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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
Age ≥ 18 months to ≤ 48 months (48 months, 29 days) at the time of consent
Confirmed clinical DSM-5 diagnosis of Autism Spectrum Disorder using the DSM-5 Checklist as informed by the Autism Diagnostic Observation Schedule - 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

TACT Trial Summary

This trial will test the safety and effectiveness of a single infusion of hCT-MSC in toddlers with ASD.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism

TACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

TACT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Clinical Global Impression Scale (CGI)
Change in Communicative Development Inventories (CDI-2)
Change in PDD Behavior Inventory Autism Composite Score (PDDBI)
+12 more

TACT 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
2,351 Previous Clinical Trials
3,409,534 Total Patients Enrolled
12 Trials studying Autism Spectrum Disorder
1,637 Patients Enrolled for Autism Spectrum Disorder
The Marcus FoundationOTHER
15 Previous Clinical Trials
1,488 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
185 Patients Enrolled for Autism Spectrum Disorder
Joanne Kurtzberg, MD5.04 ReviewsPrincipal Investigator - Duke Health
Duke University
21 Previous Clinical Trials
773 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
365 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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025