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

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
• 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

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)
• 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 (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)
• 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))
• Patients with inner ear malformations
• Patients with acute or chronic otitis media
• Comorbidities concerning the central nervous system
• Suspected or verified pregnancy or breastfeeding