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Hearing LossPhase 1/2ESCRTNCT06545175

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

A Phase 1/2 study testing Intracochlear application of VSF1.01 in people with Hearing Loss, run by Hannover Medical School at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hearing Loss
What is being tested?
Intracochlear application of VSF1.01
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteGermany
Study dates
18 Nov 2024to 28 Oct 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Hannover Medical School, Dept. of Otorhinolaryngology

    Hanover, 30625

Other trials in Germany

About this study

Official title: 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:

Read more

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
Being tested
Intracochlear application of VSF1.01
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intracochlear application of VSF1.01Drug

    During cochlear implant operation, patients receive intracochlear VSF1.01 prior to insertion of the electrode array.

Study groups in NCT06545175
Study groupRoleWhat they receive
Intracochlear treatment with VSF1.01ExperimentalNot described
Receives: Drug: Intracochlear application of VSF1.01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate and severity of (serious) adverse events

    Recording and documentation of number and severity of (serious) adverse events

    Measured: 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 outcomes (4)

  1. 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)

    Measured: 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

  2. 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%

    Measured: From Day 1 (FU 1) to end of study (FU 5), assessed up to approximately 6 months

  3. 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

    Measured: At Screening/baseline and from Day 1 (FU 1) to end of study (FU 5), assessed up to approximately 6 months

  4. 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)

    Measured: From Day 0 to end of study (FU 5), assessed up to approximately 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start18 Nov 2024
  3. Primary completion28 Oct 2026 (estimated)
  4. Study completion28 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06545175
Sponsor's protocol ID
2024-512498-29-00
Acronym
ESCRT
Status last verified
Jul 2026
First submitted
16 Jul 2024
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Intracochlear application of VSF1.01 in people with Hearing Loss, run by Hannover Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate and severity of (serious) adverse events (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06545175.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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