CTIS2023-507717-94-00进行中（未招募）1 期
A multicentre, intra-patient randomised controlled Phase III study to confirm the efficacy and safety of denovoSkin™, a bilayer engineered collagen-based skin graft composed of autologous fibroblasts and keratinocytes, for the treatment of patients with deep partial and full-thickness burns - dS-BA-PIII
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Cutiss AG
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 65+（—）
- 性别
- All
入选标准
- •Patients with deep partial or full-thickness thermal burns of =20% TBSA for which excision and SOC (STSG) are clinically indicated, Patients of either sex aged =12 years, Signed informed consent from the patient and/or legally authorised representative
排除标准
- •Burn wound areas solely located on the head and neck (i.e., test and control areas must NOT be located on head/neck), Women of child-bearing potential not using highly effective method(s) of birth control (i.e., with low failure rate <1% per year) throughout the study and/or unwilling to be tested for pregnancy. A negative serum beta-human chorionic gonadotropin (ß-hCG) test is required on the day of grafting, Patient is the Investigator, one of his/her family members, employees, and other dependent persons, Patients with serologic evidence of active hepatitis B virus infection (i.e., positive for Hepatitis B surface antigen or immunoglobulin M total Hepatitis B core antibody), active hepatitis C infection (hepatitis C virus antibody positive),positive human immunodeficiency virus serology, or positive Treponema pallidum serology, Patients with known underlying or concomitant medical conditions that, in the opinion of the Investigator, has the potential to significantly delay wound healing, e.g., glycated haemoglobin (HbA1c) =53 mmol/mol and/or systemic skin and connective tissue diseases, Patients with pre-existing coagulation disorders as defined by international normalised ratio outside its normal value, a prothrombin time greater than the upper limit of normal, and fibrinogen less than the lower limit of normal prior to the current hospital admission, Patients with a history of clinically significant hypersensitivity to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen, Previous treatment with denovoSkin™, Participation in any clinical interventional study within 60 days prior to the first IMP administration in case of monoclonal antibodies and <30 days for all other IMPs, Patients unwilling or unable to comply with procedures required in this clinical study protocol, Pregnant or lactating women
研究者
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