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

Ki vehet részt

• 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

Ki nem vehet részt

• Patients with prior ear surgery
• Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
• 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)
• Patients with keloid disorder
• 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)
• Intolerance to medical grade silicone
• Patients with acute or chronic otitis media
• Patients with inner ear malformations
• Comorbidities concerning the central nervous system
• Suspected or verified pregnancy or breastfeeding