A Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Brain for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery (STAR)

Craig van Horne, MD, PhD

Status and phase: Enrolling; Phase 1

Conditions: Parkinson's Disease

Treatments: Procedure: Reparative Autologous peripheral nerve tissue

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06683378

90066

1R01AG081356-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing DBS
• Diagnosis of clinically established or clinically probably PD as defined by MDS criteria
• Age 45-75, inclusive
• Able to tolerate the surgical procedure
• Able to undergo all planned assessments
• Available access to the sural nerve

Exclusion criteria

• Any condition that would not make the subject a candidate for DBS
• Dementia diagnosis
• Previous PD surgery or intracranial surgery
• Unable to undergo an MRI
• An obstructed trajectory path to the substantia nigra and nucleus basalis of Meynert

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

24 participants in 2 patient groups

Peripheral nerve tissue (PNT) deployment to the Substantia Nigra

Active Comparator group

Treatment:

Procedure: Reparative Autologous peripheral nerve tissue

Peripheral nerve tissue (PNT) deployment to the nucleus basalis of Meynert

Active Comparator group

Treatment:

Procedure: Reparative Autologous peripheral nerve tissue