Umbilical Cord Blood in the Treatment of Stroke in Children.

NCT01700166 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-03-20

No results posted yet for this study

Summary

The specific aims of this study are:

1. To determine if Human Umbilical Cord Blood (hUCB) infusion is safe in children with perinatal arterial ischemic stroke (AIS).
2. To determine if late functional outcome, physiologic response, and anatomic findings are changed following hUCB infusion in children with perinatal AIS.

Conditions

  • Arterial Ischemic Stroke (AIS) in Children

Interventions

BIOLOGICAL

Autologous Human Cord Blood derived Stem Cell injection

One time intravenous (in the vein) injection with two year follow-up

Sponsors & Collaborators

  • The Institute for Rehabilitaion and Research Foundation

    collaborator OTHER
  • Cord Blood Registry, Inc.

    collaborator INDUSTRY
  • The University of Texas Health Science Center, Houston

    collaborator OTHER
  • M.D. Anderson Cancer Center - Houston

    collaborator UNKNOWN
  • Baylor College of Medicine

    collaborator OTHER
  • Aryn Knight

    lead OTHER

Principal Investigators

  • Timothy C. Foster, MD · The University of Texas Health Science Center, Houston

  • Linda S. Baumgartner, MS, CCC-SLP, LSLS, Cert.AVT · Florida Hospital for Children - Orlando

  • James E. Baumgartner, MD · Florida Hospital for Children - Orlando

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Weeks
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-08-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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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 NCT01700166 on ClinicalTrials.gov