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 Clarke Schools for Hearing and Speech, performed the study at the Florida Hospital for Children.
The study was published in August 2018 by the Journal of Audiology and Otology, and institutional funding was provided solely by CBR, a California Cryobank company.
As part of their commitment to help advance the science of newborn stem cells, CBR funded this phase 1 pilot study to assess the safety and preliminary efficacy of infusions of autologous umbilical cord blood in 11 children with acquired SNHL.
The study demonstrated that the cord blood infusions were safe, feasible, and well tolerated. In addition, 45% of participants showed improvements on Auditory Brainstem Response after their infusion.
SNHL is defined as hearing loss due to damage or dysfunction of the inner ear (as opposed to other structures of the ear).
This can be a result of premature birth, infections, or exposure to noise or ototoxic drugs, resulting in irreversible damage to the fragile hair cells (cilia) in the inner ear.
Although hearing aids or cochlear implants help to improve the ability to hear in individuals who have SNHL, these current interventions don't address the underlying cause. Currently, there is no cure for SNHL.
Founded in 1992, CBR is entrusted by parents with storing more than 800,000 children's cord blood and cord tissue samples. CBR is dedicated to advancing the clinical application of cord blood and cord tissue stem cells by partnering with institutions to establish FDA-regulated clinical trials for conditions that have no cure.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval