HOUSTON—Children’s Memorial Hermann Hospital and Cord Blood Registry® (CBR) will undertake the first FDA-approved, Phase I safety study on the use of cord blood to restore hearing in babies who have sustained hearing loss post-natally.
The year-long study, which will involve 10 patients, ages 6 weeks to 18 months, will use stem cells taken from each child’s own stored umbilical cord blood. This unprecedented study follows evidence from published laboratory studies that cord blood helps repair damaged organs in the inner ear. Children who are deaf as a result of a genetic anomaly or syndrome are not eligible.
The sponsor of the study is James Baumgartner, MD, a guest research collaborator at the University of Texas Health Science Center at Houston (UTHealth) Medical School. Explaining the importance of addressing hearing loss early, he said, “Children only have 18 months to acquire language skills, and if a child does not hear well, they will not acquire the language skills to speak normally.”
Parents will be interviewed by phone to determine if their children are eligible for the study. Those who meet the criteria will be admitted to Children’s Memorial Hermann Hospital to undergo a series of blood tests, hearing and speech tests, and an MRI.
Patients selected to participate will return to the hospital to repeat all tests except the MRI at one month and one year, and all tests with an MRI at six months.
The principal investigator is Samer Fakhri, MD, a surgeon at Memorial Hermann-Texas Medical Center and associate professor and program director in the Department of Otorhinolaryngology – Head & Neck Surgery at UTHealth. Fakhri said, “Currently, the only treatment options for sensorineural hearing loss are hearing aids or cochlear implants. We hope that this study will open avenues to additional treatment options for hearing loss in children.”
Co-investigator Linda Baumgartner, MS, an auditory-verbal therapist, commented, “This study is exciting because it might offer a non-surgical option for some children with profound loss. More importantly, this is the first treatment with the potential to restore normal hearing.”