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Intracochlear application of (Extracellular Vesicle-enriched Secretome Fraction; VSF1.01) for the Reduction of Cochlear Implant Surgery Related Trauma (ESCRT)
EU CTIS ID: 2024-512498-29-00
What this study is testing
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.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
- Signed written informed consent from subject 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.
You likely can't join if
- Patients with prior ear surgery
- 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).
- Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
- Intolerance to medical grade silicone
- Patients with acute or chronic otitis media
- Patients with keloid disorder
See the full eligibility criteria
Who can 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: • 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)
- Signed written informed consent from subject 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.
What rules you out
- Patients with prior ear surgery
- 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).
- Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
- Intolerance to medical grade silicone
- Patients with acute or chronic otitis media
- Patients with keloid disorder
- Patients with inner ear malformations
- 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 (according to 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) >1.5x baseline if on anticoagulation, albumin <3 g/dL (according to grade ≥2 CTCAE v5.0).
- Suspected or verified pregnancy or breastfeeding
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.