Status:
ACTIVE_NOT_RECRUITING
Feasibility and Safety of autoloGous UncondItioneD pEripheral Nerve Tissue Delivery to the Substantia Nigra (GUIDE)
Lead Sponsor:
Craig van Horne, MD, PhD
Conditions:
Parkinson's Disease
Eligibility:
All Genders
40-75 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
We recently designed open-label safety studies to investigate the use of an autologous source of cellular tissue from the peripheral nervous system (van Horne et al., 2017, 2018; Quintero et al. 2022)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05377281
Start Date
July 7 2022
End Date
June 30 2027
Last Update
October 28 2025
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536