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Autologous Umbilical Cord Blood Infusion for Children With Autism Spectrum Disorder (ASD)

NCT02176317 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-12-03

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Autologous Umbilical Cord Blood

All participants will receive autologous umbilical cord blood cells with a pre-cryopreservation cell dose of 1-5 x 10\^7 Total Nucleated Cells (TNC)/kilogram of subject body weight. The cells will be administered as a single intravenous (into the vein) infusion over 2 to 25 minutes

Sponsors & Collaborators

  • The Marcus Foundation

    collaborator OTHER

  • PerkinElmer, Inc.

    collaborator INDUSTRY

  • Duke University

    lead OTHER

Principal Investigators

  • Joanne Kurtzberg, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
24 Months
Max Age
72 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02176317 on ClinicalTrials.gov