NCT06545175进行中（未招募）1 期
Extracellular Vesicle-enriched Secretome Fraction (VSF1.01) for the Reduction of Cochlear Implant Surgery Related Trauma (ESCRT). An Open-label Monocentric Phase I/IIa Clinical Trial to Investigate the Safety of Intracochlear Application of VSF1.01 Enriched With hUC-MSC-EVs in Patients Receiving Cochlear Implantation.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Rate and severity of (serious) adverse events
研究概览
简要总结
The goal of this clinical trial is to assess the safety of intracochlear application of VSF1.01 for the reduction of cochlear implant surgery related trauma in patients with profound hearing loss with or without non-functional residual hearing in low frequencies and cochlear implantation.
The main questions it aims to answer are:
Primary objective:
Safety of intracochlear application of VSF1.01 in patients receiving cochlear implantation
Secondary objectives:
Effectiveness on
- neural responses of auditory nerve
- speech understanding
- hearing thresholds
- electrode impedances
During cochlear implant operation, patients receive as adjuvant treatment intracochlear VSF1.01 prior to insertion of the electrode array.
Cochlear implantation is conducted according to the clinical standard at the investigational site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Intracochlear treatment with VSF1.01
Experimental
干预措施: Intracochlear application of VSF1.01 (Drug)
结局指标
主要结局
Rate and severity of (serious) adverse events
时间窗: Continuously from start to end of study [Start: IMP treatment (day 0), end of the study (Follow-up 5)], assessed up to approximately 6 months
Recording and documentation of number and severity of (serious) adverse events
次要结局
- Evaluation of speech perception(From Day 1 (FU 1) to end of study (FU 5), assessed up to approximately 6 months)
- Evaluation of eCAP growth function(Continuously from start to end of study [Start: IMP treatment (day 0), end of the study (Follow-up 5)], assessed up to approximately 6 months)
- Measurement of impedance levels(From Day 0 to end of study (FU 5), assessed up to approximately 6 months)
- Measurement of air and bone conduction(At Screening/baseline and from Day 1 (FU 1) to end of study (FU 5), assessed up to approximately 6 months)
研究者
研究点 (1)
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