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

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

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

Brief Summary:

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.

Detailed Summary:

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.


Sponsor: James E.Baumgartner, MD

Current Primary Outcome: Physiologic Outcome [ Time Frame: One year ]

Age appropriate physiologic outcome measures will be recorded pre-treatment, and one year following hUCB treatment


Original Primary Outcome: Same as current

Current Secondary Outcome: Functional Outcome [ Time Frame: one year ]

Age appropriate Speech-Language assessments will be performed pre-treatment and one year post-treatment.


Original Secondary Outcome: Functional Outcome [ Time Frame: one year ]

Age approriate Speech-Language assessments will be performed pre-treatment and one year post-treatment.


Information By: Memorial Hermann Health System

Dates:
Date Received: April 25, 2011
Date Started: April 2011
Date Completion: April 2016
Last Updated: January 21, 2014
Last Verified: January 2014