NCT06545175

Intracochlear Application of VSF1.01 for the Reduction of Cochlear Implant Surgery Related Trauma

Extracellular Vesicle-enriched Secretome Fraction (VSF1.01) for the Reduction of Cochlear Implant Surgery Related Trauma (ESCRT). An Open-label Monocentric Phase I/IIa Clinical Trial to Investigate the Safety of Intracochlear Application of VSF1.01 Enriched With hUC-MSC-EVs in Patients Receiving Cochlear Implantation.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (estimated)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the safety of intracochlear application of VSF1.01 for the reduction of cochlear implant surgery related trauma in patients with profound hearing loss with or without non-functional residual hearing in low frequencies and cochlear implantation. The main questions it aims to answer are: Primary objective: Safety of intracochlear application of VSF1.01 in patients receiving cochlear implantation Secondary objectives: Effectiveness on 1. neural responses of auditory nerve 2. speech understanding 3. hearing thresholds 4. electrode impedances During cochlear implant operation, patients receive as adjuvant treatment intracochlear VSF1.01 prior to insertion of the electrode array. Cochlear implantation is conducted according to the clinical standard at the investigational site.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DRUG	Intracochlear application of VSF1.01	During cochlear implant operation, patients receive intracochlear VSF1.01 prior to insertion of the electrode array.

Timeline

• Start date: 2024-11-18
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-08-09
• Last updated: 2026-02-12

Locations

1 site across 1 country: Germany