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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
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hearing Loss Biological: Autologous Human Umbilical Cord Blood Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children
Study Start Date : April 2011
Primary Completion Date : January 2013
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Biologic; Autologous Cell Injection 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

Outcome Measures

Primary Outcome Measures :
  1. Physiologic Outcome [ Time Frame: One year ]
    Age appropriate physiologic outcome measures will be recorded pre-treatment, and one year following hUCB treatment

Secondary Outcome Measures :
  1. Functional Outcome [ Time Frame: one year ]
    Age appropriate Speech-Language assessments will be performed pre-treatment and one year post-treatment.

Eligibility Criteria

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Ages Eligible for Study:   6 Weeks to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343394

United States, Texas
Children's Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
James E.Baumgartner, MD
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
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
More Information

Responsible Party: James E.Baumgartner, MD, Board-certified Pediatric Neurosurgeon, Memorial Hermann Healthcare System
ClinicalTrials.gov Identifier: NCT01343394     History of Changes
Other Study ID Numbers: JB IND14312
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: January 2014

Keywords provided by James E.Baumgartner, MD, Memorial Hermann Healthcare System:
Stem Cells
Hearing Loss

Additional relevant MeSH terms:
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms