CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 137 enrolled / 137 target
Drug / intervention
Cord Tissue Mesenchymal Stromal Cells +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04089579
NCT04089579Phase 2CompletedHigh Momentum (2.0/mo)Completion was 38mo ago
CompareCT.gov

A Phase II Study of hCT-MSC, an Umbilical Cord-Derived Mesenchymal Stromal Cell Product, in Children With Autism Spectrum Disorder

Joanne Kurtzberg, MD·interventional·Posted Sep 13, 2019·Updated Jun 24, 2026

In Brief

A Phase 2 clinical trial evaluating Cord Tissue Mesenchymal Stromal Cells and Placebo Infusion for Autism and Autism Spectrum Disorder. Completed, enrolled 137 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism, Autism Spectrum Disorder
CountriesUnited States
CollaboratorsThe Marcus Foundation, Cryo-Cell International

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedSep 13, 2019
Enrollment StartOct 12, 2020
Primary CompletionMay 2, 2023
Study CompletionFeb 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.8 years ago

Arms & Interventions

MSCexperimental

One dose of 6x10e6 cells/kg administered intravenously.

Biological: Cord Tissue Mesenchymal Stromal Cells
Placebo Infusionplacebo_comparator

Placebo infusion

Other: Placebo Infusion

Interventions

Cord Tissue Mesenchymal Stromal Cellsbiological

Human Umbilical Cord Tissue Derived Mesenchymal Stromal Cells (hCT-MSC), isolated and expanded from umbilical cord tissue from allogeneic unrelated donors. One dose of 6x10e6 cells/kg administered intravenously.

Placebo Infusionother

Placebo comparative infusion