J Audiol Otol.  2018 Oct;22(4):209-222. 10.7874/jao.2018.00115.

Safety of Autologous Umbilical Cord Blood Therapy for Acquired Sensorineural Hearing Loss in Children

Affiliations
  • 1Little HEARoes & Clarke Schools for Hearing and Speech, Orlando, FL, USA.
  • 2Department of Audiology and Speech-Language Pathology, University of North Texas, Denton, TA, USA.
  • 3Florida Hospital for Children, Orlando, FL, USA. Jim4423@icloud.com
  • 4Florida Radiology Institute, Orlando, FL, USA.
  • 5Little HEARoes, LLC, Winston Salem, NC, USA.
  • 6Department of Biostatistics, School of Public Health, University of North Texas, Fort Worth, TA, USA.
  • 7Florida Hospital Celebration, Celebration, FL, USA.
  • 8Shriner's Hospital for Children, Houston, TA, USA.
  • 9Department of Neurosurgery, University of Central Florida College of Medicine, Orlando, FL, USA.

Abstract

BACKGROUND AND OBJECTIVES
Sensorineural hearing loss (SNHL) in children is associated with neurocognitive morbidity. The cause of SNHL is a loss of hair cells in the organ of Corti. There are currently no reparative treatments for SNHL. Numerous studies suggest that cord blood mononuclear cells (human umbilical cord blood, hUCB) allow at least partial restoration of SNHL by enabling repair of a damaged organ of Corti. Our objective is to determine if hUCB is a safe treatment for moderate to severe acquired SNHL in children.
SUBJECTS AND METHODS
Eleven children aged 6 months to 6 years with moderate to severe acquired SNHL were treated with intravenous autologous hUCB. The cell dose ranged from 8 to 30 million cells/kg body weight. Safety was assessed by measuring systemic hemodynamics during hUCB infusion. Infusion-related toxicity was evaluated by measuring neurologic, hepatic, renal and pulmonary function before and after infusion. Auditory function, auditory verbal language assessments and MRI with diffusion tensor imaging (DTI) were obtained before and after treatment.
RESULTS
All patients survived, and there were no adverse events. No infusionrelated changes in hemodynamics occurred. No infusion-related toxicity was recorded. Five subjects experienced a reduction in auditory brainstem response (ABR) thresholds. Four of those 5 subjects also experienced an improvement in cochlear nerve latencies. Comparison of MRI with DTI sequences obtained before and after treatment revealed increased fractional anisotropy in the primary auditory cortex in three of five subjects with reduced ABR thresholds. Statistically significant (p < 0.05) reductions in ABR thresholds were identified.
CONCLUSIONS
TIntravenous hUCB is feasible and safe in children with SNHL.

Keyword

Human umbilical cord blood; Mesenchymal stem cells; Mononuclear fraction; Sensorineural hearing loss; Auditory brainstem response; Otoacoustic emission; Diffusion tensor imaging; Fractional anisotropy

MeSH Terms

Anisotropy
Auditory Cortex
Body Weight
Child*
Cochlear Nerve
Diffusion Tensor Imaging
Evoked Potentials, Auditory, Brain Stem
Fetal Blood*
Hair
Hearing Loss, Sensorineural*
Hemodynamics
Humans
Magnetic Resonance Imaging
Mesenchymal Stromal Cells
Organ of Corti
Umbilical Cord*
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