hCT-MSC in Children With Autism Spectrum Disorder (NCT04089579) | Clinical Trial Compass
CompletedPhase 2
hCT-MSC in Children With Autism Spectrum Disorder
United States137 participantsStarted 2020-10-12
Plain-language 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).
Who can participate
Age range4 Years – 11 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 4 years to \< 12 years (11 years, 364 days) at the time of consent
✓. Confirmed clinical DSM-5 diagnosis of Autism Spectrum Disorder using the DSM-5 Checklist as informed by the Brief Observation of Symptoms of Autism (BOSA) and the Autism Diagnostic Interview-Revised (ADI-R)
✓. Fragile X testing performed and negative; CMA and/or whole exome sequencing performed and results not linked to autism diagnosis
✓. Stable on current psychiatric medication regimen (dose and dosing schedule) for at least 2 months prior to infusion of study product
✓. Normal absolute lymphocyte count (≥1200/uL for African American participants and ≥1500/uL for all other participants)
✓. GAI ≥ 65 via cognitive testing by study personnel
✓. Participant and parent/guardian are English speaking
✓. Able to travel to Duke University two times (baseline, six months), and parent/guardian is able to participate in interim surveys and interviews
Exclusion criteria
✕. General:
✕. Review of medical records and/or screening assessments indicates ASD diagnosis and/or GAI \> 65 not confident
✕. Known diagnosis of any of the following coexisting psychiatric conditions: depression, bipolar disorder, schizophrenia, obsessive compulsive disorder associated with bipolar disorder, Tourette syndrome
What they're measuring
1
Change on the Socialization and Communication Subscale Standard Scores on the Vineland Behavior Scales
✕. Screening data suggests that participant would not be able to comply with the requirements of the study procedures as assessed by the study team
✕. Family is unwilling or unable to commit to participation in all study-related assessments, including protocol follow up
✕. Sibling is enrolled in this (Duke IMPACT) study
✕. Genetic:
✕. Records indicate that child has a known genetic syndrome such as (but not limited to) Fragile X syndrome, neurofibromatosis, Rett syndrome, tuberous sclerosis, PTEN mutation, cystic fibrosis, muscular dystrophy or a genetic defect definitively known to be associated with ASD