Intracochlear application of (Extracellular Vesicle-enriched Secretome Fraction; VSF1.01) for the Reduction of Cochlear Implant Surgery Related Trauma (ESCRT)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medizinische Hochschule Hannover

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Otorhinolaryngologic Diseases [C09]

Trial duration

24 Sep 2025 → ongoing

Decision date (initial)

2024-10-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Paracelsus Medical University Salzburg

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

The primary objective of this phase I/IIa clinical study is to evaluate the safety of intracochlear injection of VSF1.01 as adjuvant in patients receiving cochlear implantation.

Secondary objectives 4

1. testing for the health of auditory nerve
2. testing for the assessment of speech understanding
3. testing for hearing thresholds
4. testing for electrode impedances in order to conclude about the effectiveness of VSF1.01 as adjuvant treatment

Conditions and MedDRA coding

hearing loss

Regulatory references

Scientific advice from competent authorities

Paul-Ehrlich-Institut

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 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. **The following methods of contraception are acceptable (failure rate of < 1% per year/highly effective): - combined (estrogen and progesterone containing) hormonal contraception (oral/intravaginal/transdermal) associated with inhibition of ovulation, - progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, - intrauterine device (IUD), - intrauterine hormone-releasing system (IUS)
2. Signed written informed consent from subject capable of understanding all information and to give full informed consent
3. 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 12

1. Patients with prior ear surgery
2. Patients with acute or chronic otitis media
3. Patients with keloid disorder
4. Patients with inner ear malformations
5. Comorbidities concerning the central nervous system
6. Malignancies of any type
7. 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 (according to grade ≥2 CTCAE v5.0).
8. 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) >1.5x baseline if on anticoagulation, albumin <3 g/dL (according to grade ≥2 CTCAE v5.0).
9. Suspected or verified pregnancy or breastfeeding
10. 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).
11. Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
12. Intolerance to medical grade silicone

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. In order to assess safety of patients, a clinical evaluation of each patient is performed. Number and severity of adverse events (AEs/SAEs) will be recorded and documented and represent the primary endpoints of the ESCRT study to create a safety profile

Secondary endpoints 4

1. Ad 1) the measurement of electrically evoked compound action potential (eCAP; eCAP growth function) in order to evaluate health of the auditory nerve
2. Ad 2) Speech perception in quiet and in noise will be evaluated by use of the Freiburg monosyllable test (FBM), the Hochmair-Schulz-Moser sentence test (HSM; at a signal to noise ratio (SNR) of 10 dB and a SNR of 5 dB) and the Oldenburger sentence test (OLSA, measuring the SNR that allows 50% speech intelligibility).
3. Ad 3) Air and bone conduction from 125 Hz – 16,000 Hz will be measured by pure tone audiometry to assess the hearing thresholds.
4. Ad 4) Impedance levels of the electrode contacts are determined and are a measure to rule out pathological levels of impedances (which can be an indication for ossification, intensive fibrosis formation, or failure of electrodes). This is part of the clinical routine investigation after cochlear implantation.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medizinische Hochschule Hannover

Sponsor organisation

Medizinische Hochschule Hannover

Address

Carl-Neuberg-Strasse 1, Gross Buchholz Gross Buchholz

City

Hanover

Postcode

30625

Country

Germany

Scientific contact point

Organisation

Medizinische Hochschule Hannover

Contact name

Department of Otorhinolaryngology

Public contact point

Organisation

Medizinische Hochschule Hannover

Contact name

Department of Otorhinolaryngology

Third parties 2

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications