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Trial record 1 of 7 for:    hearing loss cord blood
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Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01343394
Recruitment Status : Suspended (UT-IRB insists on protocol design change -Not rel to any pt. safety/non-compliance-Recruiting halted at UT/MHHS but may resume at FLHosp for Children-OrlandoFL)
First Posted : April 28, 2011
Last Update Posted : January 23, 2014
Sponsor:
Collaborators:
Cord Blood Registry, Inc.
Speech Therapists for Children
The University of Texas Health Science Center, Houston
M.D. Anderson Cancer Center
Baylor College of Medicine
The Methodist Hospital System
Florida Hospital for Children
Information provided by (Responsible Party):
James E.Baumgartner, MD, Memorial Hermann Health System

Tracking Information
First Submitted Date  ICMJE April 25, 2011
First Posted Date  ICMJE April 28, 2011
Last Update Posted Date January 23, 2014
Study Start Date  ICMJE April 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
Physiologic Outcome [ Time Frame: One year ]
Age appropriate physiologic outcome measures will be recorded pre-treatment, and one year following hUCB treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01343394 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
Functional Outcome [ Time Frame: one year ]
Age appropriate Speech-Language assessments will be performed pre-treatment and one year post-treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
Functional Outcome [ Time Frame: one year ]
Age approriate Speech-Language assessments will be performed pre-treatment and one year post-treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children
Official Title  ICMJE Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children
Brief 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.
Detailed Description

Acquired sensorineural hearing loss is characterized by a loss of functioning hair cells in the Organ of Corti, with greater hair cell loss correlating with more severe hearing impairment. Children with sensorineural hearing loss experience difficulty developing normal language which usually leads to poor academic and social development. Currently, there are no reparative therapeutic options available, and treatments are designed to augment the diminished function of the injured Organ of Corti.

Pre-clinical data suggest progenitor cell infusions may enhance intrinsic repair mechanisms in the Organ of Corti which may restore hair cells. This treatment could ultimately lead to hearing improvement. Human umbilical cord blood (hUCB) is an available, autologous, stored progenitor cell population available for potential therapeutic use. The primary objective of this study is to determine the safety of autologous hUCB infusion in children with acquired hearing loss. The secondary objective is to determine if functional, physiologic and anatomic outcomes are improved following hUCB treatment in this patient population.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hearing Loss
Intervention  ICMJE Biological: Autologous Human Umbilical Cord Blood
6 million cells/kg will be administered intravenously at one treatment time point.
Other Names:
  • Autologous Human Umbilical Cord Blood Mononuclear Fraction Cells
  • Patient's Own Stem Cells
Study Arms  ICMJE Experimental: Biologic; Autologous Cell Injection
Intervention: Biological: Autologous Human Umbilical Cord Blood
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: April 27, 2011)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2016
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Evidence of a moderate to profound sensorineural hearing loss.
  2. Normally shaped cochlea, as determined by MRI.
  3. The loss must be considered acquired, NOT syndromic.
  4. The patient must be fitted for hearing aids of the detection of the loss.
  5. Enrollment in a parent/child intervention program.
  6. Between 6 weeks and 18 months of age at the time of cord blood infusion.
  7. Ability of child and caregiver to travel to Houston for treatment and all follow-up appointments. (Patient's family is responsible for the cost of travel to and lodging in Houston).

Exclusion Criteria:

  1. Inability to obtain pertinent medical records.
  2. Known history or

    • Recently treated ear or other infection.
    • Renal disease.
    • Hepatic disease.
    • Malignancy.
    • HIV.
    • Immunosuppression (WBC < 3,000).
    • Evidence of an extensive stroke (> 100ml).
    • Pneumonia, or chronic lung disease.
  3. hUCB sample contamination.
  4. Participation in a concurrent intervention study.
  5. Desire for organ donation in the event of death.
  6. Unwillingness or inability to stay 4 days following hUCB infusion, and to return for the one month, six month and one year follow-up visits.
  7. Presence of a cochlear implant device.
  8. Evidence of a syndrome.
  9. Positive test for genetic hearing loss.
  10. Evidence of conductive hearing loss.
  11. Documented evidence of recurrent middle ear infections (> 5/year).
  12. Otitis media at the time of examination.
  13. Mild sensorineural hearing loss.
  14. Over 18 months at the time of infusion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Weeks to 18 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01343394
Other Study ID Numbers  ICMJE JB IND14312
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James E.Baumgartner, MD, Memorial Hermann Health System
Study Sponsor  ICMJE James E.Baumgartner, MD
Collaborators  ICMJE
  • Cord Blood Registry, Inc.
  • Speech Therapists for Children
  • The University of Texas Health Science Center, Houston
  • M.D. Anderson Cancer Center
  • Baylor College of Medicine
  • The Methodist Hospital System
  • Florida Hospital for Children
Investigators  ICMJE
Principal Investigator: James E. Baumgartner, MD MHHS, Houston,TX & FL Hospital for Children, Orlando, FL
Principal Investigator: Linda S. Baumgartner, CCC-SLP, LSLS CERT.AVT Speech Therapists for Children
Principal Investigator: Samir Fakhri, MD The University of Texas Health Science Center, Houston
PRS Account Memorial Hermann Health System
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP