Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies (NCT06683365)
A Phase I Study of the Feasibility and Safety of SuraL nervE Tissue Grafting to the Substantia nigrA in Patients With Synucleinopathies (LEAP)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Kentucky — Lexington, Kentucky
Age range: 40 Years to 75 Years
🧪 Interventions in This Study
- Sural Nerve Graft to the Substantia Nigra (PROCEDURE)
- Sham surgery (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of Kentucky — Lexington, Kentucky
📞 Contact the Study Coordinator
Phone: (859) 323-1908
Email: jaimie.henderson@uky.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Multiple System Atrophy
- Randomized Double-Blind Placebo-Controlled Adaptive Design Trial Of Intrathecally Administered Autologous Mesenchymal Stem Cells In Multiple System Atrophy — Rochester, Minnesota
- A Phase 2 Study of YA-101 in Patients With Multiple System Atrophy — Los Angeles, California
- A Study of Lu AF82422 in Participants With Multiple System Atrophy — Fountain Valley, California
- GDNF Gene Therapy for Multiple System Atrophy — Irvine, California
- A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA) — Scottsdale, Arizona
- Reduction in Splanchnic Capacitance Contributes to Sympathetically Dependent Hypertension in Autonomic — Nashville, Tennessee
Explore by condition: All Multiple System Atrophy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.