The Cord Blood Registry has announced the beginning of an FDA-regulated study at the Florida Hospital for Children in Orlando to investigate the potential of a child’s umbilical cord stem cells to treat acquired sensorineural hearing loss.
In the United States, about 15% of children suffer from low or high frequency hearing loss. Sensorineural hearing loss is the most common type of hearing loss, especially at high frequencies. 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. Because the ability to hear affects language development, hearing impairments can lead to poor academic and social development.
This particular study is a Phase I clinical trial, which will determine the safety and efficacy of using cord blood stem cells in children to improve inner ear function, and speech and language development.
In this study, the research group will follow 10 children who range in age from 6 weeks to 6 years, who have been diagnosed with acquired hearing loss for less than 18 months and who have had their own umbilical cord blood processed and stored.
Unfortunately, children who have a known genetic cause of deafness are ineligible for study participation. Patients will receive one intravenous infusion of their own umbilical cord blood stem cells. All patients will be tested at 1 month after the infusion, 6 months, and 1 year post-treatment.
As usual, this clinical trial is inspired by positive results in preclinical tests in laboratory animals.