10 Participants Needed

Nerve Tissue Implantation for Parkinson's Disease

(GUIDE Trial)

MY
Overseen ByMorgan Yazell, MBA
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Craig van Horne, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Peripheral Nerve Tissue Implantation for Parkinson's Disease?

Research shows that implanting peripheral nerve grafts in Parkinson's patients during deep brain stimulation surgery may improve motor function, as seen in a study where participants had better movement scores after 12 months. This suggests the treatment could have potential benefits, although more research is needed to confirm its effectiveness.12345

Is nerve tissue implantation safe for humans?

Studies on nerve tissue implantation for Parkinson's disease show it is generally safe, with adverse events similar to standard procedures. Some participants experienced numbness at the nerve harvest site, and one had a minor infection, but no serious complications were reported.13678

How does the nerve tissue implantation treatment for Parkinson's disease differ from other treatments?

This treatment involves implanting peripheral nerve tissue containing Schwann cells into the brain during deep brain stimulation surgery, aiming to restore nerve function by delivering neurotrophic factors. Unlike standard treatments, it focuses on potentially slowing disease progression by enhancing the brain's natural repair mechanisms.134910

What is the purpose of this trial?

This is an open-label, non-randomized, single-arm trial design to actively follow participants for 12 months. Ten participants will be enrolled to receive bilateral delivery of Peripheral Nerve Tissue (PNT) to the Substantia Nigra at the time of Deep Brain Stimulation (DBS) surgery. After 12 months, participants will be followed long term through annual visits for the rest of their lives. Participants will serve as their own donor for the tissue.

Research Team

Cv

Craig van Horne, MD, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for people aged 40-75 with Parkinson's Disease who are able to undergo surgery and assessments, specifically those getting Deep Brain Stimulation (DBS) surgery. They must be willing to donate their own nerve tissue and not have had previous PD or brain surgeries. Pregnant women or those not using birth control are excluded.

Inclusion Criteria

I am fit for surgery.
I am willing and able to undergo a specific brain scan.
I am between 40 and 75 years old.
See 4 more

Exclusion Criteria

I am not pregnant, breastfeeding, and if able to bear children, I agree to use birth control during the study.
Presence of typical, nonparkinsonian syndrome ioflupane/SPECT signal
My brain pathway to the substantia nigra is blocked.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants are assessed preoperatively before undergoing DBS surgery and PNT delivery

1-2 weeks

Surgery and Treatment

Participants undergo DBS surgery and bilateral delivery of autologous PNT to the substantia nigra

At the time of surgery
1 visit (in-person)

Postoperative Monitoring

Participants are assessed postoperatively at two weeks after surgery for adverse events and clinical outcomes

2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness at 6 months, 12 months, and annually thereafter

12 months
3 visits (in-person)

Long-term Follow-up

Participants are followed long term through annual visits for the rest of their lives

Long-term

Treatment Details

Interventions

  • Peripheral Nerve Tissue Implantation
Trial Overview The study tests the safety of implanting a patient's own Peripheral Nerve Tissue into their brain region called Substantia Nigra during DBS surgery. It's an open-label trial where participants will be monitored for one year post-surgery, then annually for life.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Implantation of peripheral nerve tissueExperimental Treatment1 Intervention
Bilateral deployment of peripheral nerve tissue to the substantia nigra.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Craig van Horne, MD, PhD

Lead Sponsor

Trials
5
Recruited
120+

References

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]
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. [2022]
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]
Clinical experience with cotransplantation of peripheral nerve and adrenal medulla in patients with Parkinson's disease. [2019]
Towards a neural transplantation therapy for Parkinson's disease: experimental principles from animal studies. [2019]
Cell therapy in Parkinson's disease. [2018]
Transplantation of Human Neural Progenitor Cells (NPC) into Putamina of Parkinsonian Patients: A Case Series Study, Safety and Efficacy Four Years after Surgery. [2020]
Persistent dyskinesias in patients with fetal tissue transplantation for Parkinson disease. [2021]
Enhancement of the response to levodopa therapy after intrastriatal transplantation of autologous sympathetic neurons in patients with Parkinson disease. [2014]
10.United Statespubmed.ncbi.nlm.nih.gov
The case for neural tissue transplantation as a treatment for Parkinson's disease. [2007]
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