Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Craig van Horne, MD, PhD
Study ID
NCT06683365
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Sural Nerve Graft to the Substantia Nigra — PROCEDURE
    Participants assigned to this arm will have the sural nerve biopsied from one of their ankles. This cellular tissue will be deposited bilaterally into the substantia nigra area of their brain by a specialized cannula via bilateral scalp incisions and skull burr holes.
  • Sham surgery — PROCEDURE
    Participants assigned to this arm will have the sural nerve from one of their ankles biopsied in the same fashion as the experimental arm. Bilateral incisions will be made on the participants scalp but no burr holes into the skull and no cannula passes into the brain will occur.

Study Details

This phase I double-blind study focuses on the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the substantia nigra area of the brain in persons who have been diagnosed with either Parkinson's disease (PD) or Multiple System Atrophy (MSA). 7 participants will be enrolled, with 4 participants receiving the graft and 3 receiving a sham surgery. Eligible participants will be early in their diagnosis with a lower burden of symptoms. Participants will be followed initially for one year after surgery.

Key Dates

Start date
Feb 25, 2025
Status verified
Mar 2026
Primary completion
Dec 2, 2028
Completion
Dec 2, 2030

Study Design

Enrollment
7 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nerve Graft Recipients
  • Placebo Comparator: Placebo Group

Primary Outcome Measure

Meet recruitment goal [ Time Frame: Trial opening through 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40536
Jaimie Hixson
[email protected]
859-323-1908
Craig van Horne, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lexington, KY

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Kentucky· Lexington, KY

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