FDA Study of Cord Blood Stem Cells to Treat Hearing Loss
FDA-Regulated Study of Cord Blood Stem Cells
to Treat Acquired Hearing Loss Launches
From PR Newswire
SAN BRUNO, Calif., Jan. 16, 2014 /PRNewswire-USNewswire/ — Cord Blood Registry® (CBR®), the world’s largest and most experienced newborn stem cell company, announces the start of a U.S. Food and Drug (FDA)-regulated study being conducted at Florida Hospital for Children in Orlando to investigate the use of a child’s stem cells from their own stored umbilical cord blood as a treatment for acquired sensorineural hearing loss.
In the United States, approximately 15 percent of children suffer from low or high-frequency hearing loss.[i] 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. A child’s ability to hear affects the development of language skills, and hearing impairments can lead to poor academic and social development.[ii]
The groundbreaking phase 1 study has a primary objective of determining the safety of using cord blood stem cells in a select pediatric patient population while also assessing whether this approach to treatment improves inner ear function, speech, and language development. Researchers will follow 10 children, ranging in age from 6 weeks to 6 years, who have been diagnosed with acquired hearing loss for less than 18 months and who have their own cord blood unit processed and stored under CBR’s strict quality controls. Children with 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 return for follow-up at 1 month, 6 months, and 1 year post-treatment.
The trial, supported by CBR, follows promising evidence from preclinical studies suggesting that the infusion of human umbilical cord stem cells may help repair damaged cells in the inner ear in ways that could lead to hearing improvement.[iii]
“As more children survive premature birth, we are observing increasing numbers of very young children with significant acquired hearing loss, and currently there are no therapies available for reversing that damage,” says Linda Baumgartner M.S., CCC-SLP, LSLS cert. AVT, the trial’s Speech and Language Pathologist and hearing loss expert. James Baumgartner, MD, Surgical Director of Florida Hospital for Children’s Comprehensive Pediatric Epilepsy Center and the study’s principal investigator notes that “presently, the only treatment options for acquired sensorineural hearing loss are hearing aids or cochlear implants, neither of which actually repairs the damage. Read the rest of the story at http://bit.ly/1dYrxpl