Clinical Research Directory

Inclusion Criteria: * 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 Exclusion Criteria: * Patients with prior ear surgery * Patients with inner ear malformations * Patients with acute or chronic otitis media * Patients with keloid disorder * 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 (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) * Suspected or verified pregnancy or breastfeeding * 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)) * Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)