NCT02579369已完成1 期
A Phase 1/2 Clinical Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa
Anterogen Co., Ltd.2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2015年12月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Area of re-epithelization
研究概览
简要总结
This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Dystrophic Epidermolysis Bullosa.
详细描述
ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an new option in treating a Dystrophic Epidermolysis Bullosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 10~60
- •Diagnosed with Dystrophic Epidermolysis Bullosa based on immunofluorescence test.
- •Bullous skin lesion sized over 10 cm^2
- •Test negative for Serum β-HCG pregnancy test on screening, if the subject is fertile
- •A subject who is willing to follow the protocol and provide a informed consent on screening, given that the information with respect to the clinical trial is provided.
排除标准
- •A subject with history of epidermoid carcinoma within a year from screening.
- •A subject who requires antibiotics due to bacterial infection on skin.
- •A subject who was dosed with oral steroid, over 0.5mg/kg a day for subjects under 18, or over 20mg in 2 weeks for subjects over 18, within 30 days prior to screening.
- •A subject treated with radiotherapy or immunosuppressants, within 30 days prior to screening.
- •A subject treated with steroids locally, within 30 days prior to screening.
- •A subject with 2-times the maximum-standardized value of ALT, AST, ALP, bilirubin, total protein
- •A subject with 2-times the maximum-standardized value of BUN, Creatinine
- •A subject with Albumin below 2.0 g/dL.
- •A subject with Hemoglobin below 6 g/dL (anemic).
- •A subject with allergic response to bovine derived protein and fibrin glue.
- •A subject administered with biologic agents or cell therapy, within 30 days prior to screening.
- •A subject administered with stem cell treatment by IV or subcutaneously to the target wound, prior to the trial
- •A subject who enrolled into another clinical trial, within 30 days prior to screening
- •A subject with serious disease that can affect on clinical trial.
- •A pregnant or breast-feeding subject.
- •A subject with history of drug abuse within 1 year of clinical significance
- •A subject who cannot proceed according to the protocol.
结局指标
主要结局
Area of re-epithelization
时间窗: Follow up to 8 weeks
次要结局
- Percentage of a target wound's re-epithelialization(Every time of visit for follow up to 8 weeks)
- Time taken to re-epithelization(Over 8 weeks)
- Safety assessed by clinically measured abnormality of laboratory tests and adverse events(Over 8 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot UlcersDiabetic Foot UlcerNCT02619877Anterogen Co., Ltd.59
已完成
1 期
A Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Deep Second-degree Burn WoundBurnNCT02394873Anterogen Co., Ltd.5
已完成
3 期
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers.Diabetic Foot UlcerNCT03370874Anterogen Co., Ltd.150
已完成
3 期
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers.Diabetic Foot UlcerNCT04569409Anterogen Co., Ltd.104
已完成
不适用
A Follow-up Study to Evaluate the Efficacy and Safety of ALLO-ASC-DFU in ALLO-ASC-EB-101 Clinical TrialDystrophic Epidermolysis BullosaNCT03183934Anterogen Co., Ltd.2