Molecular Characterization of Induced Neuronal Cells in Parkinson's Disease

March 21, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Molecular Characterization of Induced Neuronal Cells Derived From Fibroblasts of Patients With Parkinson's Disease

To describe the molecular, electrophysiological and morphological expression profile of dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects aged 18 years or older
  2. Patients with Parkinson's disease, according to the most recent diagnostic criteria
  3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Exclusion Criteria:

  1. Patients affected by drug-induced parkinsonism or atypical parkinsonian disorders
  2. Patients with neurological diseases other than Parkinson's disease
  3. Inability to sign an informed consent
  4. Severe psychiatric diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skin biopsy
Procedure: Skin biopsy
Punch biopsy of the skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurophysiological characterization of dopaminergic neurons derived from patients with Parkinson's disease.
Time Frame: Baseline
To evaluate the firing frequency in the dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease.
Baseline
Biochemical characterization of dopaminergic neurons derived from patients with Parkinson's disease.
Time Frame: Baseline
To determine the amount of dopamine released from differentiated neurons derived from fibroblasts of patients with Parkinson's disease.
Baseline
α-synuclein misfolding in dopaminergic neurons derived from patients with Parkinson's disease.
Time Frame: Baseline
To document the presence of abnormal accumulation of misfolded alpha-synuclein in the dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2021

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

March 25, 2025

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3482

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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