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NCT Number: NCT05377281

Feasibility and Safety of autoloGous UncondItioneD pEripheral Nerve Tissue Delivery to the Substantia Nigra (GUIDE)

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

We recently designed open-label safety studies to investigate the use of an autologous source of cellular tissue from the peripheral nervous system (van Horne et al., 2017, 2018; Quintero et al. 2022), reparative peripheral (sural) nerve tissue containing a variety of cells and neuroprotective factors (Chau et al. 2022). While our previous studies have used injury-activated peripheral nerve tissue (PNT), where the sural nerve is transected and allowed to regenerate in situ for up to about 2 weeks before implantation, here we propose to use naïve, previously uninjured, nerve tissue delivered bilaterally to the substantia nigra at the time participants are undergoing deep brain stimulation (DBS) surgery. Participants will be assessed preoperatively, then undergo DBS surgery and delivery of autologous PNT, and then assessed postoperatively at two weeks after surgery, 6 months, 12 months and annually thereafter for adverse events and clinical outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing DBS
  • Diagnosis of clinically established or clinically probably PD (Parkinson's disease) as defined by MDS criteria
  • Age 40-75, inclusive
  • Able and willing to undergo ioflupane/SPECT
  • Able to tolerate the surgical procedure
  • Able to undergo all planned assessments
  • Available access to the sural nerve

Exclusion criteria

  • Any condition that would not make the subject a candidate for DBS
  • Previous PD surgery or intracranial surgery
  • Typical, nonparkinsonian syndrome ioflupane/SPECT signal
  • 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 undergo an MRI
  • An obstructed trajectory path to the substantia nigra

Treatment and study plan

Peripheral Nerve Tissue Implantation

Procedure

At the time participants are receiving the standard of care deep brain stimulation (DBS) surgery, a standard incision on the lateral aspect near the ankle is made, the sural nerve is identified, an about 3 cm biopsy of the sural nerve is obtained and the incision is closed. From the biopsied section, the epineurium is removed, fascicles are cut, and (~5 pieces per side; ~ 5mm length x 1.5 mm diameter: approximately 10 cubic millimeters) implanted bilaterally into the substantia nigra.

Primary outcomes

  1. Implantation of peripheral nerve tissue (PNT) into the substantia nigra

    Time frame: 12 months

    Successful bilateral graft delivery to the substantia nigra at a proportion = 70%.

Secondary outcomes

  1. Adverse Events

    Time frame: 12 months

    Number of adverse events and serious adverse events associated with bilateral PNT deployment to the substantia nigra.

  2. Deployment

    Time frame: At the time of DBS surgery

    Number of deployment attempts required to deliver bilateral PNT

  3. Procedure

    Time frame: At the time of DBS surgery

    Duration of procedure.

  4. Admission

    Time frame: Surgery

    Length of hospital stay (days).

  5. Retention

    Time frame: 12 months

    Percent of study visits completed.

  6. Change in MDS-UPDRS scores

    Time frame: 12 months

    Mean change in MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) Part III scores for participants at 12, and 6 months compared to baseline.

    Mean change of the MDS-UPDRS Part I scores for participants at 6,12 months compared to baseline.

    Mean change of the MDS-UPDRS Part II scores for participants at 6,12 months compared to baseline. (95% confidence interval) Scale runs from 0-132 with smaller scores indicating fewer symptoms.

  7. PDQ8 (Parkinson's Disease Questionnaire-8)

    Time frame: 12 months

    Mean change of the PDQ-8, Modified scores for participants at 6, 12 months compared to baseline. (95% confidence interval). Scale runs from 0-32 with lower scores indicating fewer symptoms.

  8. Schwab and England

    Time frame: 12 months

    Mean change of the Modified Schwab and England Scale scores for participants at 6, 12 months compared to baseline. (95% confidence interval). Scale runs from 0%-100% with a higher score indicating the participant has more independence in their daily activities.

  9. Neurocognitive Testing

    Time frame: 12 months post-surgery

    Mean change for neuropsychological assessment scores at 12 months compared to baseline. (95% confidence interval)

Other outcomes

  1. Specific binding ratio

    Time frame: 12 months

    Mean change in specific binding ratio in the posterior putamen for participants at 12 months compared to baseline (95% confidence interval).

Sponsors and collaborators

Lead sponsor

Craig van Horne, MD, PhD

Other

Registry information

Official study title

Feasibility and Safety of autoloGous UncondItioneD pEripheral Nerve Tissue Delivery to the Substantia Nigra

Acronym: GUIDE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 17, 2022
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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