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Feasibility and Safety of autoloGous UncondItioneD pEripheral Nerve Tissue Delivery to the Substantia Nigra (GUIDE)

Active Not RecruitingPhase 1

Sponsor: Craig van Horne, MD, PhD

Conditions: Parkinson's Disease

Interventions: Peripheral Nerve Tissue Implantation

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 40 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Undergoing DBS
* Diagnosis of clinically established or clinically probably PD (Parkinson's disease) as defined by MDS criteria
* Age 40-75, inclusive
* Able and willing to undergo ioflupane/SPECT
* 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
* Previous PD surgery or intracranial surgery
* Typical, nonparkinsonian syndrome ioflupane/SPECT signal
* Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study
* Unable to undergo an MRI
* An obstructed trajectory path to the substantia nigra

Locations (1)

Lexington, Kentucky, United States