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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 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.

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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).

Interventions

  • OTHER Placebo Infusion
  • BIOLOGICAL Cord Tissue Mesenchymal Stromal Cells

Study Locations (1)

North Carolina

  • Duke University Medical Center - Durham

Trial Details

FieldValue
Enrollment Target 137 participants
Start Date 2020-10-12
Est. Completion 2024-02-01
Phase Phase 2

Sponsor

Joanne Kurtzberg, MD

15 total trials

What the Registry Record Tells You About NCT04089579

The ClinicalTrials.gov registry entry for NCT04089579 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target. The listed sponsor is Joanne Kurtzberg, MD, which has 15 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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