NCT02720939

Brief Summary

Specific Aims:

  1. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

March 22, 2016

Last Update Submit

September 1, 2021

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • iPSC derivation and characterization

    To generate induced-pluripotent stem cells (iPSCs) from peripheral blood mononuclear cells (PBMCs) isolated from whole blood of ASD probands and healthy controls

    12 weeks

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The sample will consist of 10 ASD patients and 10 healthy controls.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

Location

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.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Susan Shur-Fen Gau, MD, PhD

    National Taiwan University Hospital & College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2016

First Posted

March 28, 2016

Study Start

January 1, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

September 2, 2021

Record last verified: 2021-09

Locations

TW(1)