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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss
• Intervention / Treatment: Drug: Intracochlear application of VSF1.01

• Study Type: Interventional
• Enrollment (Estimated): 11
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Nils K. Prenzler, PD Dr.; Phone Number: 9877 +49(0)511 532; Email: Prenzler.Nils@mh-hannover.de

Study Locations

• Germany
  • Hanover, Germany, 30625
    • Recruiting
    • Hannover Medical School, Dept. of Otorhinolaryngology
    • Contact: Nils K. Prenzler, PD Dr.; Phone Number: 9877 +49(0)511 532; Email: Prenzler.Nils@mh-hannover.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intracochlear treatment with VSF1.01	Drug: Intracochlear application of VSF1.01; During cochlear implant operation, patients receive intracochlear VSF1.01 prior to insertion of the electrode array.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate and severity of (serious) adverse events	Recording and documentation of number and severity of (serious) adverse events	Continuously from start to end of study [Start: IMP treatment (day 0), end of the study (Follow-up 5)], assessed up to approximately 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of eCAP growth function	Assessment of effectiveness on neural responses of auditory nerve by measuring electrically evoked compound action potential (eCAP; eCAP growth function)	Continuously from start to end of study [Start: IMP treatment (day 0), end of the study (Follow-up 5)], assessed up to approximately 6 months
Evaluation of speech perception	Assessment of effectiveness on speech understanding by measuring speech perception (in quiet and in noise) by HSM 10dB SNR/5dB SNR, FBM, OLSA 50%	From Day 1 (FU 1) to end of study (FU 5), assessed up to approximately 6 months
Measurement of air and bone conduction	Assessment of effectiveness on hearing thresholds by measuring air and bone conduction from 125 Hz - 16,000 Hz by pure tone audiometry	At Screening/baseline and from Day 1 (FU 1) to end of study (FU 5), assessed up to approximately 6 months
Measurement of impedance levels	Assessment of effectiveness on electrode impedances by determination of impedance levels (as measure to rule out pathological levels and as part of clinical routine)	From Day 0 to end of study (FU 5), assessed up to approximately 6 months

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Nils K. Prenzler, PD DR., Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss
• Other Study ID Numbers: 2024-512498-29-00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No