7 Participants Needed

Sural Nerve Graft for Parkinson's Disease

(LEAP Trial)

GM
JH
Overseen ByJaimie Hixson

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

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
See 6 more

Exclusion Criteria

Unable to undergo an MRI
Typical, nonparkinsonian syndrome ioflupane/SPECT signal
I have a significant ongoing medical or mental health issue.
See 7 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nerve Graft RecipientsExperimental Treatment1 Intervention
Group II: Placebo GroupPlacebo Group1 Intervention

Find a Clinic Near You

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+

References

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. [2019]
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. [2019]
Fetal mesencephalic neurons survive and extend long axons across peripheral nervous system grafts inserted into the adult rat striatum. [2019]
Embryonic substantia nigra grafts in the mesencephalon send neurites to the host striatum in non-human primate after overexpression of GDNF. [2021]
Olfactory ensheathing glia enhances reentry of axons into the brain from peripheral nerve grafts bridging the substantia nigra with the striatum. [2011]
Transplantation of Human Neural Progenitor Cells (NPC) into Putamina of Parkinsonian Patients: A Case Series Study, Safety and Efficacy Four Years after Surgery. [2020]
Surgical treatment of Parkinson's disease. [2006]
Recipient Reaction and Composition of Autologous Sural Nerve Tissue Grafts into the Human Brain. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity