RecruitingPhase 1NCT06683365

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

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

Sponsor

Craig van Horne, MD, PhD

Enrollment

7 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple System Atrophy Parkinsons Disease

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.

Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether transplanting a small nerve from your leg (the sural nerve) into the part of the brain affected by Parkinson's disease or Multiple System Atrophy might help slow disease progression or improve symptoms. **You may be eligible if...** - You have been diagnosed with Parkinson's disease (PD) or Multiple System Atrophy (MSA) - You have had the disease for more than 2 years - You are between 40 and 75 years old - Your motor symptoms are in a moderate range (not too mild, not too severe) when off medication - You are able to undergo brain surgery and an MRI - You are willing to undergo a type of brain scan called a SPECT scan **You may NOT be eligible if...** - You have had previous brain surgery or Parkinson's-related surgery - You have a serious psychiatric condition such as depression or psychosis - You take antipsychotic (neuroleptic) medications - You have significant small blood vessel disease - You use blood thinners (other than aspirin) - You are pregnant or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURESural 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.

PROCEDURESham 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.