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Trial record 11 of 19 for:    stem cells and autism

ASD-specific Induced Pluripotent Stem Cells for Disease Modeling

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ClinicalTrials.gov Identifier: NCT02720939
Recruitment Status : Unknown
Verified March 2016 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : March 28, 2016
Last Update Posted : March 28, 2016
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

Specific Aims:

  1. To generate induced-pluripotent stem cells (iPSCs) from peripheral blood mononuclear cells (PBMCs) isolated from whole blood of ASD probands and healthy controls.
  2. To derive neural progenitor cells (NPCs) and neurons from iPSCs of ASD probands and healthy controls and compare differences between patients and healthy controls to investigate the cellular phenotype of ASD and uncover the pathophysiology of the disease.

Condition or disease
Autism Spectrum Disorder

Detailed Description:

Autism spectrum disorders (ASDs) is a common, lifelong impairing childhood-onset neurodevelopmental disorder with clinical and genetic heterogeneity. The etiology of ASD is complicated and remains largely unknown. Evidences indicate the high heritability (54-77%) in ASD, and researchers also found copy number variations (CNVs) play an important role in the etiology of ASD. However, due to the ethical issue, researchers haven't had an appropriate platform to investigate the copy number change effect to date. In the following study, researchers are going to derive ASD-specific induced pluripotent stem cells and neurons for disease modeling.

10 ASD patients and 10 healthy controls will be included in the present study and iPSCs and neurons will be generated from their PBMCs. Electrophysiological recording and analysis of neuronal morphology will be conducted to reveal the cellular phenotype of ASD after comparing differences between patients and healthy controls.

The study will provide a platform to reveal the etiology of genetic basis and molecular mechanism of ASD. The cellular phenotype of ASD will be revealed by comparing differences between patients and healthy controls. The findings from this work are expected to contribute to the basic and clinical research on ASD.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: ASD-specific Induced Pluripotent Stem Cells for Disease Modeling
Study Start Date : January 2016
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort
ASD group
ASD patients who met the diagnostic criteria of either autistic disorder or Asperger's disorder defined by the DSM-IV criteria
TD group
Typically development controls without lifetime diagnosis with ASD or any psychiatric disorders



Primary Outcome Measures :
  1. iPSC derivation and characterization [ Time Frame: 12 weeks ]
    To generate induced-pluripotent stem cells (iPSCs) from peripheral blood mononuclear cells (PBMCs) isolated from whole blood of ASD probands and healthy controls


Biospecimen Retention:   Samples With DNA
Peripheral blood will be collected in the INSEPACK Disposable Vacuum Venous Blood Specimen collection Tube (Green Tube with li-Heparin) and each tube will contain 5-10ml of blood from ASD probands and healthy controls.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The sample will consist of 10 ASD patients and 10 healthy controls.
Criteria

Inclusion Criteria:

  • ASD group: Subjects who met the diagnostic criteria of either autistic disorder or Asperger's disorder defined by the DSM-IV criteria.

Exclusion Criteria:

  • TD group: Subjects with any current or lifetime DSM-IV psychiatric disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720939


Contacts
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Contact: Susan Shur-Fen Gau, MD, PhD 886-2-23123456 ext 66802 gaushufe@ntu.edu.tw

Locations
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Taiwan
National Taiwan Univeristy Hospital Recruiting
Taipei, Taiwan
Contact: Susan Shur-Fen Gau, MD, PhD    886-2-23123456 ext 66802    gaushufe@ntu.edu.tw   
Principal Investigator: Wei-Chih Kao, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Susan Shur-Fen Gau, MD, PhD National Taiwan University Hospital & College of Medicine

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02720939     History of Changes
Other Study ID Numbers: 201507086RINA
First Posted: March 28, 2016    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders