in vivo studies

Uniquely specialized in the field of hearing disorders and associated diseases, Cilcare provides a comprehensive range of in vivo studies for preclinical research with a strong translational focus. Our dedicated efforts in this field are geared towards driving innovation and progress in the diagnosis and treatment of hearing-related conditions.

auditory efficacy studies

Cilcare has established a range of robust, validated, and translational animal models meticulously designed to replicate the primary causes of hearing loss. They provide crucial relevance to evaluate the efficacy of drug candidates, cell and gene therapies, or devices aimed at preventing or treating hearing loss. Cilcare’s models are invaluable for assessing otoprotection strategies and regeneration processes in the pursuit of auditory restoration.

Learn more about our animal models

auditory tolerance & safety studies

Clinical data confirms that many therapeutic compounds, including those targeting indications unrelated to hearing and otic disorders, should be tested for auditory safety. Ototoxicity and associated auditory pathologies may affect millions of patients taking medication, potentially contributing to a diminished quality of life.

Additionally, several promising therapeutics and devices are currently in development for improving the lives of more than 500 million people suffering from hearing loss or tinnitus. The auditory safety of these solutions must be tested before being approved by regulatory authorities.

CILcare provides unparalleled ototoxicity services that support early-stage development and late-stage safety assessments. We conduct preclinical trials in rodents and larger animals using functional, behavioral, and morphological read-outs. Whether you are looking to evaluate the safety of a formulation, the own effects of your drug candidates, or to compare them with an ototoxic reference compound, CILcare is able to provide you with exactly what you need to develop therapies that are safe for the inner ear.

Study evaluation includes:

  • ABR & DPOAE to assess the activity and integrity of inner hair cells & auditory nerve (ABR) and outer hair cells (DPOAE)
  • Wave I analysis to study synaptic function
  • GPIAS to assess the presence of tinnitus
  • Histopathology with hair cells & ribbon synapses count to evaluate cochlear damage

auditory phenotyping studies

Cilcare specializes in characterizing the hearing functions of your transgenic animal or specific pathological animal models, delivering robust auditory data.

From functional hearing assessments to comprehensive post-mortem samplings and histopathology assessment, we offer a complete solution to get your model phenotyped.

GLP ototoxicity studies / GLP Toxicology & Toxicokinetics

Cilcare forged a strategic alliance with the Boston-based GLP-compliant biomedical research institute CBSET, Inc. in 2017. This partnership was established with a clear mission: to provide drug and device developers with cutting-edge preclinical services for the evaluation of auditory functions in a regulated Good Laboratory Practices (GLP) environment.

Our collaboration unites the scientific expertise in auditory assessment with a strong GLP-compliant preclinical experience, resulting in a potent risk mitigation strategy for your regulatory submissions. From general toxicology studies to surgical services, our team has the capability to customize a full preclinical program in line with your IND approach and project milestones, ensuring the generation of robust and reproducible data.

CBSET’s cutting-edge research facility assets:

  • Extensive experience performing GLP-compliant research services
  • AAALAC-accredited, OLAW-assured animal research facilities
  • Board Certified Clinical Veterinarians and Veterinary Pathologists
  • Good track record with FDA inspection
  • Rodent and large species housing

 

How to evaluate auditory safety ?

FDA guidance documents specify auditory safety evaluation utilizing two methodologies*:

1/ In vivo assessment: measure of Auditory Brainstem Responses (ABR)

Auditory Brainstem Responses (ABR) are electric potentials recorded from scalp electrodes. This non-invasive method allows to determine auditory response threshold. It is translational between rodents and human and is commonly used for screening newborns.

2/ Ex vivo assessment: cytocochleogram

The cytocochleogram allows histopathological assessment of ototoxic damage on inner hair cells and outer hair cells of the cochlea, with anatomical localization corresponding to predicable patterns of functional deficits.