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

This study has suspended participant recruitment.
(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)
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 Orlando FL
Information provided by (Responsible Party):
James E.Baumgartner, MD, Memorial Hermann Healthcare System
ClinicalTrials.gov Identifier:
NCT01343394
First received: April 25, 2011
Last updated: January 21, 2014
Last verified: January 2014

April 25, 2011
January 21, 2014
April 2011
January 2013   (final data collection date for primary outcome measure)
Physiologic Outcome [ Time Frame: One year ] [ Designated as safety issue: No ]
Age appropriate physiologic outcome measures will be recorded pre-treatment, and one year following hUCB treatment
Same as current
Complete list of historical versions of study NCT01343394 on ClinicalTrials.gov Archive Site
Functional Outcome [ Time Frame: one year ] [ Designated as safety issue: No ]
Age appropriate Speech-Language assessments will be performed pre-treatment and one year post-treatment.
Functional Outcome [ Time Frame: one year ] [ Designated as safety issue: No ]
Age approriate Speech-Language assessments will be performed pre-treatment and one year post-treatment.
Not Provided
Not Provided
 
Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children
Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hearing Loss
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
Experimental: Biologic; Autologous Cell Injection
Intervention: Biological: Autologous Human Umbilical Cord Blood
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
10
April 2016
January 2013   (final data collection date for primary outcome measure)

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.
Both
6 Weeks to 18 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01343394
JB IND14312
Yes
James E.Baumgartner, MD, Memorial Hermann Healthcare System
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 Orlando FL
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
Memorial Hermann Health System
January 2014

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