Sural Nerve Graft for Parkinson's Disease

(LEAP Trial)

Overseen By Jaimie Hixson

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Craig van Horne, MD, PhD

Must not be taking: Neuroleptics, Anticoagulants

Disqualifiers: Previous PD surgery, Major psychiatric disorder, others

Compensation: Varies

Number of Visits: 1

Duration: During the procedure

7 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with Parkinson's disease (PD) or Multiple System Atrophy (MSA). Researchers aim to determine if implanting tissue from a person's own sural nerve (a nerve from the leg) into the substantia nigra, a specific part of the brain, is safe and feasible. Some participants will receive the actual nerve graft, while others will undergo a sham (fake) surgery for comparison. Ideal participants have had PD or MSA for more than two years and are in the early stages, experiencing fewer symptoms. The study will monitor participants for one year after surgery to gather results. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

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 prior data suggests that this nerve graft is safe for Parkinson's disease?

In a previous study, researchers examined the safety and effects of placing sural nerve grafts into the brain, specifically in the substantia nigra area, and monitored participants for 12 months. The results showed that the procedure was generally well-tolerated, with most participants not experiencing serious side effects. However, some experienced mild issues at the site where the nerve tissue was taken, such as soreness or numbness.

Another study with four participants who received small pieces of their own sural nerve tissue showed similar results. The treatment did not cause major problems and was deemed safe enough for further research.

As an early-phase study, the primary focus is on assessing whether the treatment is safe to explore further. This type of study represents the first step in testing a new treatment in humans. While the safety data appears promising, researchers continue to study it carefully to ensure it’s safe for more people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's disease?

Unlike the standard treatments for Parkinson's Disease, which often include medications like levodopa and dopamine agonists to manage symptoms, the sural nerve graft targets the disease differently. This innovative approach involves transplanting a nerve graft into the substantia nigra, the brain area affected in Parkinson's, aiming to restore or replace lost nerve function. Researchers are excited about this because it may offer a way to address the underlying nerve damage rather than just alleviating symptoms. This could potentially lead to more significant and lasting improvements for patients.

What evidence suggests that the sural nerve graft might be an effective treatment for Parkinson's disease?

Research has shown that using sural nerve grafts in areas of the brain affected by Parkinson's disease yields promising early results. In past studies, patients who received these grafts during surgery found the procedure safe and feasible. Some patients even noticed improvements in their condition, suggesting potential benefits. In this trial, participants in the "Nerve Graft Recipients" arm will receive the sural nerve graft to the substantia nigra, while those in the "Placebo Group" will undergo sham surgery. Although these findings are preliminary, they highlight the possibility of nerve grafts helping to manage Parkinson's disease symptoms and warrant further research. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

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

I am willing and able to undergo a specific brain scan.

I have been diagnosed with Parkinson's disease or multiple system atrophy.

Able to undergo all planned assessments

Exclusion Criteria

Unable to undergo an MRI

Typical, nonparkinsonian syndrome ioflupane/SPECT signal

I have a significant ongoing medical or mental health issue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery to implant autologous peripheral nerve tissue into the substantia nigra or receive a sham surgery

During the procedure

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and effectiveness after surgery

12 months

Monthly visits (in-person)

Long-term Follow-up

Participants may undergo additional surgery to receive cell implants after un-blinding

Post 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Sham surgery
• Sural Nerve Graft to the Substantia Nigra

Trial Overview The study tests the safety of transplanting one's own sural nerve to the brain region affected by Parkinson's and MSA versus a sham surgery (a pretend operation). Out of 7 participants, 4 will get the actual surgery and 3 will have sham surgery, followed up for one year.

How Is the Trial Designed?

Group I: Nerve Graft Recipients Experimental Treatment 1 Intervention

Group II: Placebo Group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Craig van Horne, MD, PhD

Lead Sponsor

Trials

5

Recruited

120+

University of Kentucky CCTS

Collaborator

Trials

2

Recruited

70+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06683365

Autologous suraL nervE Grafting to the Substantia nigrA in ... This phase I double-blind study focuses on the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the substantia nigra area ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10573749

Recipient Reaction and Composition of Autologous Sural ... We present data from four participants who received autologous transplantation of small pieces of sural nerve tissue into either the basal ...

3. withpower.com withpower.com/trial/phase-1-parkinsons-disease-11-2024-112ae

Sural Nerve Graft for Parkinson's Disease (LEAP Trial) The study showed that implanting sural nerve grafts in Parkinson's patients during deep brain stimulation surgery was safe and feasible, with some patients ...

4. thejns.org thejns.org/view/journals/j-neurosurg/129/6/article-p1550.xml

Peripheral nerve grafts implanted into the substantia nigra in ... This study presents the full experience of the clinical trial that enrolled 8 participants and the clinical outcome data at 1-year ...

5. scholars.uky.edu scholars.uky.edu/en/publications/peripheral-nerve-grafts-implanted-into-the-substantia-nigra-in-pa

Peripheral nerve grafts implanted into the substantia nigra in ... Clinical outcome data from this phase I trial suggests that grafting may have some clinical benefit and certainly warrants further study to determine if this is ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29451447/

Peripheral nerve grafts implanted into the substantia nigra in ... This study presents a 12-month evaluation of safety and feasibility, as well as the clinical response, of implanting autologous peripheral nerve grafts into ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/555036

Autologous suraL nervE Grafting to the Substantia nigrA in ... This phase I double-blind study focuses on the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the ...