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

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.

Conditions

Multiple System Atrophy, Parkinsons Disease

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Multiple System Atrophy
Intervention / Treatment

-

Contacts and Locations

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40536

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

40 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Craig van Horne, MD, PhD,

Study Record Dates

2030-12-02