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Mesenchymal Stromal Cells

hCT-MSC infusion for Autism Spectrum Disorder (TACT Trial)

Phase 1
Waitlist Available
Led By Joanne Kurtzberg, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial involves giving toddlers with autism a single dose of special cells from umbilical cords through their bloodstream. The study aims to see if this treatment can improve their social and communication skills. These cells might help by reducing inflammation and supporting brain development.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety of hCT-MSC infusion as measured by severity of graft vs. host disease
Safety of hCT-MSC infusion as measured by severity of infusion reactions
Safety of hCT-MSC infusion as measured by severity of product-related infections
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: hCT-MSC infusionExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
hCT-MSC infusion
2017
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,424 Previous Clinical Trials
3,066,072 Total Patients Enrolled
13 Trials studying Autism Spectrum Disorder
1,709 Patients Enrolled for Autism Spectrum Disorder
The Marcus FoundationOTHER
16 Previous Clinical Trials
1,521 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
182 Patients Enrolled for Autism Spectrum Disorder
Joanne Kurtzberg, MD5.04 ReviewsPrincipal Investigator - Duke Health
Duke University
21 Previous Clinical Trials
770 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
362 Patients Enrolled for Autism Spectrum Disorder
5Patient Review
Dr. Kurtzberg has been my physician for my entire life. I was born with an extremely rare cancer and was given 2 weeks at the most to live. Thanks to Dr. K's help in managing the side effects of the 8 chemotherapies and maximum amount of radiation one person can receive in their lifetime, I'm still here today. I'm truly grateful to have him as my doctor.
~3 spots leftby Sep 2025
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