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Tissue Therapy

Nerve Tissue Implantation for Parkinson's Disease (GUIDE Trial)

Phase 1
Recruiting
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
Able to tolerate the surgical procedure
Able and willing to undergo ioflupane/SPECT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

GUIDE Trial Summary

This trialstudies a new surgery to treat Parkinson's Disease with donor tissue from the same person. 10 people will be followed for 12 months, then annually for life.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed, potential risks may include complications from surgical procedures such as infection, bleeding, reaction to anesthesia, and any unique adverse events related to the implanted nerve tissue.

GUIDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fit for surgery.
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I am willing and able to undergo a specific brain scan.
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I am between 40 and 75 years old.
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I have been diagnosed with Parkinson's disease.
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My sural nerve can be accessed for medical purposes.

GUIDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Implantation of peripheral nerve tissue (PNT) into the substantia nigra
Secondary outcome measures
Admission
Adverse Events
Change in MDS-UPDRS scores
+6 more
Other outcome measures
Specific binding ratio

GUIDE Trial Design

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 Location

Who is running the clinical trial?

Craig van Horne, MD, PhDLead Sponsor
2 Previous Clinical Trials
78 Total Patients Enrolled

Media Library

Peripheral Nerve Tissue Implantation (Tissue Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05377281 — Phase 1
Parkinson's Disease Research Study Groups: Implantation of peripheral nerve tissue
Parkinson's Disease Clinical Trial 2023: Peripheral Nerve Tissue Implantation Highlights & Side Effects. Trial Name: NCT05377281 — Phase 1
Peripheral Nerve Tissue Implantation (Tissue Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05377281 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to take part in this clinical research?

"The requirements for inclusion into this medical trial are a diagnosis of Parkinson's disease (PD) and an age between 40 and 75. Currently, 10 individuals need to be recruited."

Answered by AI

What ultimate goals are scientists attempting to accomplish with this clinical experiment?

"This experiment seeks to evaluate the efficacy of introducing nerve grafts into the brain, with a timeline of 12 months. Secondary objectives include assessing the number of deployment attempts necessary to deliver bilateral PNT; changes in MDS-UPDRS (Movement Disorder Society - Unified Parkinson's disease Rating Scale) Part III scores after 6 and 12 months compared to baseline; alteration in Mean change of Modified Schwab and England Scores following 6 and 12 months relative to baseline. These scales range from 0-132 or 0%-100%, respectively, where lower numbers/higher percentages indicate fewer symptoms/more independence."

Answered by AI

What is the upper limit to the number of individuals participating in this experiment?

"Affirmative. The information provided on clinicaltrials.gov indicates that this research is now recruiting individuals for participation. It was initially posted on July 7th 2022 with the most recent update having occurred November 10th 2022, and it intends to enrol a total of 10 patients from 1 site."

Answered by AI

Is it possible to join the current cohort of participants for this experiment?

"Affirmative, the details hosted on clinicaltrials.gov demonstrate that this medical trial is actively recruiting participants. It was first listed on July 7th 2022 and has been updated most recently on November 10th 2021. This study necessitates the enrollment of 10 patients at one location."

Answered by AI

Is Implantation of peripheral nerve tissue a safe procedure for individuals?

"The relative safety of peripheral nerve tissue implantation is assessed at a 1 as this trial currently runs in its first phase, and thus only possesses limited data for both efficacy and security."

Answered by AI

Do individuals aged 50 or above qualify to partake in this trial?

"This clinical trial seeks to recruit participants aged between 40 and 75 years old. Alternatively, 27 studies are available for those under 18 while 482 can be found for people over the age of 65."

Answered by AI
~7 spots leftby Jun 2027