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To determine if autologous human umbilical cord blood infusion in children with acquired hearing loss is safe, feasible, improves inner ear function, audition and language development.
Full description
There is currently no treatment available to repair/reverse acquired sensorineural hearing loss. Recent experiments using human umbilical cord blood treatment of a mouse and guinea pig models have demonstrated hair cell re-growth following acquired sensorineural loss as well as partial restoration of ABR. Autologous human umbilical cord blood therapy, which has been used for over twenty years, has an excellent safety record. This study will determine if autologous human umbilical cord blood infusion in children with hearing loss is safe and feasible, improves inner ear function, audition, and language development. The patients umbilical cord stem cells collected at birth and stored at Cord Blood Registry will be used for infusion.
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Inclusion and exclusion criteria
Inclusion Criteria:
Evidence of a sensorineural hearing loss
Normally shaped cochlea, as determined by MRI
The loss must be considered:
Fitted for hearing aids no later than six months post detection of loss.
Enrollment in a parent/child intervention program
Age 6 weeks - 6 years old at time of infusion with less than 18 months of hearing loss at the time of cord blood infusion.
Ability of the child and caregiver to travel to Orlando, and stay for at least 4 days, and to return for all follow-up visits.
Exclusion Criteria
Inability to obtain all pertinent medical records:
Known history of:
hUBC sample contamination
Banked cord cells totaling less than 6x106 mononuclear cells/kilogram body weight.
Evidence of the following maternal infections during the pregnancy (Hepatitis A, Hepatitis B, Hepatitis C, HIV 1, HIV 2, Human T-lymphotropic Virus (HTLV) 1, HTLV 2 (CMV and Syphilis can be included in the study)
participation in a concurrent intervention study
Unwillingness or inability to stay for 4 days following hUBC infusion (should problems arise following the infusion) and to return for the one month, six month and one year follow-up visits.
Presence of a cochlear implantation device
Evidence of a genetic syndrome
Evidence of conductive hearing loss
Documented recurrent middle ear infections which are frequent (>5 per year)
Otitis media at the time of examination
Sensorineural loss is mild
Over 18 months from identification of hearing loss at time of infusion
Primary purpose
Allocation
Interventional model
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11 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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