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NCT04294290 · ClinicalTrials.gov registry record · Phase 1
Open Label Phase I hCT-MSC in Toddlers With Autism Spectrum Disorder
A Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04294290 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 12 participants.
The verdict
NCT04294290, a Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a single site, prospective study of one intravenous infusion of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in toddlers with autism spectrum disorder (ASD). Toddlers 18 to 48 months of age with a confirmed diagnosis of ASD will be eligible to participate. Diagnosis will be confirmed at the time of the eligibility visit at the Duke Center for Autism and Brain Development. All participants will receive a single intravenous dose of 2x106/kg hCT-MSC per kilogram at baseline. Assessments will be conducted at baseline and 6 months, with remote follow-up assessments at 12 months.
Interventions
- BIOLOGICAL hCT-MSC infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-02-24 |
| Est. Completion | 2022-08-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04294290
The ClinicalTrials.gov registry entry for NCT04294290 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which hCT-MSC infusion is the first listed.
NCT04294290 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04294290 about?
NCT04294290 is a clinical study titled "Open Label Phase I hCT-MSC in Toddlers With Autism Spectrum Disorder". This is a single site, prospective study of one intravenous infusion of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in toddlers with autism spectrum disorder (ASD). Toddlers 18 to 48 months of age with a confirmed diagnosis of ASD will be eligible to participate. Diagnosi...
What is the current status of trial NCT04294290?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2021-02-24. Estimated completion is 2022-08-17.
What interventions are being tested in trial NCT04294290?
The interventions under investigation include: hCT-MSC infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT04294290?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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