What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include medications like levodopa, dopamine agonists, MAO-B inhibitors, and surgical options such as deep brain stimulation (DBS). Levodopa can cause side effects like nausea, dizziness, and dyskinesia. Dopamine agonists may lead to compulsive behaviors, hallucinations, and sleepiness. MAO-B inhibitors can cause headaches and joint pain. DBS surgery carries risks such as infection, stroke, and hardware complications. Treatments involving Schwann cells, like the autologous peripheral nerve grafts being studied, aim to support neuron survival and function by producing growth factors. While specific side effects for these grafts are still under investigation, potential risks could include infection, immune response, or graft failure.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments for Parkinson's Disease that specifically involve the use of Schwann cells or autologous peripheral nerve grafts. Current FDA-approved treatments for Parkinson's Disease primarily include medications such as Levodopa, dopamine agonists, MAO-B inhibitors, and surgical options like Deep Brain Stimulation (DBS). These treatments focus on managing symptoms rather than modifying the disease course. The study of autologous peripheral nerve grafts, which utilize Schwann cells to produce growth factors supporting neuron survival, represents an innovative approach that is still under investigation.

What other types of research exist?

Promising novel alternatives to autologous peripheral nerve grafts for Parkinson's Disease patients include: 1) Stem cell therapies, such as human embryonic stem cell-derived neural progenitors, which have shown potential in supporting neuron survival and function. 2) Gene therapies that aim to deliver neurotrophic factors directly to the brain. 3) Advanced biologic treatments, including the use of mesenchymal stem cells secreting neurotrophic factors, which have demonstrated safety and potential efficacy in clinical trials.

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Nerve Grafts + DBS Surgery for Parkinson's Disease (CAPNG Trial)

Phase 1

Waitlist Available

Research Sponsored by Craig van Horne, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Show a positive response to Sinemet (carbidopa/levodopa)

Be able to tolerate the surgical procedure

Must not have

Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study

Unable to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety of implanting a patient's own nerve tissue into their brain during surgery for Parkinson's disease. The goal is to use natural substances from the nerve tissue to help protect and repair brain cells affected by the disease.

Who is the study for?

This trial is for people aged 40-75 with Parkinson's Disease who are already getting deep brain stimulation (DBS) surgery and respond well to Sinemet. They must be able to consent and handle the surgery. It's not for those under 40 or over 75, pregnant or breastfeeding women, or anyone unable to use birth control during the study.

What is being tested?

The study tests implanting nerve grafts from a patient's own body into their brain during DBS surgery. These grafts contain cells that might help neurons survive and function better in Parkinson’s patients.

What are the potential side effects?

Since this is a surgical procedure involving implantation of nerve tissue, potential side effects may include infection, bleeding, reaction at the implant site, and typical risks associated with any surgical intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I respond well to Sinemet medication.

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I am medically fit for surgery.

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I am receiving deep brain stimulation in specific brain areas.

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I am between 40 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, and if capable of becoming pregnant, I agree to use birth control during the study.

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I am unable to understand and agree to the study's details on my own.

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I am either younger than 40 or older than 75.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Secondary study objectives

DaTscan assessment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Peripheral Nerve GraftExperimental Treatment1 Intervention

The intervention includes the surgical implantation of autologous peripheral nerve graft into the substantia nigra, basal forebrain, putamen, and/or STN of participants with Parkinson's Disease that are undergoing Deep Brain Stimulation (DBS).

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Parkinson's Disease (PD) include medications like levodopa, which replenishes dopamine levels, and deep brain stimulation (DBS), which modulates neural activity. However, emerging therapies focus on neurotrophic support to enhance neuron survival and function. For instance, autologous peripheral nerve grafts, which include Schwann cells, produce growth factors that support neuronal health. This approach is significant for PD patients as it aims to address the underlying neurodegeneration by promoting the survival and repair of dopaminergic neurons, potentially offering a more sustainable and disease-modifying treatment compared to symptomatic relief provided by traditional therapies.

SKP-SCs transplantation alleviates 6-OHDA-induced dopaminergic neuronal injury by modulating autophagy.Long-term restoration of nigrostriatal system function by implanting GDNF genetically modified fibroblasts in a rat model of Parkinson's disease.Diminished viability, growth, and behavioral efficacy of fetal dopamine neuron grafts in aging rats with long-term dopamine depletion: an argument for neurotrophic supplementation.