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NCT02176317 · ClinicalTrials.gov registry record · Phase 1
Autologous Umbilical Cord Blood Infusion for Children With Autism Spectrum Disorder (ASD)
A Phase 1 study of Autism Spectrum Disorder, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT02176317 is a Phase 1 study of Autism Spectrum Disorder that has completed, run by Duke University. The registered enrollment target is 25 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02176317, a Phase 1 study of Autism Spectrum Disorder, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a prospective phase 1 single-center trial designed to determine the safety of a single intravenous infusion of autologous umbilical cord blood in children with Autism Spectrum Disorder (ASD) and assess the feasibility of various outcome measures to determine which measure(s) can be used as primary and secondary endpoints for a future randomized phase 2 clinical trial. All subjects will receive infusion of cord blood cells at baseline with follow up assessments at 6 and 12 months.
Conditions Studied
Interventions
- BIOLOGICAL Autologous Umbilical Cord Blood
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02176317
The ClinicalTrials.gov registry entry for NCT02176317 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (81% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which Autologous Umbilical Cord Blood is the first listed.
NCT02176317 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT02176317 about?
NCT02176317 is a clinical study titled "Autologous Umbilical Cord Blood Infusion for Children With Autism Spectrum Disorder (ASD)". This study is a prospective phase 1 single-center trial designed to determine the safety of a single intravenous infusion of autologous umbilical cord blood in children with Autism Spectrum Disorder (ASD) and assess the feasibility of various outcome measures to determine which measure(s) can be use...
What is the current status of trial NCT02176317?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2014-06. Estimated completion is 2015-12.
What conditions does trial NCT02176317 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder.
What interventions are being tested in trial NCT02176317?
The interventions under investigation include: Autologous Umbilical Cord Blood (BIOLOGICAL).
Who is sponsoring clinical trial NCT02176317?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02176317 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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