Study on VSF1.01 for Reducing Surgery Trauma in Hearing Loss Patients Receiving Cochlear Implants

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for people with hearing loss who are undergoing cochlear implant surgery. The treatment being tested is called VSF1.01, which is a solution for injection derived from the conditioned medium of adult human umbilical cord-derived mesenchymal stromal cells. The purpose of the study is to evaluate the safety of injecting VSF1.01 directly into the cochlea, which is the part of the inner ear involved in hearing, during the cochlear implant procedure.

Participants in the study will receive an injection of VSF1.01 during their cochlear implant surgery. The study will monitor the safety of this treatment by recording any adverse events, which are unexpected medical problems that may occur during the study. The study will also assess the health of the auditory nerve, which is responsible for transmitting sound signals to the brain, and evaluate speech perception in both quiet and noisy environments. Additionally, hearing thresholds will be measured using a method called pure tone audiometry, and the impedance levels of the electrode contacts will be checked to ensure they are functioning properly.

This study aims to provide valuable information about the safety of using VSF1.01 as an additional treatment during cochlear implant surgery. The findings could potentially lead to improved outcomes for individuals with hearing loss who are candidates for cochlear implants. The study is expected to continue until June 2026, with recruitment starting in September 2024.

1 joining the study

Upon joining the study, you will be required to provide a signed written informed consent. This confirms your understanding of the study and your agreement to participate.

You must meet specific criteria, such as being 18 years or older and having profound hearing loss, to be eligible for the study.

2 initial evaluation

A clinical evaluation will be conducted to assess your current health status and hearing condition. This includes measuring your hearing thresholds using pure tone audiometry, which tests your ability to hear different frequencies.

Your auditory nerve health will be evaluated through a test called electrically evoked compound action potential (eCAP).

3 surgery and medication administration

You will undergo cochlear implant surgery. During this procedure, a solution called VSF1.01 will be injected directly into your cochlea. This is done to help reduce trauma related to the surgery.

The injection is a one-time procedure performed during the surgery.

4 post-surgery evaluation

After the surgery, your recovery and the effects of the injection will be closely monitored. This includes regular check-ups to document any adverse events and to ensure your safety.

Your speech perception will be tested in both quiet and noisy environments using specific tests designed to measure how well you understand speech.

5 follow-up assessments

Impedance levels of the electrode contacts in your cochlear implant will be measured to ensure they are functioning correctly. This helps identify any potential issues such as ossification or fibrosis.

These assessments are part of the routine follow-up after cochlear implantation and will continue until the end of the study.

Who Can Join the Study?

Men, women, and individuals of diverse gender identities who are 18 years or older.
Women who cannot have children due to:
- Having had surgery to prevent pregnancy, such as removal of ovaries or fallopian tubes.
- Having had a hysterectomy (removal of the uterus) or being born without a uterus.
- Being 50 years or older and having gone through menopause for more than a year.
Women who can have children must:
- Practice sexual abstinence (not having sex) or have sex only with female partners or sterile male partners.
- If sexually active with a fertile male partner, have a negative pregnancy test during screening and agree to use reliable birth control methods until the end of the study. Acceptable methods include:
  - Combined hormonal birth control (pills, patches, or rings) that stop ovulation.
  - Progestogen-only hormonal birth control (pills, injections, implants) that stop ovulation.
  - Intrauterine device (IUD).
  - Intrauterine hormone-releasing system (IUS).
Must provide signed written consent, showing they understand the study and agree to participate.
Must have profound hearing loss (very severe hearing loss) and be a candidate for a cochlear implant. This includes those with or without some remaining hearing at low frequencies (measured in Hertz, Hz).

Who Cannot Join the Study?

Patients who do not have hearing loss cannot participate.
Patients who are not in the age range of 3 to 4 years old cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people with certain disabilities who might need special protection in research.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.09.2024

Trial locations

Investigated drugs:

Vsf1.01

VSF1.01 is a special treatment being tested in this clinical trial. It is a mixture that contains tiny particles called extracellular vesicles, which are taken from human umbilical cord stem cells. These particles are thought to help reduce damage during cochlear implant surgery. The goal of using VSF1.01 is to make the surgery safer by protecting the delicate structures inside the ear. This treatment is given directly into the cochlea, which is the part of the ear that helps with hearing. The study is focused on making sure that this treatment is safe for patients who are getting cochlear implants.

Hearing Loss – Hearing loss is a condition where an individual experiences a reduced ability to hear sounds. It can occur in one or both ears and can be temporary or permanent. The progression of hearing loss can vary; it may happen suddenly or gradually over time. Causes include damage to the inner ear, buildup of earwax, infections, or exposure to loud noise. As the condition progresses, individuals may find it increasingly difficult to understand speech, especially in noisy environments. Hearing loss can affect people of all ages and may lead to social withdrawal and communication difficulties.

Trial ID:

2024-512498-29-00

Protocol code:

ESCRT

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on VSF1.01 for Reducing Surgery Trauma in Hearing Loss Patients Receiving Cochlear Implants

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