Sural Nerve Graft for Parkinson's Disease
(LEAP Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that participants should have certain scores while off anti-parkinsonian medication. This suggests you might need to stop or adjust these medications before certain assessments.
What data supports the effectiveness of the sural nerve graft treatment for Parkinson's disease?
The study showed that implanting sural nerve grafts in Parkinson's patients during deep brain stimulation surgery was safe and feasible, with some patients experiencing improved motor function scores after one year. This suggests potential benefits, although more research is needed to confirm its effectiveness.12345
Is the sural nerve graft procedure safe for humans?
The sural nerve graft procedure, when used in Parkinson's disease patients during deep brain stimulation surgery, has been found to be generally safe. Adverse events were similar to those of standard surgery, with some patients experiencing numbness at the nerve harvest site and one case of a superficial infection.12678
How does the sural nerve graft treatment for Parkinson's disease differ from other treatments?
The sural nerve graft treatment for Parkinson's disease is unique because it involves implanting a section of the patient's own peripheral nerve, which contains Schwann cells that provide neurotrophic factors, directly into the substantia nigra during deep brain stimulation surgery. This approach aims to restore dopaminergic cell function, potentially offering a neurorestorative therapy that differs from standard treatments which do not typically involve nerve grafting.12345
What is the purpose of this trial?
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 Criteria
This trial is for early-stage Parkinson's Disease or Multiple System Atrophy patients with mild symptoms. It involves a surgical procedure where nerve tissue from the patient's own body is implanted into their brain, specifically in an area called substantia nigra.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgery to implant autologous peripheral nerve tissue into the substantia nigra or receive a sham surgery
Initial Follow-up
Participants are monitored for safety and effectiveness after surgery
Long-term Follow-up
Participants may undergo additional surgery to receive cell implants after un-blinding
Treatment Details
Interventions
- Sham surgery
- Sural Nerve Graft to the Substantia Nigra
Find a Clinic Near You
Who Is Running the Clinical Trial?
Craig van Horne, MD, PhD
Lead Sponsor
University of Kentucky CCTS
Collaborator