Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children
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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Physiologic Outcome
Age appropriate physiologic outcome measures will be recorded pre-treatment, and one year following hUCB treatment
One year
No
James E. Baumgartner, MD
Principal Investigator
Memorial Hermann Health System
United States: Food and Drug Administration
JB IND14312
NCT01343394
April 2011
April 2015
Name | Location |
---|---|
Children's Memorial Hermann Hospital | Houston, Texas 77030 |