Peripheral Nerve Tissue Implantation for Parkinson's Disease

(STAR Trial)

Overseen By Group Monitored Email

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Craig van Horne, MD, PhD

Disqualifiers: Dementia, Previous PD surgery, others

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

Compensation: Varies

Number of Visits: 6

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for Parkinson's Disease to determine if implanting reparative autologous peripheral nerve tissue can repair brain areas affected by the disease. Researchers aim to see if this approach can enhance thinking, movement, and daily life for people with Parkinson's. Participants will receive a nerve tissue implant during their standard deep brain stimulation surgery. This trial is suitable for those diagnosed with Parkinson's who are already planning to undergo deep brain stimulation and can handle the surgery. 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 therapy.

Do I need to stop my current medications for the trial?

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 peripheral nerve tissue implantation is safe for Parkinson's Disease patients?

Research shows that using peripheral nerve tissue (PNT) in treating Parkinson's disease appears promising for safety. Previous studies have found that placing this tissue into the brain, particularly in areas like the substantia nigra (SN) or the nucleus basalis of Meynert (NBM), is generally well-tolerated.

For the substantia nigra, studies over two years with participants who had deep brain stimulation (DBS) demonstrated that the procedure is feasible and safe. The tissue was implanted successfully without major issues.

Similarly, studies on the nucleus basalis of Meynert also highlighted safety. Participants did not encounter major safety problems, and the procedure was generally well-accepted.

Overall, earlier research considers PNT implantation safe. However, as these studies are still in the early stages, ongoing trials will continue to monitor and confirm this safety profile. ^{1 2 3 4 5}

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

Researchers are excited about the use of reparative autologous peripheral nerve tissue for Parkinson's disease because it offers a novel approach by directly implanting nerve tissue into specific brain areas affected by the disease. Unlike traditional treatments like levodopa or dopamine agonists, which work to manage symptoms by altering neurotransmitter levels, this innovative method aims to repair or replace damaged neural pathways. The treatment is unique in its potential to restore function in the Substantia Nigra and the nucleus basalis of Meynert, regions crucial for movement and cognitive processing. By targeting the root cause of neural degeneration, this approach holds promise for more sustainable and transformative outcomes for patients.

What evidence suggests that this trial's treatments could be effective for Parkinson's Disease?

Research has shown that using a person's own nerve tissue to treat Parkinson's disease holds promise for improving movement and cognitive issues. In this trial, participants will receive peripheral nerve tissue (PNT) deployment to either the substantia nigra or the nucleus basalis of Meynert. Studies have demonstrated that placing this nerve tissue in the substantia nigra is feasible and does not cause serious side effects. This method may help repair damaged brain areas. Similarly, placing the nerve tissue in the nucleus basalis of Meynert has proven safe and might enhance cognitive skills. The nerve tissue is thought to support brain health and function. Although early results are encouraging, further research is necessary to confirm these benefits. ^{1 2 3 4 5}

Who Is on the Research Team?

Craig G van Horne, MD, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's Disease who are already planning to get deep brain stimulation (DBS) surgery. They should be diagnosed with idiopathic Parkinson's and willing to have additional experimental treatment involving their own nerve tissue implanted in the brain.

Inclusion Criteria

I am fit for surgery.

Undergoing DBS

Able to undergo all planned assessments

Exclusion Criteria

Any condition that would not make the subject a candidate for DBS

I have been diagnosed with dementia.

Unable to undergo an MRI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo DBS surgery and receive bilateral PNT deployment to either the NBM or SN

Intraoperative

1 visit (in-person)

Post-surgery Evaluation

Participants are evaluated for neurocognitive, motoric function, activities of daily living, and quality of life

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

4 visits (in-person) at 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Reparative Autologous peripheral nerve tissue

Trial Overview The study tests implanting a patient's own peripheral nerve tissue into two different brain areas during DBS surgery. It aims to see if this can help non-motor or motor symptoms of Parkinson’s. Participants will be randomly assigned to receive the tissue in either the NBM or SN area.

How Is the Trial Designed?

Group I: Peripheral nerve tissue (PNT) deployment to the Substantia Nigra Active Control 1 Intervention

Group II: Peripheral nerve tissue (PNT) deployment to the nucleus basalis of Meynert Active Control 1 Intervention

Who Is Running the Clinical Trial?

Craig van Horne, MD, PhD

Lead Sponsor

Trials

5

Recruited

120+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

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

Two-year feasibility and safety of open-label autologous ... We implemented a strategy of using autologous peripheral nerve tissue, in a reparative state, to provide a collection of neurorestorative support to unhealthy ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06683378

NCT06683378 | A Study to Evaluate Feasibility, Safety, and ... A Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Brain for Non-motor or Motor Symptoms ...

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

Direct delivery of an investigational cell therapy in patients ... What this study adds. The procedure of deploying autologous reparative peripheral nerve tissue to the substantia nigra is feasible and has not led to serious ...

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

Two-year feasibility and safety of open-label autologous ... Peripheral nerve grafts implanted into the substantia nigra in patients with Parkinson's disease during deep brain stimulation surgery: 1-year follow-up ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02369003

NCT02369003 | Cont. of a Study to Evaluate Implanting ... The intervention includes the surgical implantation of autologous peripheral nerve graft into the substantia nigra, basal forebrain, putamen, and/or STN of ...