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hCT-MSC in Children With Autism Spectrum Disorder

NCT04089579 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2024-02-14

No results posted yet for this 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).

Conditions

Interventions

BIOLOGICAL

Cord Tissue Mesenchymal Stromal Cells

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.

OTHER

Placebo Infusion

Placebo comparative infusion

Sponsors & Collaborators

  • The Marcus Foundation

    collaborator OTHER

  • Cryo-Cell International

    collaborator UNKNOWN

  • Joanne Kurtzberg, MD

    lead OTHER

Principal Investigators

  • Beth Shaz, MD · Duke University

  • Lauren Franz, MBChB · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-12
Primary Completion
2023-05-02
Completion
2024-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04089579 on ClinicalTrials.gov