Using VSF1.01 to reduce trauma during cochlear implant surgery

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.

This study is testing if a new treatment called VSF1.01 can help reduce trauma during cochlear implant surgery for people with profound hearing loss.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 11 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hannover Medical School (other)
• Locations: 1 site (Hanover)
• Trial ID: NCT06545175 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety of applying VSF1.01 directly into the cochlea during cochlear implant surgery for patients with profound hearing loss. The study aims to determine if this application can minimize surgery-related trauma and improve neural responses, speech understanding, hearing thresholds, and electrode impedances. Participants will receive the treatment during their cochlear implant operation, which will follow standard clinical procedures. The trial includes both Phase 1 and Phase 2 assessments to ensure thorough evaluation of safety and effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with profound hearing loss, with or without non-functional residual hearing.

Not a fit: Patients with functional hearing or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to safer cochlear implant surgeries and improved hearing outcomes for patients.

How similar studies have performed: While similar approaches have been explored, this specific application of VSF1.01 is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Men, women, inter/diverse aged ≥ 18 years

  * Women without childbearing potential defined as follows:

    * at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
    * hysterectomy or uterine agenesis or
    * ≥ 50 years and in postmenopausal state \> 1 year or
  * Women of childbearing potential:

    * who are practicing sexual abstinence (periodic abstinence and withdrawal are not acceptable) or
    * who have sexual relationships with female partners only and/or with sterile male partners or
    * who are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception from the time of screening until end of the clinical trial.
* Signed written informed consent from subjects capable of understanding all information and to give full informed consent
* Functional deaf patients (profound hearing loss with or without non-functional residual hearing in the low frequencies i.e. 125 Hz: 45 dB - 95 dB; 250 Hz: 50 dB - 105 dB; 500 Hz: 55 dB - 110 dB; 750 Hz and higher: 65 dB or below) that are candidates for cochlear implantation

Exclusion Criteria:

* Patients with prior ear surgery
* Patients with inner ear malformations
* Patients with acute or chronic otitis media
* Patients with keloid disorder
* Comorbidities concerning the central nervous system
* Malignancies of any type
* Kidney disease with elevated blood values: creatinine \>1.5x above upper limit of normal (ULN), eGFR or creatinine clearance 59 mL/min/1.73 m2 (grade ≥2, CTCAE v5.0)
* Liver disease with elevated blood values: bilirubin \>1.5x ULN, AST/ALT \>3.0x ULN, ALP and y-GT \>2.5x ULN, LDH \>ULN, international normalized ratio (INR) \>1.5-2.5x baseline if on anticoagulation, albumin \<3 g/dL (grade ≥2, CTCAE v5.0)
* Suspected or verified pregnancy or breastfeeding
* Hypersensitivity to any of the components of the medications used (such as Ringer's Lactate (excipient); any residuals from cell culture or raw materials used for pharmaceutical upstream and downstream processing to generate VSF1.01 (i.e. alpha-Modified Eagle Medium (αMEM), Dulbecco's MEM (DMEM), pooled human platelet lysate (pHPL), human serum albumin (HSA), Dipeptiven, phosphate buffered saline (PBS), animal origin free recombinant enzyme (TrypLETM Select))
* Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)

Where this trial is running

Hanover

• Hannover Medical School, Dept. of Otorhinolaryngology — Hanover, Germany (RECRUITING)

Study contacts

• Principal investigator: Nils K. Prenzler, PD DR. — Hannover Medical School
• Study coordinator: Nils K. Prenzler, PD Dr.

Conditions: Hearing Loss