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Over the past 25 years, the utilization of stem cells derived from umbilical cord blood has revolutionized medical treatments, with over 30,000 transplants performed globally to address more than 80 diseases and disorders in both adults and children. Building on this progress, researchers at Florida Hospital for Children are now conducting an FDA-regulated clinical trial supported by Cord Blood Registry® to explore the safety and feasibility of using a child's own stem cells from umbilical cord blood as a potential treatment for sensorineural hearing loss.
The Significance of the Clinical Trial:
In the United States, approximately 15% of children experience low or high-frequency hearing loss, with sensorineural hearing loss being the most prevalent type, particularly at high frequencies. This form of acquired hearing loss results from damage to hair cells in the inner ear (cochlea) and can be triggered by various factors such as illness, medication, noise exposure, birth injury, or head trauma. Given the profound impact of hearing on language development and overall well-being, the study aims to assess the potential of cord blood stem cells in triggering the body's repair mechanisms as a non-invasive therapeutic option for acquired hearing loss.
Current Treatments and Their Limitations:
Hearing aids and cochlear implants have become standard interventions for children with acquired hearing loss, yet these devices primarily assist in amplifying sounds and do not address the underlying damage to the cochlea, cochlear nerve, or brain stem. The innovative approach in this study seeks to go beyond prosthetic aids and explore whether cord blood stem cells can facilitate the body's natural repair processes.
Preclinical Evidence and Study Objectives:
Preclinical studies have shown promising evidence that the infusion of human umbilical cord stem cells may contribute to the repair of damaged cells in the inner ear, potentially leading to improvements in hearing. The primary objectives of the clinical trial are to establish the safety of using cord blood stem cells in a specific pediatric patient population and to evaluate whether this treatment approach enhances inner ear function, speech, and language development.
Study Details:
The trial involves monitoring 10 children, aged 6 weeks to 6 years, diagnosed with acquired hearing loss for less than 18 months. These children have their own cord blood units processed and stored under Cord Blood Registry's stringent quality controls. Children with a known genetic cause of deafness are excluded from study participation. Patients will undergo a single intravenous infusion of their own umbilical cord blood stem cells, with follow-up assessments at 1 month, 6 months, and 1 year post-treatment.
Current Progress and Future Implications:
To date, three children have undergone treatment, and six more are in the enrollment process. The study aligns with a growing body of research supporting the regenerative potential of stem cells derived from cord blood, providing hope for novel treatment approaches for conditions lacking a cure today. Cord Blood Registry's collaboration with leading research institutions in FDA-regulated clinical trials signifies a commitment to advancing medical breakthroughs that could usher in a new era of treating neurological conditions in both children and adults.
Source: https://parentsguidecordblood.org/en/news/cord-blood-stem-cell-infusion-children-acquired-hearing-loss?fbclid=IwAR2uqqwwK0MotZNGIgAfOzZiKO83rWDlQF8xiGx4WNzuPGLCRYN9NXmnGNI