Recruiting · registry statusTesting a person’s own nerve tissue as a brain graft
This early study checks the safety and practicality of placing a person’s own nerve tissue into a brain area affected by Parkinson’s-related conditions.
Testing a treatment or activity · Study reference: NCT06683365
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
Open the official registry record ↗Follow this study
Results reported
- Start (reported actual date)
- 2025-02-25
- Main measurements finished (planned)
- 2028-12-02
- Study finished (planned)
- 2030-12-02
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
Quintero JE, Slevin JT, Gurwell JA, McLouth CJ, El Khouli R, Chau MJ, Guduru Z, Gerhardt GA, van Horne CG. Direct delivery of an investigational cell therapy in patients with Parkinson's disease: an interim analysis of feasibility and safety of an open-label study using DBS-Plus clinical trial design. BMJ Neurol Open. 2022 Jul 14;4(2):e000301. doi: 10.1136/bmjno-2022-000301. eCollection 2022. ↗
Registry results reference
van Horne CG, Quintero JE, Gurwell JA, Wagner RP, Slevin JT, Gerhardt GA. Implantation of autologous peripheral nerve grafts into the substantia nigra of subjects with idiopathic Parkinson's disease treated with bilateral STN DBS: a report of safety and feasibility. J Neurosurg. 2017 Apr;126(4):1140-1147. doi: 10.3171/2016.2.JNS151988. Epub 2016 May 6. ↗
Registry results reference
van Horne CG, Quintero JE, Slevin JT, Anderson-Mooney A, Gurwell JA, Welleford AS, Lamm JR, Wagner RP, Gerhardt GA. Peripheral nerve grafts implanted into the substantia nigra in patients with Parkinson's disease during deep brain stimulation surgery: 1-year follow-up study of safety, feasibility, and clinical outcome. J Neurosurg. 2018 Dec 1;129(6):1550-1561. doi: 10.3171/2017.8.JNS163222. Epub 2018 Feb 18. ↗
Registry results reference
Who can join?
Ages 40 years to 75 years · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
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.
Full study name & original research details
Official study title
A Phase I Study of the Feasibility and Safety of SuraL nervE Tissue Grafting to the Substantia nigrA in Patients With Synucleinopathies (LEAP)
Short title used by the registry
Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies
Original 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.
Further description from the registry
This phase I double blind clinical trial will be used to plan future, larger clinical trials that would test how autologous cells from the peripheral nerve may help in the repair of damaged brain cells in Parkinson's Disease (PD) or Multiple System Atrophy (MSA) and slow the progression of the diseases. We will be judging the feasibility of implanting a participant's own cells from a nerve in the leg into the substantia nigra area of the brain. Patients eligible for participation will be at an earlier in stage of the disease with symptoms being less severe and therefore would not yet qualify for DBS. The LEAP trial is a study where the first participant will receive an implantation of the cells from their own sural nerve (a nerve near the ankle), into the substantia nigra on both sides of their brain. The 6 participants who follow, will be randomized to one of two arms. The 3 participants assigned to the experimental arm will receive the graft. The 3 participants assigned to the control arm will receive a sham surgical procedure, where the sural nerve will be biopsied, and bilateral scalp incisions will be made. Those who do not receive the cells initially may be eligible to undergo another surgery at the end of the study, after un-blinding has occurred, to receive the cell implants.
Conditions reported: Multiple System Atrophy; Parkinsons Disease
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- Sural Nerve Graft to the Substantia Nigra; Sham surgery
- Phases
- PHASE1
- Sponsor
- Craig van Horne, MD, PhD
- Start date reported by registry
- 2025-02-25 (actual)
Registry updated: 2026-08-31 · Status last verified by the registry submitter: 2026-08
Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Jaimie Hixson · 859-323-1908 · jaimie.henderson@uky.edu
Group Monitored Email · nervegraft@uky.edu
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
University of Kentucky
Lexington, Kentucky, United States
RecruitingJaimie Hixson · 859-323-1908 · jaimie.henderson@uky.edu
Craig van Horne, MD, PhD
The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.