safety of open-label autologous ... Two-year feasibility and safety of open-label autologous peripheral nerve tissue implantation during deep brain stimulation in patients with Parkinson's disease.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06683378

NCT06683378 | A Study to Evaluate Feasibility, Safety, and ... Two-year feasibility and safety of open-label autologous peripheral nerve tissue implantation during deep brain stimulation in patients with Parkinson's disease ...