NCT04612465进行中（未招募）3 期
Phase 3 Clinical Study to Evaluate Efficacy and Safety of ASC(Autologous Adipose-derived Stem Cells) and Fibringlue or Fibringlue in Patients With Crohn's Fistula.: A Randomized Study
Anterogen Co., Ltd.4 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年1月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Proportion of subjects who are completely blocked fistula
研究概览
简要总结
This is a phase III study to evaluate the efficacy and safety of ASC(Autologous Adipose-derived Stem Cells) and Fibringlue or Fibringlue in Patients With Crohn's Fistula.
详细描述
Experimental: ASC(Autologous Adipose-derived Stem Cells) and Fibringlue, Comparator: Fibringlue, Study type: Interventional, Study design: Randomized
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patient who has obtained the consent of their legal representative if they are over 18 years of age and under 20 years of age.
- •Patient is diagnosed with Crohn's disease.
- •Patient who has one or more Crohn's fistulas .
- •In the case of women of childbearing potential, patient who is negative for beta-HCG pregnancy tests at the screening visit.
- •Patient is able to give written informed consent prior to study start and willing to comply with the study requirements.
排除标准
- •Patient who participated in other clinical trials within 30 days prior to the start of this clinical trial, or who has not passed a period equal to five times of the half-life of the drug dosed in other clinical trials.
- •Patient with a medical history or family history of Variant Creutzfeld Jakob Disease or related to this disease.
- •Patient who is sensitive to anesthetic drugs or bovine-derived materials.
- •Patient with autoimmune disease except for Crohn's disease.
- •Patient with infectious diseases such as HBV, HCV and HIV.
- •Patient with signs of Septicemia.
- •Patient with Active Tuberculosis.(Including patient with Anal Tuberculosis)
- •Pregnant or breast-feeding.
- •. Is unwilling to use an acceptable method of birth control during the whole study.
- •Patient with Inflammatory Bowel disease except for Crohn's disease.
- •Patient who is sensitive to Fibringlue.
- •Patient with a clinically relevant history of alcohol or drugs abuse, habitual smoking.
- •Patient whose adipose tissue obtained by liposuction is insufficient to manufacture the Investigational product at the intended dose.
- •Patient who is not able to understand the objective of the study or to comply with the study requirements.
- •Patient who is considered by the investigator to have a significant disease which might impact the study.
- •Patient who is considered not suitable for the study by investigator.
- •Patient who is Active Crohn's disease with CDAI 450 or higher.
- •Patient with medical history of surgery for malignant cancer in the past 5 years.(Except for carcinoma in situ)
- •Patient who exceeds 2 cm in the longest diameter of fistula.
- •Patient who dosed anti-TNF formulations such as infliximab, adalimumab, certolizumab within 3 months prior to injection.
研究组 & 干预措施
ASC (test arm)
Experimental
(Autologous Adipose-derived Mesenchymal Stem Cells)
干预措施: ASC (Biological)
Fibringlue
Placebo Comparator
Standard comparator
干预措施: Fibringlue (Drug)
结局指标
主要结局
Proportion of subjects who are completely blocked fistula
时间窗: In the 8th week after 1st injection
complete blockage
次要结局
- Proportion of subjects who are completely blocked fistula(During 12 months after injection)
- Score of evaluation about Investigator satisfaction using questionnaire(In the 8th week, 6th month and 12th month after final injection)
- Proportion of subjects who are more than 50% blocked fistula(During 12 months after injection)
- Proportion of subjects who are confirmed maintenance of fistula blockage by radiology test(Between 6th month and 12th month after final injection)
- Visual improvement effect of perianal fistula wound through photography of it(Immediately before and after the injection(intervention) and during 12 months after injection(intervention))
研究者
研究点 (4)
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