Hearing Loss Clinical Trial

Impact of acquired sensorineural hearing loss

Sensorineural hearing loss (SNHL) is a specific type of hearing loss that involves damage to, or dysfunction of, the inner ear (as opposed to other structures of the ear). Acquired SNHL can happen as the result of premature birth, infections, or exposure to loud noise or to certain drugs, resulting in irreversible damage to the fragile hair cells (cilia) in the inner ear.105

Although there is currently no cure for SNHL, researchers are focusing on developing potential treatments and therapies that may help children impacted by acquired SNHL. Some researchers hope to build upon previous laboratory studies that demonstrated that cord blood may help restore function to hearing structures.106

The role of newborn stem cells

The role of newborn stem cells

Cord blood stem cells may have unique advantages:

  • Targeted therapy: Unlike other hearing loss treatments, early laboratory studies have shown that cord blood stem cells appear to address the underlying cause of hearing loss directly by helping to regenerate delicate structures within the inner ear.106
  • Self-repair: In laboratory studies, newborn stem cells have demonstrated the ability to home in on the site of damage. They may also have the potential to spur the repair mechanism at that site.106
  • Safe and accessible: Cord blood can be easily collected at the time of birth and stored for potential future use by the newborn donor or close family member.

Phase I clinical trial

This is the first published phase I clinical trial evaluating the use of autologous cord blood in children with acquired sensorineural hearing loss. This small pilot study provided encouraging results for a condition that currently has no cure. We are optimistic that the advances made in this area may pave the way for more research studying cord blood as a potential treatment for acquired hearing loss.

Study highlights107

  • Design: Led by co-principal investigators, Dr. James Baumgartner, MD and Pediatric Surgeon at Florida Hospital for Children, and Linda Baumgartner, Certified Auditory Verbal Therapist at Little HEARoes and the Clarke Schools for Hearing and Speech, researchers conducted a phase I, open-label trial to assess the safety and preliminary efficacy of a single intravenous infusion of autologous umbilical cord blood in children with acquired SNHL. Each of the participants received their own cord blood and were monitored at certain intervals for one year post-infusion.
  • Funding: CBR provided all institutional funding and supported the study as part of our commitment to advancing the science of newborn stem cells.
  • Participants: Eleven children were enrolled in the trial whose cord blood had been preserved with CBR at the time of birth. The children ranged in age from 6 months to 6 years.
  • Outcomes: The study provided evidence that the autologous cord blood infusions were safe, feasible, and well tolerated. Statistically significant improvements were identified, and results suggested that autologous (self) infusion of cord blood may have the potential to promote healing in the inner ear structures and improve hearing. Five of the 11 children who participated experienced an improved ability to detect sounds.

We find these results exciting because acquired SNHL is permanent and not expected to improve with other therapies (like speech therapy), or with age. While this was a small study and additional research is needed, it is encouraging that there could be more options in the future for children with acquired SNHL, and there is potential to further the research for other types of hearing loss.

“A child’s hearing ability affects the development of language skills and future academic and social development. This is why it is crucial that hearing impairment needs to be identified and addressed as early in life as possible.”
– Dr. James Baumgartner

What's next for hearing loss research?

What's next for hearing loss research?

Researchers believe that research to restore hearing loss is a worthwhile line of scientific inquiry, but larger studies are needed to establish evidence regarding efficacy of cord blood in children with acquired SNHL. We’re excited about the outcome of this trial as it demonstrates the potential of the investment that families make when preserving newborn stem cells.

CBR keeps you connected

CBR keeps you connected

CBR is committed to keeping our clients informed about the latest research developments and clinical trial opportunities. We encourage our clients to participate in the Family Health Registry™, where we identify conditions common among CBR families, such as acquired SNHL. This helps us to learn more about the conditions and connect individuals who might be candidates for clinical trials to the researchers studying new potential applications.

  • By preserving cord blood stem cells now, families may have the opportunity to use the cells in the future.
  • All 11 children who participated are CBR clients whose cord blood had been preserved at the time of birth.
  • CBR is continuing to connect current clients to novel research, including clinical trials for conditions that have no cure today.
  • CBR invests in the future of families – we were the sole institution that provided funding for this study.
  • Already a CBR family? Speak with a Genetic Counselor