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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
Florida Hospital
Orlando, Florida, United States
Safety of Autologous Stem Cell Infusion: Number of Participants With Adverse Events.
To determine if autologous human umbilical cord blood (hUBC) infusion in children with hearing loss is safe.
Time frame: 1 year
Feasibility of Autologous Stem Cell Infusion: Number of Participants Who Completed Cord Blood Infusion and 1 Month Follow-up.
To determine if autologous human umbilical cord blood (hUBC) infusion in children with hearing loss is feasible.
Time frame: 1 month
Change in Auditory Brainstem Response (ABR) Threshold in Decibels.
ABR Threshold is a measure of the sound necessary to activate transmission through the eighth cranial nerve. Each participant was evaluated before, 1,6 and 12 months after autologous stem cell treatments. For each ear, ABR threshold was measured at 500, 1000, 2000 and 4000 Hz and using "Click" ABR.
Time frame: Pre-treatment (Baseline), 1,6 & 12 months post-treatment
Change in Eight Cranial Nerve Wave 5 Latencies in Miliseconds.
.For each ear, latency was measured at 500, 1000, 2000 and 4000 Hz and using "Click" ABR.
Time frame: Pre-treatment (Baseline), 1,6 & 12 months post-treatment
Change in Standard Language Scores.
Preschool Language Scale-5. This test measures language development in infants and children. Standard scores are derived, with a mean of 100 and a standard deviation of 15, to compare a child's performance to their peers. Higher values are associated with better language development.
Time frame: Pre-treatment, 6 & 12 months post-treatment
Change Fractional Anisotropy in the White Sites Along the Audiotory Pathways
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Fractional anisotropy are arbitrary values generated from the DTI sequences of an MRI scan. Higher values suggest increased integrity of white matter pathways. Responders and nonresponders were evaluated separately. (Define non-responders and responders).Although 11 subjects were enrolled and received an autologous cord blood infusion, three subjects did not complete the entire MRI study protocol and could not be analyzed at study completion. The reasons these subjects did not undergo the second MRI are as follows: Subject 7 dropped out of the study, and Subject 11 underwent bilateral cochlear implantation after the 1-month follow-up. Subject 10 refused testing at 12-month follow-up.
Time frame: Pre-treatment & 12 months post-treatment