Clinical trial
Fetched
Post
clinicaltrials.gov
Duke University, The Marcus Foundation
(2021).
Open Label Phase I hCT-MSC in Toddlers With Autism Spectrum Disorder.
ClinicalTrials.gov.
Duke University.
- Publication date
-
24 Feb 2021
- Identifier
-
NCT04294290
- Authors
-
Duke University,
The Marcus Foundation
- Source
- ClinicalTrials.gov
- Reference type
- clinical_trial
- Publisher
- Duke University
- Metadata source
- clinicaltrials.gov
Abstract
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.