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First FDA-Approved Stem Cell Trial to Treat Hearing Loss Begins



A new stem cell study may offer hope for patients suffering from one of the most common causes of childhood deafness.

Sensorineural hearing loss (SNHL) occurs when there is damage to the cochlea or the nerve pathways from the inner ear to the brain. The American Speech-Language Hearing Association says the causes of SNHL can range from genetics and head trauma to drugs, illnesses and more. While most SNHL in children is congenital or acquired after birth, it may present at any age, according to the Website

Until recently, SNHL was generally considered a permanent condition. But a new stem cell trial, which launched in January in the United States, could change that thinking.

Children's Memorial Hermann Hospital in Houston, Texas, and the privately owned stem cell bank Cord Blood Registry® (CBR), San Bruno, California, are collaborating on this first FDA-approved, Phase I safety study on the use of cord blood stem cells to treat children with SNHL. The yearlong trial is led by Samer Fakhri, MD, an internationally recognized rhinologist who is currently an associate professor and residency program director at The University of Texas Medical School at Houston.

The researchers are following 10 children, aged 6 weeks to 18 months old, who have sustained post-birth SNHL. Children who are deaf as a result of a genetic anomaly or syndrome are not eligible.

The patients are treated using stem cells from their own stored umbilical cord blood. "Currently, the only treatment options for sensorineural hearing loss are hearing aids or cochlear implants," Dr. Fakhri said. "We hope that this study will open avenues to additional treatment options for hearing loss in children."

"This study is exciting because it might offer a non-surgical option for some children with profound loss," said co-investigator and auditory-verbal therapist Linda Baumgartner. "More importantly, this is the first treatment with the potential to restore normal hearing."

The study is supported by CBR and The Institute for Rehabilitation and Research (TIRR) Foundation, a nonprofit organization focused on improving the lives of people who have sustained central nervous system damage through injury or disease.

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