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

Trial Summary

What is the purpose of this trial?

The investigators propose a Phase I single surgical-center, double-blinded randomized parallel clinical trial involving bilateral autologous peripheral nerve tissue (PNT) delivery into the NBM or the alternate target also affecting cognition in this population, the substantia nigra (SN), to address "repair cell" support of these areas. Twenty-four participants with idiopathic Parkinson's Disease (PD) who have selected, qualified and agreed to receive as standard of care deep brain stimulation (DBS) will be enrolled and randomly allocated to receive bilateral PNT deployment to either the NBM or SN at the time of DBS surgery. Participants will be allocated equally among both assignments over the course of three years (8 Year 1, 10 Year 2, 6 Year 3). Participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment before surgery, two-weeks after surgery, and 6, 12, and 24 months after surgery.

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 data supports the effectiveness of the treatment Reparative Autologous peripheral nerve tissue for Parkinson's Disease?

Research shows that implanting peripheral nerve tissue into the brain during deep brain stimulation surgery is safe and may help improve motor function in Parkinson's patients. In a study, patients showed improved motor scores after 12 months, suggesting potential benefits of this treatment. ^{1 2 3 4 5}

Is peripheral nerve tissue implantation safe for humans?

Studies show that implanting peripheral nerve tissue in humans, specifically for Parkinson's disease, is generally safe. In trials, the main side effects were similar to those of standard deep brain stimulation surgery, with some participants experiencing minor numbness at the nerve harvest site. ^{1 2 4 6 7}

How is the peripheral nerve tissue implantation treatment for Parkinson's disease different from other treatments?

This treatment is unique because it involves implanting a patient's own peripheral nerve tissue, which contains Schwann cells that can provide neurotrophic factors to help restore brain function. Unlike standard treatments, it is performed during deep brain stimulation surgery and aims to deliver neurorestorative therapy directly to the brain area affected by Parkinson's disease. ^{1 2 4 5 8}

Research Team

Craig G van Horne, MD, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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.

I have had surgery for Parkinson's disease or brain surgery.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Peripheral nerve grafts implanted into the substantia nigra in patients with Parkinson's disease during deep brain stimulation surgery: 1-year follow-up study of safety, feasibility, and clinical outcome. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Recipient Reaction and Composition of Autologous Sural Nerve Tissue Grafts into the Human Brain. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Fetal mesencephalic neurons survive and extend long axons across peripheral nervous system grafts inserted into the adult rat striatum. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Implantation of autologous peripheral nerve grafts into the substantia nigra of subjects with idiopathic Parkinson's disease treated with bilateral STN DBS: a report of safety and feasibility. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Nerve-cell grafting in Parkinson's disease. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Cell therapy in Parkinson's disease. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical experience with cotransplantation of peripheral nerve and adrenal medulla in patients with Parkinson's disease. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Role of the Peripheral Nervous System in PD Pathology, Diagnosis, and Treatment. [2021]