RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I Study of the Feasibility and Safety of SuraL nervE Tissue Grafting to the Substantia nigrA in Patients With Synucleinopathies (LEAP)

Quick Facts

Study Start:2025-02-25
Study Completion:2030-12-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06683365

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of clinically established or clinically probable PD or MSA as defined by MDS criteria
  2. * Disease duration greater than 2 years
  3. * Age 40-75, inclusive
  4. * 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
  5. * 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
  6. * Able and willing to undergo ioflupane/SPECT
  7. * Able to tolerate the surgical procedure
  8. * Able to undergo all planned assessments
  9. * Available access to the sural nerve
  1. * Previous PD surgery or intracranial surgery
  2. * Ongoing major medical or psychiatric disorder incl. depression and psychosis
  3. * Other concomitant treatment with neuroleptics
  4. * Typical, nonparkinsonian syndrome ioflupane/SPECT signal
  5. * Unable to undergo an MRI
  6. * An obstructed trajectory path to the substantia nigra
  7. * Significant microvascular disease
  8. * Use of anticoagulants other than aspirin
  9. * Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study
  10. * 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.

Contacts and Locations

Study Contact

Jaimie Hixson
CONTACT
859-323-1908
jaimie.henderson@uky.edu
Group Monitored Email
CONTACT
nervegraft@uky.edu

Study Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40536
United States

Collaborators and Investigators

Sponsor: Craig van Horne, MD, PhD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-25
Study Completion Date2030-12-02

Study Record Updates

Study Start Date2025-02-25
Study Completion Date2030-12-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Multiple System Atrophy
  • Parkinsons Disease