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Stem Cell Therapy

Autologous Umbilical Cord Blood (UCB) for Autism Spectrum Disorder

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 up to 12 months
Awards & highlights

Summary

This study is a prospective phase 1 single-center trial designed to determine the safety of a single intravenous infusion of autologous umbilical cord blood in children with Autism Spectrum Disorder (ASD) and assess the feasibility of various outcome measures to determine which measure(s) can be used as primary and secondary endpoints for a future randomized phase 2 clinical trial. All subjects will receive infusion of cord blood cells at baseline with follow up assessments at 6 and 12 months.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with non-serious and serious adverse events.
Secondary outcome measures
The primary efficacy measure will be change in the Vineland Adaptive Behavior Scale- II
Other outcome measures
Change in Aberrant Behavior Checklist
Change in Autism Diagnostic Observation Scale
Change in Behavior Assessment of Children
+11 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Autologous Umbilical Cord Blood (UCB)Experimental Treatment1 Intervention
All participants will receive a single intravenous (into the vein) infusion of autologous umbilical cord blood cells.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous Umbilical Cord Blood
2014
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,394 Previous Clinical Trials
3,059,461 Total Patients Enrolled
13 Trials studying Autism Spectrum Disorder
1,696 Patients Enrolled for Autism Spectrum Disorder
The Marcus FoundationOTHER
16 Previous Clinical Trials
1,511 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
172 Patients Enrolled for Autism Spectrum Disorder
PerkinElmer, Inc.Industry Sponsor
2 Previous Clinical Trials
5,443 Total Patients Enrolled
~2 spots leftby Aug 2025
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