NCT02038972

Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: James Baumgartner, MD · Academic / Other
• Sex: All
• Age: 6 Weeks – 6 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Sensorineural Hearing Loss

Interventions

Type	Name	Description
GENETIC	Autologous Stem Cells	The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-12-11
• Completion: 2017-01-10
• First posted: 2014-01-17
• Last updated: 2018-03-05

Locations

1 site across 1 country: United States