Implanting nerve tissue into the brain for Parkinson's and Multiple System Atrophy
A Phase I Study of the Feasibility and Safety of SuraL nervE Tissue Grafting to the Substantia nigrA in Patients With Synucleinopathies (LEAP)
This study is testing if implanting nerve tissue into the brains of people with early-stage Parkinson's or Multiple System Atrophy can help repair damaged cells and slow down the disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 7 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT06683365 on ClinicalTrials.gov |
What this trial studies
This phase I double-blind clinical trial investigates the safety and feasibility of implanting autologous peripheral nerve tissue into the substantia nigra of patients diagnosed with Parkinson's disease or Multiple System Atrophy. The study will enroll 7 participants, with 4 receiving the nerve graft and 3 undergoing a sham surgery. Participants will be early in their diagnosis with less severe symptoms, and the trial aims to assess the potential for nerve tissue to repair damaged brain cells and slow disease progression. Follow-up will occur for one year post-surgery to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40-75 with early-stage Parkinson's disease or Multiple System Atrophy and a moderate level of symptoms.
Not a fit: Patients with advanced disease, previous surgeries for Parkinson's, or significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option that may slow the progression of Parkinson's disease and Multiple System Atrophy.
How similar studies have performed: While this approach is novel, similar studies exploring cell-based therapies for neurodegenerative diseases have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Craig van Horne, MD, PhD — University of Kentucky
- Study coordinator: Jaimie Hixson
- Email: jaimie.henderson@uky.edu
- Phone: 859-323-1908
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.