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Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children

NCT01343394 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-03-20

No results posted yet for this study

Summary

The objectives of this study are:

1. To see if autologous human umbilical cord blood treatment is safe for children with acquired hearing loss, and
2. To determine if late functional outcome is improved following autologous human umbilical cord blood treatment for children with acquired hearing loss.

Conditions

Interventions

BIOLOGICAL

Autologous Human Umbilical Cord Blood

6 million cells/kg will be administered intravenously at one treatment time point.

Sponsors & Collaborators

  • Cord Blood Registry, Inc.

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Baylor College of Medicine

    collaborator OTHER

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Florida Hospital for Children

    collaborator OTHER

  • Aryn Knight

    lead OTHER

Principal Investigators

  • James E. Baumgartner, MD · MHHS, Houston,TX & FL Hospital for Children, Orlando, FL

  • Linda S. Baumgartner, CCC-SLP, LSLS CERT.AVT · Speech Therapists for Children

  • Samir Fakhri, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Weeks
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-01-31
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01343394 on ClinicalTrials.gov