Recruiting
Phase 1

SuraL Nerve Grafting

Sponsor:

Craig van Horne, MD, PhD

Code:

NCT06683365

Conditions

Multiple System Atrophy

Parkinsons Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Sural Nerve Graft to the Substantia Nigra

Sham surgery

Study Details

Brief summary:

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.

Conditions

Multiple System Atrophy

Parkinsons Disease

Study ID

NCT06683365

Start date

Feb 25, 2025

Status verified date

Aug, 2026

Completion date

Dec 2, 2030

Anticipated

Primary completion date

Dec 2, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of clinically established or clinically probable PD or MSA as defined by MDS criteria
  • Disease duration greater than 2 years
  • Age 40-75, inclusive
  • MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III greater than or equal to 20 points but less than or equal to 35 points, off anti-parkinsonian medication for PD or MDS-Unified Multiple System Atrophy Rating Scale (UMSARS) less than or equal to 30 points off anti-parkinsonian medication
  • No MDS-UPDRS Part III score >3 on items 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.14 while off medication
  • 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:

  • Previous PD surgery or intracranial surgery
  • Ongoing major medical or psychiatric disorder incl. depression and psychosis
  • Other concomitant treatment with neuroleptics
  • Typical, nonparkinsonian syndrome ioflupane/SPECT signal
  • Unable to undergo an MRI
  • An obstructed trajectory path to the substantia nigra
  • Significant microvascular disease
  • Use of anticoagulants other than aspirin
  • Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study
  • Consent capacity will be assessed and determined during and throughout a participant's neuropsychological exam. A participant who experiences a decline in consent capacity prior to surgery, will be removed from the study by the PI. A decline in consent capacity after surgery will not result in the removal of the participant in the study.

Study Design

Enrollment

7 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nerve Graft Recipients

placebo comparator: Placebo Group

Interventions

Sural Nerve Graft to the Substantia Nigra

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jaimie Hixson

859-323-1908jaimie.henderson@uky.edu

Group Monitored Email

nervegraft@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Jaimie Hixson

859-323-1908jaimie.henderson@uky.edu

Principal Investigator:

Craig van Horne, MD, PhD

More Information

Sponsor

Craig van Horne, MD, PhD

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Synucleinopathies
  • Cell and Tissue Based Therapy
  • Multiple System Atrophy
  • Parkinsons Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Craig van Horne, MD, PhD on 2026-08-31.