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NCT04089579 · ClinicalTrials.gov registry record · Phase 2
hCT-MSC in Children With Autism Spectrum Disorder
A Phase 2 study of Autism Spectrum Disorder and Autism, sponsored by Joanne Kurtzberg, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 137
- Enrollment target
- 1
- Study location
NCT04089579: Completed Phase 2 study of Autism Spectrum Disorder and Autism, sponsored by Joanne Kurtzberg, MD.
NCT04089579 is a Phase 2 study of Autism Spectrum Disorder and Autism that has completed, run by Joanne Kurtzberg, MD. The registered enrollment target is 137 participants, roughly in line with the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04089579, a Phase 2 study of Autism Spectrum Disorder and Autism, has completed, sponsored by Joanne Kurtzberg, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 137 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this Phase II study is to determine the efficacy of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) for improving social communication abilities in children with autism spectrum disorder (ASD).
Primary Outcome
The primary outcome measure is the mean of the Socialization and Communication Subscale Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from the Comprehensive Interview form. The primary endpoint is the change in this outcome measure from baseline to six months before the second infusion. A positive change in the scores indicates an improvement in socialization and communication. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should b
Conditions Studied
Interventions
- OTHER Placebo Infusion
- BIOLOGICAL Cord Tissue Mesenchymal Stromal Cells
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2020-10-12 |
| Est. Completion | 2024-02-01 |
| Phase | Phase 2 |
What the finished NCT04089579 record still lists
NCT04089579 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target.
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo Infusion is the first listed.
NCT04089579 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04089579 about?
NCT04089579 is a clinical study titled "hCT-MSC in Children With Autism Spectrum Disorder". The purpose of this Phase II study is to determine the efficacy of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) for improving social communication abilities in children with autism spectrum disorder (ASD).
What is the current status of trial NCT04089579?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 137 participants. The study started on 2020-10-12. Estimated completion is 2024-02-01.
What conditions does trial NCT04089579 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Autism.
What interventions are being tested in trial NCT04089579?
The interventions under investigation include: Placebo Infusion (OTHER), Cord Tissue Mesenchymal Stromal Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT04089579?
This trial is sponsored by Joanne Kurtzberg, MD, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04089579 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04089579's enrollment target sits among peer trials
137 62nd of 224 higher than 163 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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