Hearing Loss Clinical Trial

Acquired Hearing Loss and Newborn Stem Cells

Florida Hospital for Children and Cord Blood Registry® (CBR) are launching a FDA-regulated, Phase I safety study of the use of cord blood stem cells to treat children with sensorineural hearing loss.

Approximately 15 percent of children in the U.S. suffer from low or high-frequency hearing loss. The most common type of hearing loss, especially at high frequencies, is sensorineural. Acquired sensorineural hearing loss results from damage to hair cells in the inner ear (cochlea) and can be caused by illness, medication, noise exposure, birth injury, or head trauma.

"Babies are surviving prematurity in historically high numbers today, and with this advance we are seeing more young children born with acquired hearing loss. To date, there are no treatments to repair a damaged inner ear,” said James Baumgartner, MD, Surgical Director of Florida Hospital for Children’s Comprehensive Pediatric Epilepsy Center, and the study’s principal investigator. “Although hearing aids and cochlear implants provide valuable access to sound, they do not restore the complexity of a fully functioning biological ear. Using cord blood stem cells to trigger the body’s own repair mechanisms could provide a non-invasive avenue to normal hearing."

The study will enroll 10 children between the ages of 6 weeks and 6 years old, who meet the inclusion criteria for the study. Children with genetic deafness are ineligible for study participation. To ensure consistency in cord blood stem cell quality, CBR is the only family stem cell bank providing units from clients for the study. If you would like to be contacted regarding trial participation, please sign up here.

View press release

Hearing Loss at a Glance

i Niskar, AS, et al. Prevalence of hearing loss among children 6 to 19 years of age: the Third National Health and Nutrition Examination Survey. JAMA.1998;279:1071-1075.