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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 5 years
Awards & highlights
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,454 Previous Clinical Trials
2,971,586 Total Patients Enrolled
14 Trials studying Autism Spectrum Disorder
2,296 Patients Enrolled for Autism Spectrum Disorder
The Marcus FoundationOTHER
16 Previous Clinical Trials
1,508 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
169 Patients Enrolled for Autism Spectrum Disorder
PerkinElmer, Inc.Industry Sponsor
2 Previous Clinical Trials
5,443 Total Patients Enrolled
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